Status:
COMPLETED
Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Eligibility:
All Genders
13-17 years
Phase:
PHASE3
Brief Summary
This study will evaluate the effectiveness of family-focused treatment (FFT) plus pharmacotherapy in treating adolescents with bipolar disorder.
Detailed Description
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 la...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00332098
Start Date
August 1 2006
End Date
July 1 2012
Last Update
May 20 2014
Active Locations (3)
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1
University of Colorado, Dept. of Psychology
Boulder, Colorado, United States, 80309-0345
2
Cincinnati Children's Hospital Medical Center/MLC 3014
Cincinnati, Ohio, United States, 45229
3
University of Pittsburgh Medical Center Western Psychiatric Institute
Pittsburgh, Pennsylvania, United States, 15213