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Treatment and Outcome of Early Onset Bipolar Disorder - Article


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Olanzapine Injection

Zyprexa Injection


Clinical Trial: Treatment and Outcome of Early Onset Bipolar Disorder

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

This study aims to enroll children and adolescents between the ages of 10 to 18 years old who have bipolar I disorder with aggressive and/or psychotic features. The purpose of this study is to assess if continuing antipsychotic medication after at least six months of combination treatment with a mood stabilizer and antipsychotic medication is necessary after the psychotic features or aggressive behavior have resolved.

Condition Treatment or Intervention Phase
Bipolar Disorder
 Drug: Lithium
 Drug: Olanzapine
 Drug: Divalproex
 Drug: Risperidone
 Drug: Quetiapine
 Drug: Ziprasidone
 Drug: Aripriprazole
Phase IV

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  80

Study start: August 2002;  Expected completion: August 2007

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 or divalproex (Depakote)and one of the following atypical antipsychotic medications: olanzapine (Zyprexa), risperidone (Risperdal), quetiapine (Seroquel), ziprasidone (Geodon) or aripriprazole (Abilify) 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.

Eligibility

Ages Eligible for Study:  10 Years   -   18 Years,  Genders Eligible for Study:  Both

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

Location and Contact Information


New York
      The Zucker Hillside Hospital, Long Island Jewish Medical Center, Glen Oaks,  New York,  11004,  United States; Recruiting
Alison Berest, BS  718-470-8444    aberest@lij.edu 
Vivian Kafantaris, MD,  Principal Investigator

More Information

Publications

Kafantaris V, Coletti DJ, Dicker R, Padula G, Kane JM. Adjunctive antipsychotic treatment of adolescents with bipolar psychosis. J Am Acad Child Adolesc Psychiatry. 2001 Dec;40(12):1448-56.

Kafantaris V. Treatment of bipolar disorder in children and adolescents. J Am Acad Child Adolesc Psychiatry. 1995 Jun;34(6):732-41. Review.

Kafantaris V, Coletti DJ, Dicker R, Padula G, Kane JM. Lithium treatment of acute mania in adolescents: a large open trial. J Am Acad Child Adolesc Psychiatry. 2003 Sep;42(9):1038-45.

Study ID Numbers:  60845-01A1
Record last reviewed:  November 2004
Last Updated:  November 12, 2004
Record first received:  November 8, 2002
ClinicalTrials.gov Identifier:  NCT00048802
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 12, 2008



Page Updated: June 1, 2005
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