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Bipolar Disorder Research and New Medicine Trials

 


Olanzapine Compared to Divalproex and Placebo in the Treatment of Mild to Moderate Mania Associated with Bipolar I Disorder

This study is currently recruiting patients.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company

Purpose

The goals of this study are: A. To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania. B. To assess the safety of olanzapine and any side effects that might be associated with it, as well as the quality of life and functioning of patients treated with olanzapine. C. To assess how olanzapine compares to divalproex.

Condition Treatment or Intervention Phase
Bipolar Disorder
 Drug: Olanzapine
 Drug: Divalproex
Phase IV

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • You must be 18 to 65 years old.
  • You must have a diagnosis of bipolar I disorder and must be experiencing a manic or mixed (symptoms of mania and depression occurring together) episode.
  • You must be able to visit the doctor's office as scheduled for 15 weeks.
  • All female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception.

Exclusion Criteria:

  • You have rapid cycling bipolar disorder, or are having hallucinations or delusions, or are feeling suicidal.
  • You are pregnant or breastfeeding
  • You have a history of: inadequately controlled diabetes; heart disease; narrow angle glaucoma; low white blood cell or platelet count; have a positive test result for human immunodeficiency virus (HIV+); or any other serious, unstable illnesses as judged by the study physician.

Location and Contact Information

"There may be multiple sites in this clinical trial."      1-877-CTLILLY (1-877-285-4559) 

Georgia
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Atlanta,  Georgia,  United States; Recruiting

      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Marietta,  Georgia,  United States; Recruiting

Kentucky
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Florence,  Kentucky,  United States; Recruiting

Nevada
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Reno,  Nevada,  United States; Recruiting

Pennsylvania
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Media,  Pennsylvania,  United States; Recruiting

Texas
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Austin,  Texas,  United States; Recruiting

      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Houston,  Texas,  United States; Recruiting

Washington
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-285-4559) or speak with your personal physician.", Bellevue,  Washington,  United States; Recruiting

More Information

Study ID Numbers:  7029
Record last reviewed:  October 2004
Record first received:  October 20, 2004
ClinicalTrials.gov Identifier:  NCT00094549
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27

A Study of Aripiprazole in Patients with Bipolar I Disorder with a Major Depressive Episode

This study is currently recruiting patients.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb

Purpose

The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.

Condition Treatment or Intervention Phase
Bipolar I Disorder
 Drug: aripiprazole
Phase III

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Men and women, ages 18-65
  • Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.

Location and Contact Information

BMS Call Center      1-866-892-1BMS  Ext. 123 

California
      Local Institution, Long Beach,  California,  United States; Recruiting

More Information

Study ID Numbers:  CN138-146
Record last reviewed:  October 2004
Record first received:  October 18, 2004
ClinicalTrials.gov Identifier:  NCT00094432
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27

Acute Treatment of Bipolar II Depression

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to compare the medications lithium (Li) and lamotrigine (LTG) in treating depression in individuals with bipolar II disorder.

Condition Treatment or Intervention Phase
Bipolar Depression
 Drug: Lithium
 Drug: Lamotrigine
Phase III

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  60

Study start: May 2003

Bipolar II disorder (BDII) is a serious condition characterized by depressive and hypomanic episodes. The disability and suicide risk associated with BDII is equal to bipolar I disorder. However, there are no clinical trials for BDII, nor is the treatment of BDII addressed in current treatment guidelines. Data suggest that Li and LTG may be effective treatment options for BDII. This study will determine the safety, effectiveness, and tolerability of the two drugs in people with BDII.

Participants in this study will be randomly assigned to receive either Li or LTG for 16 weeks. Participants will be assessed every 2 weeks. One week after study completion, participants will have a follow-up visit. Measures of depression, mania, quality of life, functioning, and participant satisfaction will be taken.

Eligibility

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Current diagnosis of bipolar II disorder

Exclusion Criteria:

  • Use of lithium or lamotrigine
  • Intolerance to lithium or lamotrigine
  • Substance abuse or dependence within the last month
  • Suicidal thoughts
  • Unstable medical conditions
  • Pregnancy or breast-feeding
  • Stable on current medications
  • Use of fluoxetine (Prozac) within 2 weeks of study
  • Require an antipsychotic medication
  • Do not speak or read English

Location and Contact Information


Texas
      University of Texas Southwestern Medical Center at Dallas, Dallas,  Texas,  75390,  United States; Recruiting
Karla Figueroa, BS  214-648-6920    karla.figueroa@utsouthwestern.edu 
Eileen G Fischer, BS  214-648-6920    eileen.fischer@utsouthwestern.edu 
Trisha Suppes, MD, PhD,  Principal Investigator

More Information

Study ID Numbers:  MH67055-01A1
Record last reviewed:  October 2004
Record first received:  December 19, 2003
ClinicalTrials.gov Identifier:  NCT00074776
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27

Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder

This study is currently recruiting patients.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company

Purpose

The purpose of this study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar disorder in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.

Condition Treatment or Intervention Phase
Bipolar Disorder
 Drug: Olanzapine
Phase IV

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  130

Study start: November 2002;  Study completion: January 2006

Eligibility

Ages Eligible for Study:  13 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Male or female patients, 13 to 17 years of age who must not yet have reached their 18th birthday prior to Visit 1, when informed consent is obtained.
  • Patients must have a diagnosis of bipolar I disorder and currently display an acute mania or mixed episode.
  • Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent.
  • Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.

Exclusion Criteria:

  • Female patients who are either pregnant or nursing.
  • Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder.
  • Patient with acute or unstable medical conditions, such that intensive care unit hospitalization for the disease is anticipated within 6 months.
  • Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
  • Patients who have been judged clinically to be serious suicidal risks.

Location and Contact Information

There may be multiple sites in this clinical trial      1-877-CTLILLY (1-877-285-4559) 

Arkansas
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Little Rock,  Arkansas,  United States; Recruiting

California
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Cerritos,  California,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, San Diego,  California,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Vista,  California,  United States; Recruiting

District of Columbia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Washington,  District of Columbia,  United States; Recruiting

Florida
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Jacksonville,  Florida,  United States; Recruiting

Georgia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Atlanta,  Georgia,  United States; Recruiting

Idaho
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Boise,  Idaho,  United States; Recruiting

Louisiana
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Lake Charles,  Louisiana,  United States; Recruiting

Maine
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Bangor,  Maine,  United States; Recruiting

Missouri
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Chesterfield,  Missouri,  United States; Recruiting

Nevada
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Las Vegas,  Nevada,  United States; Recruiting

New Jersey
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Cherry Hill,  New Jersey,  United States; Recruiting

New Mexico
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Albuquerque,  New Mexico,  United States; Recruiting

New York
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, New York,  New York,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Olean,  New York,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Rochester,  New York,  United States; Recruiting

Ohio
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Beachwood,  Ohio,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Cincinnati,  Ohio,  United States; Recruiting

Tennessee
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Madison,  Tennessee,  United States; Recruiting

Texas
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Houston,  Texas,  United States; Recruiting

Washington
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Bellevue,  Washington,  United States; Recruiting

Puerto Rico
      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, San Juan,  Puerto Rico; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician., Rio Piedras,  Puerto Rico; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician, Cidra,  Puerto Rico; Recruiting

More Information

Study ID Numbers:  4360
Record last reviewed:  April 2004
Record first received:  November 26, 2002
ClinicalTrials.gov Identifier:  NCT00050206
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27

Treatment and Outcome of Early Onset Bipolar Disorder

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

This study aims to enroll children and adolescents between the ages of 10 to 18 years old who have bipolar I disorder with aggressive and/or psychotic features. The purpose of this study is to assess if continuing antipsychotic medication after at least six months of combination treatment with a mood stabilizer and antipsychotic medication is necessary after the psychotic features or aggressive behavior have resolved.

Condition Treatment or Intervention Phase
Bipolar Disorder
 Drug: Lithium
 Drug: Olanzapine
 Drug: Divalproex
 Drug: Risperidone
 Drug: Quetiapine
 Drug: Ziprasidone
 Drug: Aripriprazole
Phase IV

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  80

Study start: August 2002;  Study completion: August 2007

In children and adolescents, bipolar disorder is often accompanied by symptoms such as hallucinations, delusions, or paranoia that require acute treatment with a combination of an atypical antipsychotic medication and a mood stabilizer. It is not known if it is necessary to continue treatment with the atypical antipsychotic medication after the child's symptoms have remitted.

Participants in this study are treated with lithium or divalproex (Depakote)and one of the following atypical antipsychotic medications: olanzapine (Zyprexa), risperidone (Risperdal), quetiapine (Seroquel), ziprasidone (Geodon) or aripriprazole (Abilify) for at least 24 weeks. Participants who have already begun combination therapy with at least one of the mood stabilizers and atypical antipsychotic medications listed above are also encouraged to enroll in this study. After participants have been on combination therapy for at least 24 weeks they will then be randomly assigned to one of two groups. The first group will continue to receive active mood stablizer and atypical antipsychotic medication. The second group will receive active mood stabilizer and placebo. Participants are assessed weekly and followed for up to 18 months.

Eligibility

Ages Eligible for Study:  10 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

  • Have a diagnosis of Bipolar I Disorder;
  • Have had aggressive and/or psychotic features (delusions, hallucinations and/or thought disorder) during the most recent manic episode;
  • Is willing to be treated or is already being treated with the combination of mood stabilizer(s) (lithium or Depakote) and an atypical antipsychotic medication (Abilify, Geodon, Risperdal, Seroquel, or Zyprexa);
  • Live in the NY Metropolitan area;
  • Able to attend weekly to biweekly office visits

Exclusion Criteria:

  • Medical contraindication to treatment with lithium and divalproex
  • Seizure disorder
  • Pregnancy
  • Unwillingness to use acceptable methods of birth control if sexually active
  • IQ less than 70
  • Substance-induced mood disorder or mood disorder due to a general medical condition
  • Prior experience with re-emergence of psychotic features or severe aggression within 6 months of antipsychotic medication discontinuation under circumstances similar to those in the study
  • Potentially lethal suicide attempts or infliction of serious injury upon someone during most severe bipolar episode
  • High risk for running away or truancy

Location and Contact Information


New York
      The Zucker Hillside Hospital, Long Island Jewish Medical Center, Glen Oaks,  New York,  11004,  United States; Recruiting
Alison Berest, BS  718-470-8444    aberest@lij.edu 
Vivian Kafantaris, MD,  Principal Investigator

More Information

Publications

Kafantaris V, Coletti DJ, Dicker R, Padula G, Kane JM. Adjunctive antipsychotic treatment of adolescents with bipolar psychosis. J Am Acad Child Adolesc Psychiatry. 2001 Dec;40(12):1448-56.

Kafantaris V. Treatment of bipolar disorder in children and adolescents. J Am Acad Child Adolesc Psychiatry. 1995 Jun;34(6):732-41. Review.

Kafantaris V, Coletti DJ, Dicker R, Padula G, Kane JM. Lithium treatment of acute mania in adolescents: a large open trial. J Am Acad Child Adolesc Psychiatry. 2003 Sep;42(9):1038-45.

Study ID Numbers:  60845-01A1
Record last reviewed:  June 2004
Record first received:  November 8, 2002
ClinicalTrials.gov Identifier:  NCT00048802
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27

Clozapine for Treatment-Resistant Mania

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

The purpose of this study is to evaluate the safety and effectiveness of clozapine as a treatment for the manic phase of bipolar disorder.

A significant proportion of manic patients either do not respond adequately to conventional treatment or cannot tolerate the adverse effects associated with therapeutic doses of these agents. Clozapine may be a safe and effective treatment for mania. However, the efficacy of clozapine as an alternative therapy in treatment-resistant bipolar disorder mania has not been extensively researched.

The study will be conducted in three phases. Phase 1 is a screening phase that will take place for 2 to 7 days. Participants will undergo a baseline positron emission tomography (PET) scan of the brain at the end of this period. In Phase 2, participants will be randomly assigned to receive either clozapine or placebo (an inactive pill) for 3 weeks. They may also receive lorazepam for the first 10 days of Phase 2. After 3 weeks, patients treated with clozapine will undergo a second PET scan. During Phase 3, participants who received placebo and did not improve will be offered clozapine for 3 weeks. Those who received clozapine and did not improve will receive other treatment for 3 weeks. At the end of Phase 3, participants who were treated with clozapine will have another PET scan.

Condition Phase
Bipolar Disorder
Phase II

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment, Safety/Efficacy

Official Title: A Double Blind Study Examining the Efficacy of Clozapine and a Study of the Pathophysiology in Treatment Resistant Mania

Further Study Details: 

Expected Total Enrollment:  42

Study start: January 2, 2002

A significant proportion of manic patients either do not respond adequately to conventional treatment (lithium, valproate or carbamazepine (with or without antipsychotic drugs), or cannot tolerate the adverse effects associated with therapeutic doses of these agents. Thus, a need exists for additional effective treatments. Preliminary studies by our group suggest that clozapine may have antimanic actions and be effective in treatment-resistant bipolar disorder. However, the efficacy of clozapine as an alternative therapy in treatment-resistant mania has never been subjected to definitive study with an adequate number of subjects. Thus, we propose to conduct the largest and only double-blind, placebo-controlled trial to date, of clozapine, in bipolar manic patients who were unresponsive or intolerant to six weeks of treatment with lithium, valproate, carbamazepine and at least one antipsychotic drug. The specific aims of this investigation are to 1) assess the acute treatment efficacy of clozapine in treatment-resistant mania, 2) to investigate the functional anatomical correlates of mania, and 3) to investigate the effects of clozapine treatment on cerebral glucose metabolism and metabolic correlates of effective antimanic, clozapine treatment. Forty-two subjects (two groups of 21 each) will be randomly assigned to treatment with clozapine or placebo for three weeks. We anticipate that a maximum of 33% of patients will be withdrawn from the acute phase of the study due to reasons such as intolerable adverse effects or withdrawal of consent. Thus, we expect the entered sample to yield 14 completed subjects per cell. This sample size will allow for adequate statistical power to test the hypotheses stated above. Patients, ages 18-60, with a diagnosis of bipolar I disorder manic or mixed (with or without psychotic features), will be randomized to double-blind treatment to receive either clozapine (200-550 mg/day) or placebo, for a period of 3 weeks. Following this acute period, the patients will receive either open-label clozapine or treatment as clinically indicated. If clozapine is found effective in treatment-resistant mania, it would be a significant step forward in the treatment of these patients and would have major health implications. In addition, it would establish a gold standard against which newer treatments can be compared to. Finally, glucose metabolism images will be obtained using PET and [F-18] FDG at baseline and following 3 weeks of clozapine treatment to investigate the functional anatomical correlates of mania and to compare drug-induced metabolic changes between responders and nonresponders.

Eligibility

Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:
Males or females 18 to 60 years of age;
Diagnosis: DSM-IV Bipolar I Disorder, current episode manic or mixed with or without psychotic features as determined by SCID-P. This criteria includes the following diagnoses: 296.4X, Bipolar I Disorder, Most Recent Episode Manic, and 296.6X, Bipolar I Disorder, Most Recent Episode Mixed;
YMRS greater than or equal to 20 at Visits 1 and 2;
No decrease in total score of YMRS of greater than or equal to 20% during washout (between Visits 1 and 2);
Meet criteria for treatment resistance.
Patients must have experienced at least two manic or mixed episodes within five years prior to study entry and one manic or mixed episode being within the last 12 months (not including the current episode); DSM-IV rapid cyclers will be permitted to participate in this study;
Each patient must have a level of understanding sufficient to agree to all the tests required by the protocol;
Each patient must understand the nature of the study and must sign an informed consent document. It is recommended, but not required, that an NIH Advanced Directive form be completed.
EXCLUSION CRITERIA:
WBC count is less than 3500/mm(3) or history of a myeloproliferative disorder.
History of meeting criteria for DSM-IV criteria for schizophrenia or other psychotic disorder;
History of DSM-IV substance abuse, including alcohol within the last three months and substance dependence (except nicotine and caffeine) within the past 5 years;
Acute or unstable medical illnesses, (e.g., delirium, metastatic cancer, unstable diabetes, decompensated cardiac, hepatic, renal or pulmonary disease, or stroke or myocardial infarction within the last six months);
Current pregnancy or plan to become pregnant during the first three months (the duration of the study) in woman of childbearing age; breast-feeding in woman with infants;
Previous treatment with clozapine;
History of seizures;
History of leukopenia or agranulocytosis;
Uncorrected hypo- or hyperthyroidism;
Elevated thyroid stimulating hormone (TSH) greater than or equal to 5.0 micro U/ml;
Concomitant use carbamazepine or other concomitant medication with primarily CNS activity; Has received an investigational drug within 30 days of enrollment.
Has received an antidepressant within 4 weeks prior to Visit 1 (8 weeks for fluoxetine);
Treatment with an oral antipsychotic drug within 5 half-lives prior to Visit 2;
No course of ECT (electroconvulsive therapy) within the preceding 4 weeks to Visit 1;
Treatment with an injectable depot neuroleptic within less than one dosing interval prior to Visit 1;
Is actively suicidal, and/or has a score of 3 or more on item 3 of the HAMD;
Has an acute or chronic illness likely to impair drug absorption, distribution, metabolism or excretion;
General MRI exclusion criteria.

Location and Contact Information


Maryland
      National Institute of Mental Health (NIMH), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting
Patient Recruitment and Public Liaison Office  1-800-411-1222    prpl@mail.cc.nih.gov 
TTY  1-866-411-1010 

More Information

Detailed Web Page

Publications

Ahlfors UG, Baastrup PC, Dencker SJ, Elgen K, Lingjaerde O, Pedersen V, Schou M, Aaskoven O. Flupenthixol decanoate in recurrent manic-depressive illness. A comparison with lithium. Acta Psychiatr Scand. 1981 Sep;64(3):226-37.

Black DW, Winokur G, Hulbert J, Nasrallah A. Predictors of immediate response in the treatment of mania: the importance of comorbidity. Biol Psychiatry. 1988 Jun;24(2):191-8.

Calabrese JR, Markovitz PJ, Kimmel SE, Wagner SC. Spectrum of efficacy of valproate in 78 rapid-cycling bipolar patients. J Clin Psychopharmacol. 1992 Feb;12(1 Suppl):53S-56S.

Study ID Numbers:  020085; 02-M-0085
Record last reviewed:  December 8, 2003
Last Updated:  December 8, 2003
Record first received:  January 11, 2002
ClinicalTrials.gov Identifier:  NCT00029458
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27

Brain Imaging in Depression

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

The purpose of this study is to use brain imaging technology to examine the role of certain brain receptors and the nervous system chemical acetylcholine in major depression.

The cholinergic system involves the regulation of neurotransmitters and the brain receptors to which they bind. Evidence suggests that the cholinergic system may play a role in the development of depression. Acetylcholine is a neurotransmitter that binds to certain brain receptors called muscarinic cholinergic receptors. Cholinomimetic drugs (drugs that stimulate the cholinergic system) often exacerbate depressive symptoms in people with mood disorders and in healthy individuals. This increase in depressive symptoms may be caused by stimulation of muscarinic acetylcholine receptors (mAChRs), but further study is needed to confirm this. This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI) to study the function of mAChRs in individuals with depression.

Participants in this study will undergo a physical examination, psychiatric interviews, neuropsychological tests, PET and MRI scans, and rating scales of depression, anxiety, and negative thinking symptoms. Questions about behavior and functioning will be asked and blood samples will be collected for genetic analysis.

Condition Treatment or Intervention
Depression
Bipolar Disorder
 Drug: [O-15] Water
 Drug: [F-18] FP-TZTP

MedlinePlus related topics:  Bipolar Disorder;   Depression

Study Type: Observational
Study Design: Natural History

Official Title: Muscarinic Cholinergic Receptor Imaging in Depression

Further Study Details: 

Expected Total Enrollment:  80

Study start: December 16, 2002

Several paths of evidence converge in implicating a role for the cholinergic system in the pathophysiology of affective illness. In both unipolar depressed and euthymic bipolar subjects, cholinomimetic drugs (i.e., muscarinic agonists, acetylcholinesterase inhibitors) exacerbate depressive signs and symptoms such as dysphoria, psychomotor retardation, impairment of attention and memory, hypothalamic pituitary adrenal axis hyperactivity and sleep EEG abnormalities. In healthy subjects, the acetylcholinesterase inhibitor physostigmine elicits a range of depressive symptoms including dysphoria, anergia, psychomotor slowing, emotional lability, sleep disturbances, memory and concentration impairment, and with higher doses, tearfulness and depression. These effects have been shown to reflect stimulation of muscarinic receptors. Cholinomimetics also exacerbate behavioral despair in putative animal models of depression. Conversely, the anticholinergic agent biperidine improved symptoms of depression in a placebo controlled study. Moreover, muscarinic cholinomimetics and a choline rich nutrient, lecithin (phosphatidylcholine) exert antimanic effects in bipolar subjects.

Potentially consistent with these observations, depressed subjects exhibit hypersensitivity to cholinomimetic agents. Administration of muscarinic cholinergic agonists, ACh releasing agents or acetylcholinesterase inhibitors induce exaggerated effects on REM density and latency in depressed subjects than in healthy controls. In addition, both manic and depressed bipolar subjects show increased pupillary sensitivity to the muscarinic cholinergic agonist pilocarpine relative to controls.

Despite the data implicating the mAChR receptor system in mood disorders, no direct in vivo investigations of the central mAChR have been performed in depressed subjects. A novel PET radioligand, [(18)F]FP-TZTP was recently developed by Eckelman as a selective agonist of M(2) receptors. Because the M(2) receptor functions predominately as a presynaptic release-controlling autoreceptor, decreased distribution volume (V) of this receptor could conceivably give rise to increased postsynaptic muscarinic receptor sensitivity.

This application proposes a pilot PET study of M(2) receptor distribution volume in currently depressed subjects with major depressive disorder (n=20), currently depressed subjects with bipolar disorder (n=20), and psychiatrically healthy controls (n=20). The proposed pilot study will test the central hypothesis that M(2) receptor V is decreased in regions where they are primarily located presynaptically in depressed subjects relative to healthy controls. The proposed study will advance knowledge regarding the pathophysiology of depression.

Eligibility

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

INCLUSION CRITERIA - MDD Depressed Sample:
Twenty subjects (ages 18-50) male and female will be selected, with primary MDD currently depressed as defined by DSM-IV criteria for recurrent MDD and current HDRS score in the moderately-to-severely depressed range (greater than 18) and who have a first degree relative with MDD but no first degree relatives with mania, alcoholism, or antisocial personality disorder.
INCLUSION CRITERIA - Bipolar Depressed Sample:
Twenty subjects (aged 18-50) male and female will be selected who meet DSM-IV criteria for bipolar I or II disorder and are currently depressed, with HDRS score in the moderately-to-severely depressed range (greater than 18). Subjects may be inpatients or outpatients. Because effective treatment will not be discontinued for the purposes of this protocol, subjects will be identified who have never been treated or who have discontinued medication due to lack of efficacy, noncompliance, physician order, or other reasons prior to study entry.
INCLUSION CRITERIA - Healthy, Control Sample:
Twenty subjects (ages 18-50) male and female who have not met criteria for any major psychiatric disorder will be selected. From this large sample a control subject will be matched to each depressed subject for age, gender, handedness and stage of menstrual cycle. The control subjects will have no known first degree relatives with mood disorders.
EXCLUSION CRITERIA:
Subjects must not have taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular function for at least 3 weeks (8 weeks for fluoxetine and for any drug with known anticholinergic effects) prior to scanning. Because effective medications will not be discontinued for the purposes of this study, subjects will be identified who have never been treated or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reasons prior to study entry. Subjects will also be excluded if they: a) have had serious suicidal ideation or behavior in the previous two months, or if they have b) had any significant comorbid condition in the last year, c) psychosis to the extent that the ability to provide informed consent is in doubt, d) history of any major psychiatric disorder (other than the target mood disorder) arising temporally before the initial mood episode, e) medical or neurological illnesses (i.e. seizure disorder, a coma in past) likely to affect physiology or anatomy, f) a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM IV criteria), g) are HIV positive or have AIDS, h) current pregnancy (documented by history and pregnancy testing prior to scanning), i) current breast feeding, j) general MRI exclusion criteria which include the subject having a pacemaker or significant claustrophobia and k) if they are smokers.

Location and Contact Information


Maryland
      National Institute of Mental Health (NIMH), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting
Patient Recruitment and Public Liaison Office  1-800-411-1222    prpl@mail.cc.nih.gov 
TTY  1-866-411-1010 

More Information

Detailed Web Page

Publications

Allen TG. The role of N-, Q- and R-type Ca2+ channels in feedback inhibition of ACh release from rat basal forebrain neurones. J Physiol. 1999 Feb 15;515 ( Pt 1):93-107.

Arango V, Underwood MD, Boldrini M, Tamir H, Kassir SA, Hsiung S, Chen JJ, Mann JJ. Serotonin 1A receptors, serotonin transporter binding and serotonin transporter mRNA expression in the brainstem of depressed suicide victims. Neuropsychopharmacology. 2001 Dec;25(6):892-903.

Baratti CM, Opezzo JW, Kopf SR. Facilitation of memory storage by the acetylcholine M2 muscarinic receptor antagonist AF-DX 116. Behav Neural Biol. 1993 Jul;60(1):69-74.

Study ID Numbers:  030001; 03-M-0001
Record last reviewed:  September 2, 2003
Last Updated:  September 2, 2003
Record first received:  December 17, 2002
ClinicalTrials.gov Identifier:  NCT00050700
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27

Brain Tissue Collection for Neuropathological Studies

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

The purpose of this study is to collect and study the brain tissue of deceased individuals to learn more about the nervous system and mental disorders. Information gained from donated tissue may lead to better treatments and potential cures for nervous system and mental disorders.

This study will ask relatives of deceased individuals to donate the brains of their deceased relatives to allow further study of neurological and psychiatric disorders.

Condition
Bipolar Disorder
Huntington Disease
Schizophrenia
Tourette Syndrome
Dementia

MedlinePlus related topics:  Bipolar Disorder;   Dementia;   Huntington's Disease;   Schizophrenia;   Tourette Syndrome
Genetics Home Reference related topics:  Huntington disease

Study Type: Observational
Study Design: Natural History

Official Title: Brain Procurement for the Neuropathology Section, CBDB

Further Study Details: 

Expected Total Enrollment:  1250

Study start: May 29, 1990

The knowledge of how affected tissue deviates from normal control tissue is an integral part of fully understanding a neurological or psychiatric disorder. The purpose of this protocol is to establish a coordinating program with the pathology departments of the Washington, D.C. and metropolitan area hospitals and local medical examiner's offices for the donation of brain tissue.

Eligibility

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

INCLUSION CRITERIA:
Individuals suffering from a variety of neuropsychiatric disorders, especially schizophrenia, but also Huntington's chorea, suicide, manic-depressive illness, depression, Tourette's Syndrome, drug addictions (PCP, cocaine, alcohol, heroin or the like) and any form of dementia.
Brain tissue from afflicted individuals is needed for the study.
Brains (fresh or preserved tissue) from normal individuals without a history of neuropsychiatric disease.

Location and Contact Information


Maryland
      National Institute of Mental Health (NIMH), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting
Joel E. Kleinman, M.D.  3014027909    kleinmaj@intra.nimh.nih.gov 

More Information

Detailed Web Page

Publications

Ohuoha DC, Knable MB, Wolf SS, Kleinman JE, Hyde TM. The subnuclear distribution of 5-HT3 receptors in the human nucleus of the solitary tract and other structures of the caudal medulla. Brain Res. 1994 Feb 21;637(1-2):222-6.

Hitri A, Casanova MF, Kleinman JE, Wyatt RJ. Fewer dopamine transporter receptors in the prefrontal cortex of cocaine users. Am J Psychiatry. 1994 Jul;151(7):1074-6.

Wolf SS, Hyde TM, Moody TW, Saunders RC, Weinberger DR, Kleinman JE. Autoradiographic characterization of 125I-neurotensin binding sites in human entorhinal cortex. Brain Res Bull. 1994;35(4):353-8.

Study ID Numbers:  900142; 90-M-0142
Record last reviewed:  May 28, 2004
Last Updated:  May 28, 2004
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001260
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27

Treatment of Early Age Mania

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to evaluate the effectiveness of the drugs lithium, valproate, and risperidone in treating children and adolescents with bipolar disorder or symptoms of mania.

Condition Treatment or Intervention Phase
Bipolar Disorder
Manic Disorder
 Drug: Lithium
 Drug: Valproate
 Drug: Risperidone
Phase III

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Treatment of Early Age Mania (TEAM) Study

Further Study Details: 

Expected Total Enrollment:  540

Study start: February 2003;  Study completion: December 2007

Patients are randomly assigned to receive lithium (Eskalith), valproate (Depakote), or risperidone (Risperdal) for 8 to 16 weeks. They will have weekly visits to monitor their response to the medication. When the study is complete, care will be transferred to the child's treating psychiatrist.

Eligibility

Ages Eligible for Study:  6 Years   -   14 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • DSM-IV criteria for bipolar I (manic or mixed) or mania for at least 4 weeks
  • CGAS <= 60
  • Good physical health

Exclusion Criteria:

  • Schizophrenia or any pervasive developmental disorder
  • Major medical or neurological disease
  • History of addiction to illicit substances or alcohol or drug abuse within the last 4 weeks
  • IQ < 70
  • Pregnancy or breast-feeding
  • Unacceptable methods of contraception
  • In-patient care at baseline

Location and Contact Information

Barbara Geller, MD       gellerb@medicine.wustl.edu

District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  United States; Recruiting
Thalia Attinger  202-884-2681    pjoshi@cnmc.org 
Paramjit Joshi, MD,  Principal Investigator

Maryland
      Johns Hopkins Medical Center, Baltimore,  Maryland,  United States; Recruiting
Sam Walford, MA  410-955-1542    swalford@jhmi.edu 
John Walkup, MD,  Principal Investigator

Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  United States; Recruiting
Samantha Blankenship, M.S.W  314-286-2783    blankens@msnotes.wustl.edu 
Joan Luby, MD,  Principal Investigator

Pennsylvania
      University of Pittsburgh/WPIC, Pittsburgh,  Pennsylvania,  United States; Recruiting
Annette Baughman  800-518-0370    baughmanam@msx.upmc.edu 
David Axelson, MD,  Principal Investigator

Texas
      University of Texas, Galveston,  Texas,  United States; Recruiting
Candice Hausler, MA  281-335-5403    cahausle@utmb.edu 
Cheryl Pierce, MA  281.335.4764    crpierce@utmb.edu 
Karen Wagner, MD,  Principal Investigator

More Information

Study ID Numbers:  1RO1MH064846-01 A1; 64851; 64911; 64868; 64887; 64850; 64869
Record last reviewed:  October 2004
Record first received:  April 4, 2003
ClinicalTrials.gov Identifier:  NCT00057681
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27

Optimizing Electroconvulsive Therapy for Depression

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to evaluate electroconvulsive therapy (ECT) administered concurrently with antidepressant medication. This study will also compare two different types of ECT.

Condition Treatment or Intervention Phase
Depression
Depressive Disorder
Bipolar Disorder
 Procedure: Electroconvulsive therapy
 Drug: Nortriptyline
 Drug: Venlafaxine
 Drug: Lithium
Phase IV

MedlinePlus related topics:  Bipolar Disorder;   Depression;   Mental Health

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Optimization of Electroconvulsive Therapy

Further Study Details: 

Expected Total Enrollment:  630

Study start: February 2001;  Study completion: January 2006

This study addresses 2 issues in the optimization of ECT in patients with major depression: whether patients treated with ECT should receive concurrent treatment with antidepressant medications, and the relative efficacy and side effects of high dosage right unilateral (RUL) ECT compared to low dosage bilateral (BL) ECT.

This study has 2 phases. In Phase I, patients are randomized to receive nortriptyline, venlafaxine (Effexor), or placebo while they simultaneously receive either high dosage RUL ECT or low dosage BL ECT. Patients have an electrocardiogram (EKG), a chest x-ray, medical and neurological examinations, and blood tests. Memory function is assessed before and after ECT. Whenever feasible, patients are withdrawn from all prior psychotropic medication before the start of ECT. ECT is administered 3 times per week to inpatients and twice a week to outpatients. Patients continue ECT until they are asymptomatic or until there is a plateau in improvement over 2 treatments.

Patients who respond to ECT enter Phase II and add lithium to either nortriptyline or venlafaxine within 1-3 days of the last ECT. Clinical and side effect evaluations and blood level determinations are conducted weekly for the first month, every 2 weeks until Week 12, and every 4 weeks for the remaining 12 weeks. Following any indication of relapse, patients are monitored more intensively and are re-evaluated within 1 week. The neurocognitive battery is readministered to all patients at 2 and 6 months after the acute ECT course, regardless of ECT clinical outcome.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Major depressive episode (unipolar or bipolar)
  • Pre-ECT score of 20 or higher on Hamilton Rating Scale for Depression
  • Able to withdraw psychotropic drugs (up to 3 mg/day lorazepam allowed)
  • ECT indicated

Exclusion Criteria:

  • Schizophrenia, schizoaffective disorder, or other psychosis
  • Amnestic disorder, dementia, or delirium
  • Pregnancy
  • Epilepsy
  • Current alcohol or substance abuse or dependence
  • CNS disease or brain injury not associated with psychotropic drug exposure
  • ECT in the past 6 months
  • Medical contraindication for treatment with either nortriptyline or venlafaxine, including allergy to amitriptyline, nortriptyline, or venlafaxine; narrow angle glaucoma; sinus node disease; bundle branch disease; myocardial infarction; coronary artery bypass or angioplasty; or angina
  • Type I antiarrhythmic medication
  • Supine blood pressure >= 170 mmHg systolic or >= 105 mmHg diastolic at 3 readings over 2 days

Location and Contact Information

Harold A Sackeim, Ph.D.      212 543-5855    has1@columbia.edu

Missouri
      Washington University, Saint Louis,  Missouri,  63110,  United States; Recruiting
Keith E Isenberg, M.D.  314-362-1839    isenberk@psychiatry.wustl.edu 
Keith E Isenberg, M.D.,  Principal Investigator

New York
      New York State Psychiatric Institute at Columbia University, New York,  New York,  10032,  United States; Recruiting
Harold A Sackeim, Ph.D.  212-543-5855    has1@columbia.edu 
Joan Prudic, M.D.  212 543-5616    jp33@columbia.edu 
Harold A. Sackeim, Ph.D.,  Principal Investigator
Thomas Cooper, M.A.,  Sub-Investigator
Jean Endicott, Ph.D.,  Sub-Investigator
Joan Prudic, M.D.,  Sub-Investigator
Steven P. Roose, M.D.,  Sub-Investigator

North Carolina
      Wake Forest University, Winston Salem,  North Carolina,  27103,  United States; Recruiting
Vaughn McCall, M.D.  336-716-2911    vmccall@wfubmc.edu 
Vaughn McCall, Ph.D.,  Principal Investigator

Pennsylvania
      Western Psychiatric Institute and Clinic, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Roger F Haskett, M.D.  412-624-6662    haskettrf@msx.upmc.edu 
Roger F Haskett, M.D.,  Principal Investigator

Study chairs or principal investigators

Harold A Sackeim, Ph.D.,  Study Chair,  New York State Psychiatric Institute and Columbia University   

More Information

Publications

Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307.

Sackeim HA, Prudic J, Devanand DP, Nobler MS, Lisanby SH, Peyser S, Fitzsimons L, Moody BJ, Clark J. A prospective, randomized, double-blind comparison of bilateral and right unilateral electroconvulsive therapy at different stimulus intensities. Arch Gen Psychiatry. 2000 May;57(5):425-34.

McCall WV, Reboussin DM, Weiner RD, Sackeim HA. Titrated moderately suprathreshold vs fixed high-dose right unilateral electroconvulsive therapy: acute antidepressant and cognitive effects. Arch Gen Psychiatry. 2000 May;57(5):438-44.

Study ID Numbers:  61609-01A1
Record last reviewed:  March 2004
Record first received:  September 13, 2002
ClinicalTrials.gov Identifier:  NCT00045916
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27

 

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