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Treatment and Outcome of Early Onset Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00048802
First received: November 8, 2002
Last updated: August 20, 2008
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
 Drug: Lithium
Drug: Olanzapine
Drug: Divalproex
Drug: Risperidone
Drug: Quetiapine
Drug: Ziprasidone
Drug: Aripriprazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment and Outcome of Early Onset Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 40
Study Start Date: August 2002
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048802

Locations
United States, New York
The Zucker Hillside Hospital, Long Island Jewish Medical Center
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00048802     History of Changes
Other Study ID Numbers: R01 MH60845, DSIR 84-CTM
Study First Received: November 8, 2002
Last Updated: August 20, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Adolescence

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lithium
Risperidone
Quetiapine
Olanzapine
Ziprasidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 18, 2013