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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00332098 |
This study will evaluate the effectiveness of family-focused treatment (FFT) plus pharmacotherapy in treating adolescents with bipolar disorder.
Condition | Intervention | Phase |
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Bipolar Disorder |
Behavioral: Family-Focused Treatment Plus Pharmacotherapy Behavioral: Enhanced Care Plus Pharmacotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Family-Focused Treatment for Bipolar Adolescents |
Estimated Enrollment: | 150 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Family-Focused Treatment Plus Pharmacotherapy
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Behavioral: Family-Focused Treatment Plus Pharmacotherapy
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.
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2: Active Comparator
Enhanced Care Plus Pharmacotherapy
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Behavioral: Enhanced Care Plus Pharmacotherapy
Participants assigned to EC will take part in weekly brief psychoeducation sessions for 3 weeks. The pharmacotherapy treatment will be the same as for the FTT participants.
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Bipolar disorder (BPD) is a serious mental illness that causes drastic shifts in a person's mood, energy, and ability to function. BPD 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 BPD 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 BPD symptoms in adolescents. This study will evaluate the effectiveness of FFT plus pharmacotherapy in treating adolescents with BPD.
Participants in this 2-year, single-blind study will be randomly assigned to receive a combination of either FFT and pharmacotherapy or enhanced care (EC) 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 EC 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 EC treatment sessions will include psychoeducation focusing on appropriate ways to manage BPD 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 BPD symptoms, functioning, and service utilization, will be measured at study visits at Months 3, 6, 9, 12, 18, and 24.
Ages Eligible for Study: | 13 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David J. Miklowitz, PhD | 303-492-8575 | miklow@psych.colorado.edu |
Contact: Elizabeth L. George, PhD | 303-207-1161 | egeorge@colorado.edu |
United States, Colorado | |
University of Colorado, Dept. of Psychology | Recruiting |
Boulder, Colorado, United States, 80309-0345 | |
Contact: David J. Miklowitz, PhD 303-492-8575 miklow@psych.colorado.edu | |
Contact: Elizabeth L. George, PhD 303-207-1161 egeorge@colorado.edu | |
Principal Investigator: David J. Miklowitz, PhD | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center/University of Cincinnati Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45267-0559 | |
Contact: Robert A. Kowatch, MD 513-636-0024 robert.kowatch@cchmc.org | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center Western Psychiatric Institute | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: David A. Axelson, MD 412-246-5770 axelsonda@upmc.edu |
Principal Investigator: | David J. Miklowitz, PhD | University of Colorado at Boulder |
Principal Investigator: | Robert A. Kowatch, MD | University of Cincinnati |
Principal Investigator: | David A. Axelson, MD | University of Pittsburgh |
Responsible Party: | University of Colorado, Dept. of Psychology ( David J. Miklowitz, PhD ) |
Study ID Numbers: | R01 MH73871, R01 MH73817, R01 MH74033, DSIR 84-CTS |
Study First Received: | May 30, 2006 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00332098 |
Health Authority: | United States: Federal Government |
Childhood Mood Disorders Family Treatment Psychoeducation |
Pharmacotherapy Family Functioning Psychosocial Intervention |
Quetiapine Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Mood Disorders |
Lithium Carbonate Psychotic Disorders Valproic Acid Lithium |
Pathologic Processes Disease |