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

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.

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

Criteria

Inclusion Criteria:

• Bipolar II Depression

Pennsylvania
      Depression Research Unit, Univ Penn, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting

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

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

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.

California
      Study Site (014), Los Angeles,  California,  90048,  United States; No longer recruiting
      Beverly Hills,  California,  90210,  United States; Recruiting
      San Diego,  California,  92108,  United States; Recruiting
      Santa Ana,  California,  92705,  United States; Recruiting
Georgia
      Marietta,  Georgia,  30060,  United States; Recruiting
Indiana
      Terre Haute,  Indiana,  47802,  United States; Recruiting
Kentucky
      Study Site (011), Florence,  Kentucky,  41042,  United States; Terminated
Louisiana
      Shreveport,  Louisiana,  71101,  United States; Not yet recruiting
New Jersey
      Clementon,  New Jersey,  08021,  United States; Recruiting
      Princeton,  New Jersey,  08540,  United States; Recruiting
New York
      New York,  New York,  10021,  United States; Recruiting
      Bronx,  New York,  10467,  United States; Recruiting
North Carolina
      Raleigh,  North Carolina,  27609,  United States; Recruiting
Ohio
      Study Site (004), Cleveland,  Ohio,  44016,  United States; Terminated
      Beachwood,  Ohio,  44122,  United States; Not yet recruiting
Oregon
      Portland,  Oregon,  97210,  United States; Recruiting
      Eugene,  Oregon,  97401,  United States; Recruiting
South Carolina
      Columbia,  South Carolina,  29201,  United States; Recruiting
Texas
      Houston,  Texas,  77058,  United States; Recruiting
      Study Site (008), Houston,  Texas,  77090,  United States; Recruiting
      Galveston,  Texas,  77555,  United States; Recruiting

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

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

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

Arkansas
      Pinnacle Pointe Hospital, Little Rock,  Arkansas,  72211,  United States; Recruiting
California
      Cedars Sinai Mediacl Center, Los Angeles,  California,  90048,  United States; Recruiting
Florida
      Ted Broeck Hospital, Jacksonville,  Florida,  32216,  United States; Recruiting
      Segal Institute for Clinical Research, North Miami,  Florida,  33161,  United States; Recruiting
Georgia
      CRCA, Stone Mountain,  Georgia,  300087,  United States; Recruiting
Louisiana
      Institution for Neuropsychiatry, Lake Charles,  Louisiana,  70601,  United States; Recruiting
      LSU Health Sciences Center, Shreveport,  Louisiana,  14760,  United States; Recruiting
Massachusetts
      Children's Hospital of Boston, Boston,  Massachusetts,  02115,  United States; Recruiting
Missouri
      Mercy Medical Group, St. Louis,  Missouri,  63017,  United States; Recruiting
      Millennium Psychiatric Associates, St. Louis,  Missouri,  63044,  United States; Recruiting
New York
      Global Research and Consulting, Olean,  New York,  14760,  United States; Recruiting
      University at Stony Brook, Stony Brook,  New York,  11794,  United States; Recruiting
Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting
      Psychiatric Professional Services, Cincinnati,  Ohio,  45267,  United States; Recruiting
Oklahoma
      Cutting Edge Research Group, Oklahoma City,  Oklahoma,  73120,  United States; Recruiting
Texas
      MedLabs Research of Houston, Houston,  Texas,  77057,  United States; Recruiting
      University of Texas Medical Branch, Galveston,  Texas,  77555,  United States; Recruiting
Utah
      University of Utah, Salt Lake City,  Utah,  84132,  United States; Recruiting
Virginia
      Centers for Behavioral Health at Maryview, Portsmouth,  Virginia,  23703,  United States; Recruiting
      Virginia Treatment Center for Children, Richmond,  Virginia,  23298,  United States; Recruiting

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

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

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®)

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

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

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

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

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

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

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

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

California
      University of California, Davis, Sacramento,  California,  95817,  United States; Recruiting
      Stanford University, Stanford,  California,  94304,  United States; Recruiting
District of Columbia
      Childrens National Medical Center, Washington,  District of Columbia,  20010,  United States; Recruiting
Florida
      Altamonte Springs,  Florida,  32701,  United States; Recruiting
      Destin,  Florida,  32541,  United States; Recruiting
      Professional Clinical Research, Inc., Miami,  Florida,  33161,  United States; Recruiting
Idaho
      Mountain West Clinical Trials, Boise,  Idaho,  83704,  United States; Recruiting
Kansas
      Cientifica Inc at Praire View, Inc., Newton,  Kansas,  67114,  United States; Recruiting
Kentucky
      Lexington,  Kentucky,  40509,  United States; Recruiting
Louisiana
      LSU - Health Science Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
      Brentwood Research Institute, Shreveport,  Louisiana,  71101,  United States; Recruiting
Missouri
      Mercy Health Research, Chesterfield,  Missouri,  63017,  United States; Recruiting
Texas
      University of Texas Medical Branch, Galveston,  Texas,  77705,  United States; Recruiting
      University of Texas Medical Branch, Houston,  Texas,  77058,  United States; Recruiting

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

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

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.

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.

Maryland
      National Institute of Mental Health (NIMH), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

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

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

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.

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

Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting

Study chairs or principal investigators

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

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

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

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.

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.

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
Colorado
      University of Colorado, Colorado Psychiatric Health Clinical Investigation Center, Denver,  Colorado,  80220,  United States; Recruiting
Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
      University of Massachusetts Medical Center, Worcester,  Massachusetts,  01655,  United States; Recruiting
Ohio
      Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; Recruiting
Oklahoma
      University of Oklahoma Health Sciences Center, Tulsa,  Oklahoma,  74129,  United States; Recruiting
Oregon
      Portland Veteran's Administration Medical Center, Portland,  Oregon,  97201,  United States; Recruiting
Pennsylvania
      University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104-2649,  United States; Recruiting
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Texas
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229-3900,  United States; Recruiting
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting

Study chairs or principal investigators

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

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