Treatment and Outcome of Early Onset Bipolar Disorder
Completed · Phase 4
Conditions studied: Bipolar Disorder
In brief
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.
Key facts
- Study ID
- NCT00048802
- Run by
- Northwell Health
- People needed
- 40
- Starts
- 2002-08-01
- Expected to finish
- 2006-08-01
- Last updated by the study team
- 2014-01-22
Who can join
Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Zucker Hillside Hospital, Long Island Jewish Medical Center — Glen Oaks, New York, United States
Full record on ClinicalTrials.gov
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