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

Completed · Phase 3

Conditions studied: Bipolar Disorder

In brief

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

Key facts

Study ID

NCT00332098

Run by

University of California, Los Angeles

People needed

145

Starts

2006-08-01

Expected to finish

2012-07-01

Last updated by the study team

2014-05-20

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Colorado, Dept. of Psychology — Boulder, Colorado, United States
• Cincinnati Children's Hospital Medical Center/MLC 3014 — Cincinnati, Ohio, United States
• University of Pittsburgh Medical Center Western Psychiatric Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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