Treatment and Outcome of Early Onset Bipolar Disorder

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Olanzapine; Quetiapine Fumarate; Risperidone; Valproic Acid; Ziprasidone

Criteria

Inclusion criteria:

• Have a diagnosis of Bipolar I Disorder;

• Have had aggressive and/or psychotic features (delusions, hallucinations and/or thought disorder) during the most recent manic episode;

• Is willing to be treated or is already being treated with the combination of mood stabilizer(s) (lithium or Depakote) and an atypical antipsychotic medication (Abilify, Geodon, Risperdal, Seroquel, or Zyprexa);

• Live in the NY Metropolitan area;

• Able to attend weekly to biweekly office visits

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