CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 145 enrolled
Drug / intervention
Family-Focused Treatment Plus Pharmacotherapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00332098
NCT00332098Phase 3Completed
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Family-Focused Treatment for Bipolar Adolescents

University of California, Los Angeles·interventional·Posted Jun 1, 2006·Updated May 20, 2014

In Brief

A Phase 3 clinical trial evaluating Family-Focused Treatment Plus Pharmacotherapy and Enhanced Care Plus Pharmacotherapy for Bipolar Disorder. Completed, enrolled 145 participants across 3 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 1, 2006
Enrollment StartAug 1, 2006
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 20.1 years ago

Interventions

Family-Focused Treatment Plus Pharmacotherapybehavioral

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.

Enhanced Care Plus Pharmacotherapybehavioral

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.