Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of family-focused treatment (FFT) plus pharmacotherapy in treating adolescents with bipolar disorder.

Detailed Description
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Bipolar disorder is a serious mental illness that causes drastic shifts in a person's mood, energy, and ability to function. Bipolar disorder can strike at any age, but it most commonly develops in late adolescence or early adulthood. The disorder is characterized by alternating episodes of mania and depression, often with periods of normal mood in between. Some symptoms of a manic episode include the following behaviors: increased energy, activity, and restlessness; excessively high, overly good, euphoric mood; and extreme irritability. In contrast, a depressive episode is characterized by a lasting sad, anxious, or empty mood; feelings of hopelessness or pessimism; and decreased energy. Adolescents with bipolar disorder have high rates of disease recurrence, suicide attempts, functional impairment, and mental health service utilization, even with aggressive treatment with mood stabilizers and antipsychotic drugs. Research has suggested that FFT, a behavioral intervention consisting of psychoeducation, communication training, and problem solving training, may lead to improvements in mood symptoms in adolescents with bipolar disorder. This study will evaluate the effectiveness of FFT plus pharmacotherapy in treating adolescents with bipolar illness. Participants in this 2-year, single-blind study will be randomly assigned to receive a combination of either FFT and pharmacotherapy or enhanced care and pharmacotherapy. Medications used for the pharmacotherapy portion of the study will include mood stabilizers, such as lithium or divalproex sodium, and atypical antipsychotics, such as quetiapine. Participants will also receive anti-anxiety medications, psychostimulants, or antidepressants as needed. All participants will receive pharmacotherapy for the full 2 years. Participants assigned to enhanced care will take part in weekly brief psychoeducation sessions for 3 weeks. Participants assigned to FFT will take part in weekly treatment sessions with their families for 12 weeks, biweekly for 12 weeks, monthly for 3 months, and then trimonthly until Month 24. Both FFT and enhanced care treatment sessions will include psychoeducation focusing on appropriate ways to manage bipolar disorder and its cycling nature. Crisis intervention sessions will also be offered to all participants on an as-needed basis for the duration of the study. Outcomes, including bipolar disorder symptoms, functioning, and service utilization, will be measured at study visits at Months 3, 6, 9, 12, 18, and 24.

Official Title
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Family-Focused Treatment for Bipolar Adolescents

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Behavioral: Family-Focused Treatment Plus Pharmacotherapy
* Behavioral: Enhanced Care Plus Pharmacotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 13 years, 0 months and 17 years, 11 months Meets The Diagnostic and Statistical Manual of Mental Disorders - IV criteria for either of the following conditions: bipolar I or bipolar II disorder with a manic, mixed, or hypomanic episode within 3 months of study entry; or a depressed episode within 3 months of study entry with a prior history of a manic, hypomanic, or mixed episode (if the participant only meets criteria for a current hypomanic episode, there must also be a history of at least one prior depressive, manic, or mixed episode) Has experienced severe depression, hypomania, or mania symptoms for a period of at least 1 week within the 3 months prior to study entry Lives with at least one biological or step-parent who is available and willing to participate in treatment (parents not currently living with the adolescent participant may also participate) Exclusion Criteria: Currently in full recovery (experienced minimal symptoms for at least 8 continuous weeks) Meets Diagnostic and Statistical Manual of Mental Disorders, IV criteria for substance abuse disorder or substance dependence disorder within 3 months of study entry (based on the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version ) Meets current criteria for bipolar, not otherwise specified, or substance-induced mood disorder Diagnosis of mental retardation, autism, or organic central nervous system disorder Severe, unremitting psychosis that is unresponsive to neuroleptic medications, and has lasted more than 3 months Requires extended inpatient treatment (although participant can be hospitalized at the time of intake into the study) Current life-threatening eating disorder, neurological condition, or other medical problem that requires immediate treatment Exhibits or expresses serious homicidal tendencies Victim of current sexual or physical abuse by parents or is in an environment marked by domestic violence among the parents or step-parents

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Family-Focused Treatment Plus Pharmacotherapy | Behavioral: Family-Focused Treatment Plus Pharmacotherapy<br>* Participants assigned to FFT will take part in weekly treatment sessions with their families for 12 weeks, biweekly for 12 weeks, monthly for 3 months, and then trimonthly until Month 24. Medications used for the pharmacotherapy portion of the study will include mood stabilizers, such as lithium or divalproex sodium, and atypical antipsychotics, such as quetiapine. Participants will also receive anti-anxiety medications, psychostimulants, or antidepressants as needed.<br>|
| Active Comparator: 2<br>Enhanced Care Plus Pharmacotherapy | Behavioral: Enhanced Care Plus Pharmacotherapy<br>* Participants assigned to Enhanced Care will take part in weekly brief psychoeducation sessions for 3 weeks. The pharmacotherapy treatment will be the same as for the FFT participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery |  | Measured at Month 24 | 
| Time to recurrence |  | Measured at Month 24 | 
| Severity of manic and depressive symptoms |  | Measured at Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functioning |  | Measured at Month 24 | 
| Quality of life |  | Measured at Month 24 | 
| Service utilization |  | Measured at Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childhood Mood Disorders, Family Treatment, Psychoeducation, Pharmacotherapy, Family Functioning, Psychosocial Intervention