Treatment and Outcome of Early Onset Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00048802
Recruitment Status : Completed
First Posted : November 13, 2002
Last Update Posted : January 22, 2014
National Institute of Mental Health (NIMH)
Information provided by:
Northwell Health

November 8, 2002
November 13, 2002
January 22, 2014
August 2002
August 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00048802 on Archive Site
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Treatment and Outcome of Early Onset Bipolar Disorder
Treatment and Outcome of Early Onset Bipolar Disorder
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Lithium
  • Drug: Olanzapine
  • Drug: Divalproex
  • Drug: Risperidone
  • Drug: Quetiapine
  • Drug: Ziprasidone
  • Drug: Aripriprazole
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2006
August 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH060845( U.S. NIH Grant/Contract )
R01MH060845 ( U.S. NIH Grant/Contract )
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Northwell Health
National Institute of Mental Health (NIMH)
Not Provided
Northwell Health
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP