Treatment and Outcome of Early Onset Bipolar Disorder

Phase 4

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00048802
• Lead Sponsor: Northwell Health

Brief Summary

This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.

Detailed Description

In children and adolescents, bipolar disorder is often accompanied by symptoms such as hallucinations, delusions, or paranoia that require acute treatment with a combination of an atypical antipsychotic medication and a mood stabilizer. It is not known if it is necessary to continue treatment with the atypical antipsychotic medication after the child's symptoms have remitted.

Participants in this study are treated with lithium, divalproex (Depakote), and one of the following atypical antipsychotic medications: olanzapine (Zyprexa), risperidone (Risperdal) or quetiapine (Seroquel) for at least 24 weeks. Participants who have already begun combination therapy with at least one of the mood stabilizers and atypical antipsychotic medications listed above are also encouraged to enroll in this study. After participants have been on combination therapy for at least 24 weeks they will then be randomly assigned to one of two groups. The first group will continue to receive active mood stabilizer and atypical antipsychotic medication. The second group will receive active mood stabilizer and placebo. Participants are assessed weekly and followed for up to 18 months.

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2002-11-08
• Study First Submitted QC: 2002-11-12
• Study First Posted: 2002-11-13
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

• Medical contraindication to treatment with lithium and divalproex
• Seizure disorder
• Pregnancy
• Unwillingness to use acceptable methods of birth control if sexually active
• IQ less than 70
• Substance-induced mood disorder or mood disorder due to a general medical condition
• Prior experience with re-emergence of psychotic features or severe aggression within 6 months of antipsychotic medication discontinuation under circumstances similar to those in the study
• Potentially lethal suicide attempts or infliction of serious injury upon someone during most severe bipolar episode
• High risk for running away or truancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

The Zucker Hillside Hospital, Long Island Jewish Medical Center; 🇺🇸 Glen Oaks, New York, United States