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Bipolar Disorder Research and New Medicine Trials

 


Relapse Prevention for Bipolar Type-II 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

The purpose of this study is to determine the safety and effectiveness of fluoxetine (Prozac) in treating and preventing recurrent bipolar (manic depressive) type II episodes.

Condition Treatment or Intervention Phase
Bipolar Disorder
Depression
 Drug: Fluoxetine
 Drug: Lithium
Phase IV

MedlinePlus related topics:  Bipolar Disorder;   Depression

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

Official Title: Relapse Prevention of Bipolar Type-II Disorder

Further Study Details: 

Expected Total Enrollment:  180

Bipolar II (BP II) disorder is characterized by a high recurrence of major depressive episodes (MDE), and it is associated with substantial illness and deaths. Unfortunately, relatively little attention has been given to treatment of BP II. Concern that patients may switch from depressed to manic states during treatment of MDE has impeded the development of effective treatments for BP II MDE.

BP II MDE patients are treated initially with fluoxetine for 10 weeks. Patients who recover from MDE are then randomized to receive a relapse-prevention treatment of fluoxetine, lithium, a combination of fluoxetine and lithium, or placebo for 1 year. Patients undergo clinical and laboratory evaluations, including physical examinations, bloodwork, thyroid function tests, electrocardiogram (ECG), urinalysis, and HAM-D, YMR, CGI-S, CGI-I, and adverse events scales.

Eligibility

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

Criteria

Inclusion Criteria:

  • Bipolar II Depression

Location and Contact Information


Pennsylvania
      Depression Research Unit, Univ Penn, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Jay D Amsterdam, MD  215-662-3462    jamsterd@mail.med.upenn.edu 
Maryanne Giampapa, BA  215-662-2835    mgiampap@mail.med.upenn.edu 
Jay D Amsterdam, MD,  Principal Investigator

More Information

Study ID Numbers:  60353-01A2
Record last reviewed:  August 2004
Record first received:  September 3, 2002
ClinicalTrials.gov Identifier:  NCT00044616
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27

Depression And Bipolar Disorder Drug Trial

This study is currently recruiting patients.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline

Purpose

This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.

Condition Treatment or Intervention Phase
Bipolar Disorder
 Drug: Investigational Bipolar Disorder Drug
Phase III

MedlinePlus related topics:  Bipolar Disorder

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

Eligibility

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

Criteria

Inclusion

  • Patients must provide written and informed consent.
  • Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks.

Exclusion

  • Patients must not be suicidal.
  • Patients must not have a history of non-response to antidepressant treatment.
  • Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry.
  • Patients must not have had epilepsy or hypothyroidism.

Location and Contact Information


California
      Study Site (014), Los Angeles,  California,  90048,  United States; No longer recruiting

      Beverly Hills,  California,  90210,  United States; Recruiting
Study Coordinator  310-858-7448 

      San Diego,  California,  92108,  United States; Recruiting
Study Coordinator  619-688-6565 

      Santa Ana,  California,  92705,  United States; Recruiting
Study Coordinator  714-547-4100 

Georgia
      Marietta,  Georgia,  30060,  United States; Recruiting
Study Coordinator  770-422-2009 

Indiana
      Terre Haute,  Indiana,  47802,  United States; Recruiting
Study Coordinator  812-234-4899 

Kentucky
      Study Site (011), Florence,  Kentucky,  41042,  United States; Terminated

Louisiana
      Shreveport,  Louisiana,  71101,  United States; Not yet recruiting
Study Coordinator  318-227-9600 

New Jersey
      Clementon,  New Jersey,  08021,  United States; Recruiting
Study Coordinator  856-566-9000  Ext. 213 

      Princeton,  New Jersey,  08540,  United States; Recruiting
Study Coordinator  609-921-3555 

New York
      New York,  New York,  10021,  United States; Recruiting
Study Coordinator  212-772-3570 

      Bronx,  New York,  10467,  United States; Recruiting
Study Coordinator  716-920-4287 

North Carolina
      Raleigh,  North Carolina,  27609,  United States; Recruiting
Study Coordinator  919-872-5620 

Ohio
      Study Site (004), Cleveland,  Ohio,  44016,  United States; Terminated

      Beachwood,  Ohio,  44122,  United States; Not yet recruiting
Study Coordinator  216-514-1803 

Oregon
      Portland,  Oregon,  97210,  United States; Recruiting
Study Coordinator  503-276-6224 

      Eugene,  Oregon,  97401,  United States; Recruiting
Study Coordinator  541-341-6565 

South Carolina
      Columbia,  South Carolina,  29201,  United States; Recruiting
Study Coordinator  803-988-0080 

Texas
      Houston,  Texas,  77058,  United States; Recruiting
Study Coordinator  866-780-6663 

      Study Site (008), Houston,  Texas,  77090,  United States; Recruiting
Study Coordinator  281-893-4111 

      Galveston,  Texas,  77555,  United States; Recruiting
Study Coordinator  866-780-6663 

More Information

Study ID Numbers:  100223
Record last reviewed:  July 2004
Record first received:  February 5, 2004
ClinicalTrials.gov Identifier:  NCT00076882
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27

Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents

This study is currently recruiting patients.

Sponsored by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Purpose

The purpose of this study is to determine the safety and effectiveness of Risperidone compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.

Condition Treatment or Intervention Phase
Bipolar Disorder
 Drug: Risperidone
Phase III

MedlinePlus related topics:  Bipolar Disorder

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

Eligibility

Ages Eligible for Study:  10 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

KEY INCLUSION CRITERIA

  • Current primary diagnosis of bipolar I disorder, mania or mixed type
  • Aged between 10 and 17 years of age
  • Young Mania Rating Scale score greater than or equal to 20 at screening and baseline

KEY EXCLUSION CRITERIA

  • Known or suspected history of substance dependence
  • Significant risk for suicidal or violent behavior
  • Antidepressant or clozapine treatment within 4 weeks of baseline
  • Received a depot antipsychotic within 1 treatment cycle before baseline
  • Is unable to swallow medication taken in the form of tablets
  • Has a positive result for a urine drug screen done at baseline
  • Known or suspected seizure disorder
  • Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening
  • Known or suspected history of hypersensitivity or intolerance to risperidone
  • History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent

Location and Contact Information


Arkansas
      Pinnacle Pointe Hospital, Little Rock,  Arkansas,  72211,  United States; Recruiting
Roxanne Ballard  501-223-3322  Ext. 4777 

California
      Cedars Sinai Mediacl Center, Los Angeles,  California,  90048,  United States; Recruiting
Nstasha Taper  310-423-4552 

Florida
      Ted Broeck Hospital, Jacksonville,  Florida,  32216,  United States; Recruiting
Teresa Thode  904-724-9203 

      Segal Institute for Clinical Research, North Miami,  Florida,  33161,  United States; Recruiting
Toby Harden  305-891-0050 

Georgia
      CRCA, Stone Mountain,  Georgia,  300087,  United States; Recruiting
Ericka Copeland  770-465-2459 

Louisiana
      Institution for Neuropsychiatry, Lake Charles,  Louisiana,  70601,  United States; Recruiting
Susan Day  337-477-7091 

      LSU Health Sciences Center, Shreveport,  Louisiana,  14760,  United States; Recruiting
Barbara Roggero  318-675-6062 
Melanie Smith  318 675 6062 

Massachusetts
      Children's Hospital of Boston, Boston,  Massachusetts,  02115,  United States; Recruiting
Carlene MacMillan  617-355-5706 

Missouri
      Mercy Medical Group, St. Louis,  Missouri,  63017,  United States; Recruiting
Elizabeth Ganser  314-205-0007  Ext. 128 

      Millennium Psychiatric Associates, St. Louis,  Missouri,  63044,  United States; Recruiting
Kathy Zervis  314-344-7391 

New York
      Global Research and Consulting, Olean,  New York,  14760,  United States; Recruiting
Kari Lockwood  716-373-1094 

      University at Stony Brook, Stony Brook,  New York,  11794,  United States; Recruiting
RoseMary Citrola  631-632-8840 

Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting
Denise Beyoda  216-844-3881 

      Psychiatric Professional Services, Cincinnati,  Ohio,  45267,  United States; Recruiting
Holly Bryan  513-558-5847 

Oklahoma
      Cutting Edge Research Group, Oklahoma City,  Oklahoma,  73120,  United States; Recruiting
Brooke Gwynn  405-751-8113 

Texas
      MedLabs Research of Houston, Houston,  Texas,  77057,  United States; Recruiting
Julie Feldott  713-783-8889 

      University of Texas Medical Branch, Galveston,  Texas,  77555,  United States; Recruiting
Nikki Amaratunge  409-747-8330 

Utah
      University of Utah, Salt Lake City,  Utah,  84132,  United States; Recruiting
Ruth Mestas  801-581-8806 

Virginia
      Centers for Behavioral Health at Maryview, Portsmouth,  Virginia,  23703,  United States; Recruiting
Janet McNiff  757-398-2386 

      Virginia Treatment Center for Children, Richmond,  Virginia,  23298,  United States; Recruiting
Durre Khan  804-828-4058 

More Information

Study ID Numbers:  RIS-BIM-301
Record last reviewed:  September 2004
Record first received:  January 14, 2004
ClinicalTrials.gov Identifier:  NCT00076115
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27

Confirmatory Study of Seroquel® in the Treatment of Bipolar Depression

This study is currently recruiting patients.

Sponsored by: AstraZeneca
Information provided by: AstraZeneca

Purpose

The purpose of this study is to determine whether treatment with Seroquel® for two months is effective in treating a depressive episode in patients diagnosed with bipolar depression.

Condition Treatment or Intervention Phase
Bipolar Disorder
 Drug: Quetiapine Fumarate
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:

  • Patients must provide written informed consent prior to any study-specific procedures
  • Patients must be diagnosed with bipolar disorder
  • Patients must currently be experiencing a depressive episode

Exclusion Criteria:

  • Patients must not be pregnant or lactating
  • Patients must not have recent history of substance abuse
  • Patients must not use any medication for their depression or bipolar disorder, other than the study drug, during the study
  • Patients must not have a history of intolerance or lack of response to quetiapine (Seroquel®)

Location and Contact Information

AstraZeneca Information Center (8a-7P EST)      800-236-9933 

Alabama
      Research Site, Birmingham,  Alabama,  United States; Recruiting

Arizona
      Research Site, Scottsdale,  Arizona,  United States; Recruiting

California
      Research Site, Torrance,  California,  United States; Recruiting

      Research Site, Oceanside,  California,  United States; Recruiting

      Research Site, San Diego,  California,  United States; Recruiting

      Research Site, Cerritos,  California,  United States; Recruiting

      Research Site, Garden Grove,  California,  United States; Recruiting

Florida
      Research Site, Orlando,  Florida,  United States; Recruiting

      Research Site, Jacksonville,  Florida,  United States; Recruiting

      Research Site, Leesburg,  Florida,  United States; Recruiting

      Research Site, Winter Park,  Florida,  United States; Recruiting

Idaho
      Research Site, Boise,  Idaho,  United States; Recruiting

Illinois
      Research Site, Oak Brook,  Illinois,  United States; Recruiting

Louisiana
      Research Site, Shreveport,  Louisiana,  United States; Recruiting

Maryland
      Research Site, Baltimore,  Maryland,  United States; Recruiting

New Jersey
      Research Site, Clementon,  New Jersey,  United States; Recruiting

      Research Site, Moorestown,  New Jersey,  United States; Recruiting

New Mexico
      Research Site, Albuquerque,  New Mexico,  United States; Recruiting

New York
      Research Site, Brooklyn,  New York,  United States; Recruiting

      Research Site, Staten Island,  New York,  United States; Recruiting

      Research Site, New York,  New York,  United States; Recruiting

North Carolina
      Research Site, Raleigh,  North Carolina,  United States; Recruiting

Ohio
      Research Site, Cincinnati,  Ohio,  United States; Recruiting

      Research Site, Dayton,  Ohio,  United States; Recruiting

Oklahoma
      Research Site, Oklahoma City,  Oklahoma,  United States; Recruiting

Oregon
      Research Site, Portland,  Oregon,  United States; Recruiting

Pennsylvania
      Research Site, Philadelphia,  Pennsylvania,  United States; Recruiting

      Research Site, Pittsburgh,  Pennsylvania,  United States; Recruiting

South Carolina
      Research Site, Charleston,  South Carolina,  United States; Recruiting

Tennessee
      Research Site, Memphis,  Tennessee,  United States; Recruiting

Texas
      Research Site, Austin,  Texas,  United States; Recruiting

      Research Site, Houston,  Texas,  United States; Recruiting

Utah
      Research Site, Salt Lake City,  Utah,  United States; Recruiting

Virginia
      Research Site, Falls Church,  Virginia,  United States; Recruiting

Washington
      Research Site, Bellevue,  Washington,  United States; Recruiting

      Research Site, Kirkland,  Washington,  United States; Recruiting

      Research Site, Seattle,  Washington,  United States; Recruiting

More Information

Study ID Numbers:  D1447C00135
Record last reviewed:  September 2004
Record first received:  June 3, 2004
ClinicalTrials.gov Identifier:  NCT00083954
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27

Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children and Adolescent Patients with Bipolar I Mania

This study is currently recruiting patients.

Sponsored by: AstraZeneca
Information provided by: AstraZeneca

Purpose

The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania.

Condition Treatment or Intervention Phase
Bipolar Disorder
 Drug: Quetiapine fumarate
Phase III

MedlinePlus related topics:  Bipolar Disorder

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

Eligibility

Ages Eligible for Study:  10 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures
  • Patient has a documented clinical diagnosis of Bipolar I mania
  • Patient’s parent or legal guardian will be able to accompany the patient at each scheduled study visit

Exclusion Criteria:

  • Patients (female) must not be pregnant or lactating
  • Patients with a known intolerance or lack of response to previous treatment with quetiapine
  • Patients who have previously participated in this study

Location and Contact Information

AstraZeneca Information Center (8 AM – 7 PM EST)      1-800-236-9933 

Arizona
      Research Site, Scottsdale,  Arizona,  United States; Not yet recruiting

California
      Research Site, Riverside,  California,  United States; Recruiting

      Research Site, Sacramento,  California,  United States; Not yet recruiting

      Research Site, San Diego,  California,  United States; Not yet recruiting

Colorado
      Research Site, Denver,  Colorado,  United States; Not yet recruiting

Florida
      Research Site, Alamonte,  Florida,  United States; Recruiting

      Research Site, Jacksonville,  Florida,  United States; Recruiting

      Research Site, Miami,  Florida,  United States; Not yet recruiting

Georgia
      Research Site, Augusta,  Georgia,  United States; Not yet recruiting

Illinois
      Research Site, Chicago,  Illinois,  United States; Not yet recruiting

Kansas
      Research Site, Wichita,  Kansas,  United States; Recruiting

Louisiana
      Research Site, New Orleans,  Louisiana,  United States; Not yet recruiting

Missouri
      Research Site, St. Charles,  Missouri,  United States; Recruiting

Nevada
      Research Site, Las Vegas,  Nevada,  United States; Recruiting

New Jersey
      Research Site, Clementon,  New Jersey,  United States; Recruiting

      Research Site, Piscataway,  New Jersey,  United States; Not yet recruiting

New York
      Research Site, Rochester,  New York,  United States; Not yet recruiting

North Carolina
      Research Site, Chapel Hill,  North Carolina,  United States; Not yet recruiting

Ohio
      Research Site, Cincinnati,  Ohio,  United States; Not yet recruiting

      Research Site, Cleveland,  Ohio,  United States; Not yet recruiting

      Research Site, Lyndhurst,  Ohio,  United States; Not yet recruiting

Oklahoma
      Research Site, Oklahoma City,  Oklahoma,  United States; Recruiting

Pennsylvania
      Research Site, Philadelphia,  Pennsylvania,  United States; Not yet recruiting

Tennessee
      Research Site, Madison,  Tennessee,  United States; Recruiting

Texas
      Research Site, Austin,  Texas,  United States; Recruiting

      Research Site, Conroe,  Texas,  United States; Not yet recruiting

      Research Site, Galveston,  Texas,  United States; Not yet recruiting

      Research Site, Houston,  Texas,  United States; Recruiting

      Research Site, San Antonio,  Texas,  United States; Not yet recruiting

Virginia
      Research Site, Richmond,  Virginia,  United States; Recruiting

      Research Site, Virginia Beach,  Virginia,  United States; Recruiting

Washington
      Research Site, Bellevue,  Washington,  United States; Recruiting

      Research Site, Kirkland,  Washington,  United States; Recruiting

      Research Site, Seattle,  Washington,  United States; Not yet recruiting

Wisconsin
      Research Site, Milwaukee,  Wisconsin,  United States; Not yet recruiting

More Information

Study ID Numbers:  D1441C00149
Record last reviewed:  October 2004
Record first received:  August 25, 2004
ClinicalTrials.gov Identifier:  NCT00090311
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27

An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents

This study is currently recruiting patients.

Sponsored by: Abbott Laboratories
Information provided by: Abbott Laboratories

Purpose

The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.

Condition Treatment or Intervention Phase
Bipolar Disorder
 Drug: Divalproex Sodium Extended-Release Tablets
Phase III

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment

Eligibility

Ages Eligible for Study:  10 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

KEY INCLUSION CRITERIA

  • Current primary diagnosis of bipolar I disorder, mania or mixed type
  • Outpatient between 10 and 17 years of age
  • Young Mania Rating Scale score greater than or equal to 20 during screening/washout and at Day 1

KEY EXCLUSION CRITERIA

  • Axis I other than Attention Deficit Hyperactiviy Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder; or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
  • Current manic episode is drug-induced or secondary to a medical disorder (e.g., anti-depressants, hyperthyroidism)
  • Expected to require hospitalization for the current manic episode
  • Participation in psychotherapy that was started within the past 3 months, or if any significant changes are anticipated
  • Has taken atomoxetine or has taken allowed stimulant medication that has not been stable for at least 3 months prior to Day 1, or a dosage adjustment is expected during the study, or that may worsen mood symptoms
  • Unable to swallow tablets
  • Has received depot psychoactive medication within one inter-injection interval of Day 1
  • Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine, barbiturates, benzodiazepines or amphetamines
  • History of alcohol or substance dependence within past 3 mos. or substance abuse within past month
  • History of failed treatment on adequate Depakote (DR or ER) for a manic episode within past 12 months
  • Has taken Depakote (DR or ER) regularly for the current manic episode
  • Has serious violent, homicidal, or suicidal ideation

Location and Contact Information


California
      University of California, Davis, Sacramento,  California,  95817,  United States; Recruiting
Norman Brule  916-734-6770    ndbrule@ucdavis.edu 
Robert Hendren, D.O.,  Principal Investigator

      Stanford University, Stanford,  California,  94304,  United States; Recruiting
Meghan Howe  650-736-2688    meghowe@stanford.edu 
Kiki Chang, M.D.,  Principal Investigator

District of Columbia
      Childrens National Medical Center, Washington,  District of Columbia,  20010,  United States; Recruiting
Karen Seymour  202-884-4261    kseymour@cnmc.org 
Adelaide Robb, M.D.,  Principal Investigator

Florida
      Altamonte Springs,  Florida,  32701,  United States; Recruiting
Brad Sushko, RN  407-830-0414    bsushko@cnsmail.com 
Ali Kashfi, M.D., P.A.,  Principal Investigator

      Destin,  Florida,  32541,  United States; Recruiting
Ron Simkin  850-243-9788    deb62288@aol.com 
Deborah Simkin, M.D., PA,  Principal Investigator

      Professional Clinical Research, Inc., Miami,  Florida,  33161,  United States; Recruiting
Antonio Spears  954-749-9229    aspears@segalinstitute.com 
Sohail Punjwani, MD,  Principal Investigator

Idaho
      Mountain West Clinical Trials, Boise,  Idaho,  83704,  United States; Recruiting
Joe Laragan, RN  208-672-8731    joe@mountainwestclinicaltrials.com 
William T Terry, M.D.,  Principal Investigator

Kansas
      Cientifica Inc at Praire View, Inc., Newton,  Kansas,  67114,  United States; Recruiting
Kendra Frey  316-284-6313    kendra.frey@cientifica.net 
Deborah Bergen, MD,  Principal Investigator

Kentucky
      Lexington,  Kentucky,  40509,  United States; Recruiting
Shannon Broughton  859-264-0045    scb@psychtrials.com 
Michael J Rieser, MD,  Principal Investigator

Louisiana
      LSU - Health Science Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Ann Layman  504-568-7901    alayma@lsuhsc.edu 
Pattie Jarrell  504-599-1128    pjarr1@lsuhsc.edu 
Humberto Quintana, M.D.,  Principal Investigator

      Brentwood Research Institute, Shreveport,  Louisiana,  71101,  United States; Recruiting
Jennifer Swanson  318-227-4565    jen@ brentwoodresearch.com 
Guy Brannon, MD,  Principal Investigator

Missouri
      Mercy Health Research, Chesterfield,  Missouri,  63017,  United States; Recruiting
Jennifer Daech  314-205-0007    daecjl@stlo.mercy.net 
David Duesenberg, M.D.,  Principal Investigator

Texas
      University of Texas Medical Branch, Galveston,  Texas,  77705,  United States; Recruiting
Jennifer Bundens  800-236-2898    jrbunden@utmb.edu 
Karen Wagner, M.D., Ph.D,  Principal Investigator

      University of Texas Medical Branch, Houston,  Texas,  77058,  United States; Recruiting
Nikki Amaratunge, MA  800-236-2898 
Karen Wawner, M.D., Ph.D,  Principal Investigator

More Information

Study ID Numbers:  M01-342
Record last reviewed:  September 2004
Record first received:  August 13, 2003
ClinicalTrials.gov Identifier:  NCT00067262
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27

Child & Adolescent Bipolar Disorder Brain Imaging and Treatment Study

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 National Institute of Mental Health is seeking boys and girls ages 6 to 17 with bipolar disorder who are not doing well on their current medication(s) to participate in a research study. The study includes outpatient assessment, full or partial hospitalization, discontinuation of all current medications, fMRI scanning (a form of brain imaging), and starting new medications at the NIH Clinical Center in Bethesda, MD. No novel or experimental treatments are part of this study. Participants will receive a thorough clinical evaluation.

Participants must be:

In treatment for bipolar disorder with a psychiatrist who agrees that it is appropriate for the child to participate in the study

Psychiatrically unstable on current medications

Able to fill out daily self rating forms and cooperate with study procedures (includes genetics study, MRI, neuropsychological and behavioral testing, and others)

Condition
Healthy

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Natural History

Official Title: The Phenomenology and Neurophysiology of Affective Dysregulation in Children and Adolescents with Bipolar Disorder

Further Study Details: 

Expected Total Enrollment:  700

Study start: August 9, 2000

Bipolar disorder (BPD) in children and adolescents is receiving increased research attention, but important questions remain about its phenomenology and about underlying neural mechanisms. This study has two specific aims: 1) to use longitudinal, objective techniques to characterize the clinical manifestations of early-onset bipolar illness; and 2) to identify behavioral, neuropsychological and neurophysiological correlates of affective dysregulation in bipolar children and adolescents. To accomplish Specific Aim #1, we will obtain prospective clinical data, following patients longitudinally (clinically and with structural MRI scans) for 4 years. In addition, we will assess the psychiatric status of family members, and bank genetic samples from patients and first-degree relatives for use in future studies. To accomplish Specific Aim #2, we will use standardized emotional stimuli to test the hypothesis that responses to negative emotional stimuli are more pronounced in children with BPD than in controls. In addition, we will test the hypotheses that, relative to controls and to children with other psychopathology, children with BPD have distinct deficits in reward systems and in social information processing. Finally, we hypothesize that children who are at risk for BPD will have deficits similar to those exhibited by children with BPD.

Eligibility

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

INCLUSION CRITERIA - Bipolar patients:
Boys and girls must be ages 6-17 and meet DSM-IV criteria for bipolar disorder.
The child must have a primary caregiver who can accompany him or her on trips to NIMH, provide reliable history information, and complete daily rating scales and sleep logs.
Patients must have a psychiatrist who provides clinical care for their BPD.
All youth accepted into the study must be able to complete self-rating forms and to cooperate with other study procedures.
Subjects must be on a stable medication regimen for at least 14 days prior to enrollment in the study. In addition, they, their parents, and treating physician must agree to keep medications stable (with the exception of minor dosage adjustments) until the end of the second NIMH evaluation, if clinically feasible and acceptable. The total duration of the medication-stable period will be approximately six weeks.
INCLUSION CRITERIA - Controls:
Control subjects will be age- and sex-matched to the patients. They will have normal physical and neurological examinations, and an identified primary care physician. Both control subjects and their first-degree relatives must be free of current or past psychopathology.
INCLUSION CRITERIA - Children with ADHD:
Children with ADHD will be: age 7-17, currently meets DSM-IV criteria for ADHD (this will be determined by a K-SADS interview), t score greater than 65 on the Connors Parent scales, and in treatment for the illness with a physician.
INCLUSION CRITERIA - Children with BPD for Discontinuation of Medication with fMRI:
Individuals will meet criteria for BPD, as above. The criteria for treatment failure will be: 1) the child's current CGAS score is less than or equal to 60, and 2) the child's psychiatrist agrees that a change in medication regimen is justified clinically.
INCLUSION CRITERIA - Children at Risk for BPD:
Children age 3-17 with a parent or a sibling diagnosed with BPD.
EXCLUSION CRITERIA - Bipolar Patients:
I.Q. less than 70;
autistic disorder or severe pervasive developmental disorder;
psychosis that interferes with the child's capacity to understand and comply with study procedures.
Unstable medical illness (e.g., severe asthma).
Medical illness that could cause the symptoms of bipolar illness (e.g. multiple sclerosis, thyroid disease).
Pregnancy.
Substance abuse within two months of the initial evaluation.
EXCLUSION CRITERIA - Controls:
I.Q. less than 70.
Ongoing medical illness.
Neurological disorder (including seizures).
Pregnancy.
Past or present substance abuse.
History of sexual abuse.
EXCLUSION CRITERIA - Children with ADHD:
Exclusion criteria will be IQ less than 80; pregnancy; ongoing medical illness or neurological disorder other than ADHD; contraindication to discontinuing medication for 48 hours; contraindication to fMRI scanning; any other psychiatric disorder that is sufficiently severe to require specific treatment, with the exception of oppositional defiant disorder, and the learning, communication, and elimination disorders.
EXCLUSION CRITERIA - Discontinuation of Medication with fMRI:
In addition to exclusion criteria for Bipolar patients, the presence of dental braces or extreme separation anxiety.

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

Geller B, Sun K, Zimerman B, Luby J, Frazier J, Williams M. Complex and rapid-cycling in bipolar children and adolescents: a preliminary study. J Affect Disord. 1995 Aug 18;34(4):259-68.

Wozniak J, Biederman J, Kiely K, Ablon JS, Faraone SV, Mundy E, Mennin D. Mania-like symptoms suggestive of childhood-onset bipolar disorder in clinically referred children. J Am Acad Child Adolesc Psychiatry. 1995 Jul;34(7):867-76.

Faedda GL, Baldessarini RJ, Suppes T, Tondo L, Becker I, Lipschitz DS. Pediatric-onset bipolar disorder: a neglected clinical and public health problem. Harv Rev Psychiatry. 1995 Nov-Dec;3(4):171-95. Review.

Study ID Numbers:  000198; 00-M-0198
Record last reviewed:  August 2, 2004
Last Updated:  August 2, 2004
Record first received:  August 12, 2000
ClinicalTrials.gov Identifier:  NCT00006177
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27

Combination Therapy for the Treatment of Bipolar Disorders

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 determine the effectiveness of a triple drug regimen and a double drug regimen in treating patients with depression, hypomania, or mania.

Condition Treatment or Intervention Phase
Bipolar Disorder
 Drug: Lithium
 Drug: Lamotrigine
 Drug: Divalproex
Phase III

MedlinePlus related topics:  Bipolar Disorder

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

Official Title: Combination Therapy in Bipolar Rapid Cycling

Further Study Details: 

Expected Total Enrollment:  90

Study start: February 2002;  Study completion: January 2005

Early studies have shown lithium to produce a high percentage of satisfactory clinical response in patients with bipolar disorders. These studies, however, do not include lithium-refractory subgroups, such as bipolar II disorder patients. When the wide spectrum of bipolar disorders is considered, the lithium response rate decreases significantly. More broadly effective regimens are needed.

Participants in this study will be randomly assigned to receive either lithium plus divalproex or lithium, divalproex, and lamotrigine for 6 months. Symptoms of depression and mania will be assessed with scales and patient questionnaires.

Eligibility

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Bipolar I or II Disorder
  • Meet criteria for rapid cycling, defined as four or more episodes over the past 12 months
  • Meet criteria for a major depressive episode

Exclusion Criteria:

  • History of intolerability of lithium, divalproex, or lamotrigine

Location and Contact Information


Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting
Renee T. Slembarski  216-844-2864    renee.slembarski@uhhs.com 

Study chairs or principal investigators

Joseph R. Calabrese, MD,  Principal Investigator,  Case Western Reserve University / University Hospitals of Cleveland   

More Information

Study ID Numbers:  62650-01A1
Record last reviewed:  August 2004
Record first received:  June 25, 2003
ClinicalTrials.gov Identifier:  NCT00063362
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27

Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)

This study is currently recruiting patients.

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

Purpose

STEP-BD is the largest treatment study ever conducted for bipolar disorder. It is a long-term outpatient study (5 years) that aims to find out which treatments, or combinations of treatments, are most effective for treating episodes of depression and mania and for preventing recurrent episodes. In addition, the study will evaluate treatment effectiveness in terms of quality of life, adherence to treatment, ability to work, social functioning, and treatment cost-effectiveness. While many treatments are used currently for bipolar disorder, including medications and psychotherapies, doctors are uncertain which of these treatments or combination of treatments actually work best. Findings from STEP-BD will help improve the treatment standards used by doctors in everyday clinical practice.

Condition Treatment or Intervention
Mood Disorders
Affective Disorders, Psychotic
Bipolar Disorder
Cyclothymic Disorder
 Drug: lithium
 Drug: valproate
 Drug: bupropion
 Drug: paroxetine
 Drug: lamotrigine
 Drug: risperidone
 Drug: inositol
 Drug: tranylcypromine
 Behavior: Cognitive Behavioral Therapy
 Behavior: Family-focused Therapy
 Behavior: Interpersonal and Social Rythyms Therapy

MedlinePlus related topics:  Bipolar Disorder;   Mental Health

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

Further Study Details: 

Expected Total Enrollment:  5000

Study start: September 1998;  Study completion: September 2005

STEP-BD is evaluating all the best-practice treatment options used for bipolar disorder: mood-stabilizing medications, antidepressants, atypical antipsychotics, and psychosocial interventions - or "talk" therapies - including Cognitive Behavioral Therapy, Family-focused Therapy, Interpersonal and Social Rhythm Therapy, and Collaborative Care (psychoeducation).

There are two kinds of treatment "pathways" in STEP-BD, and participants may have the opportunity to take part in both. The medications and psychosocial interventions provided in these pathways are considered among the best choices of treatment for bipolar disorder in everyday clinical practice.

In the "Best Practice Pathway," participants are followed by a STEP-BD certified doctor and all treatment choices are individualized. Everyone enrolled in STEP-BD may participate in this pathway. Participants and their doctors work together to decide on the best treatment plans and to change these plans if needed. Also, anyone who wishes to stay on his or her current treatment upon entering STEP-BD may do so in this pathway. Adolescents and adults age 15 years and older may participate in the Best Practice Pathway.

For adults age 18 and older, another way to participate is in the STEP-BD "Randomized Care Pathways." Depending on their symptoms, participants may be offered treatment in one or more of these pathways during the course of the study. The participants remain on mood-stabilizing medication. However, because doctors are uncertain which of several treatment strategies work best for bipolar disorder, another medication and/or talk therapy may be added. Each Randomized Care Pathway involves a different set of these additional treatments.

Unlike in the Best Practice Pathway, the participants in the Randomized Care Pathways are randomly assigned to treatments. Also, in some cases, neither the participant nor the doctor will be told which of the different medications is being added. This is called a "double-blind" study and is done so that the medication effects can be evaluated objectively, without any unintended bias that may come from knowing what has been assigned. Participants will not be assigned medications that they have had bad reactions to in the past, that they are strongly opposed to, or that the doctor feels are unsuitable for them. The medication(s) participants may be randomly assigned to in the Randomized Care Pathways are free of charge. There are other treatment options for participants if they do not respond well to the treatment assigned to them. Also, participants may return to the Best Practice Pathway at any time. About 1,500 individuals will be enrolled in at least one Randomized Care Pathway during their period of participation in STEP-BD.

It is important to note that STEP-BD provides continuity of care. For example, if a participant starts out in the Best Practice Pathway and later chooses to enter one of the Randomized Care Pathways, he or she continues with the same STEP-BD doctor and treatment team. Then, after completing the Randomized Care Pathway, the participant may return to the Best Practice Pathway for ongoing, individually-tailored treatment.

Eligibility

Ages Eligible for Study:  15 Years and above,  Genders Eligible for Study:  Both

Criteria

General Inclusion Criteria:

  • current age 15 or older (Best Practice Pathway) or 18 years or older (Randomized Care Pathways);
  • able to give informed consent for data to be harvested;
  • meet DSM-IV criteria for Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, or Cyclothymic Disorder;
  • undergo a complete standard evaluation including clinical interview, self ratings, and laboratory studies;
  • meet with Clinical Specialist as scheduled;
  • able to complete all Study Registry Forms within 3 months of registration.

General Exclusion Criteria:

  • unwilling or unable to adhere to basic study requirements (i.e., complete rating forms, or attend scheduled evaluations);
  • not competent to give informed consent in the opinion of the investigator (e.g., psychotic).

Participants will be asked to remain in the study for up to five years so that the investigators can document and evaluate long-term treatment outcome. Participants will meet with their STEP-BD psychiatrist for periodic evaluations and/or treatment adjustments during the course of the study, fill out various self-rating forms, and when applicable, participate in psychotherapy. One of the psychotherapy options, Family-Focused Therapy, will require participants and their families to attend counseling sessions together. Overall, the estimated amount of time required from participants in the study is 2 to 4 hours per month.


Location and Contact Information

For more information, call toll-free:      1-866-240-3250    stepbd@mailcity.com
As of October 2004, STEP-BD will be enrolling on a limited basis.    

California
      Stanford University School of Medicine, Stanford,  California,  94305-5723,  United States; Recruiting
Andrea Alarcon  650-498-4801 
Terrence Ketter, M.D.,  Sub-Investigator

Colorado
      University of Colorado, Colorado Psychiatric Health Clinical Investigation Center, Denver,  Colorado,  80220,  United States; Recruiting
Sherri Green  303-315-9645 
Sarah Robertson  303-315-9075 
Michael Allen, M.D.,  Sub-Investigator
Marshall Thomas, M.D.,  Sub-Investigator
David Miklowitz, Ph.D.,  Sub-Investigator

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
Polina Eidelman  617-724-6545 
Andrew A. Nierenberg, M.D.,  Sub-Investigator

      University of Massachusetts Medical Center, Worcester,  Massachusetts,  01655,  United States; Recruiting
Shaughn Maguire  508-856-1741 
Jay Patel, M.D.,  Sub-Investigator

Ohio
      Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; Recruiting
Lisa Frey  216-844-2869 
Joseph R Calabrese, M.D.,  Sub-Investigator

Oklahoma
      University of Oklahoma Health Sciences Center, Tulsa,  Oklahoma,  74129,  United States; Recruiting
Jessica Leon  918-660-3121 
Mark Fossey, M.D.,  Sub-Investigator

Oregon
      Portland Veteran's Administration Medical Center, Portland,  Oregon,  97201,  United States; Recruiting
Robert Socherman, Ph.D.  503-220-8262  Ext. 54522 
Peter Hauser, M.D.,  Sub-Investigator

Pennsylvania
      University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104-2649,  United States; Recruiting
Emily Eisenstein  215-746-6414 
Lazslo Gyulai, M.D.,  Sub-Investigator

      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Judy Callan  412-246-5734 
Michael Thase, M.D.,  Sub-Investigator
Edward Friedman, M.D.,  Sub-Investigator

Texas
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229-3900,  United States; Recruiting
Martha Dahl  210-567-5501 
Charles Bowden, M.D.,  Sub-Investigator

      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
Mood Disorders Center  713-798-6663 
Barbara Kertz  713-798-5693 
Lauren Marangell, M.D.,  Sub-Investigator

Study chairs or principal investigators

Gary Sachs, M.D.,  Principal Investigator,  Massachusetts General Hospital   
Michael Thase, M.D.,  Principal Investigator,  University of Pittsburgh   

More Information

Click here for more information about the study

Study ID Numbers:  N01MH80001
Record last reviewed:  October 2004
Record first received:  March 13, 2001
ClinicalTrials.gov Identifier:  NCT00012558
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27

 

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