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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

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Lithium Drug: Olanzapine Drug: Divalproex Drug: Risperidone Drug: Quetiapine Drug: Ziprasidone Drug: Aripriprazole Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Treatment and Outcome of Early Onset Bipolar Disorder
Study Start Date : August 2002
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00048802

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United States, New York
The Zucker Hillside Hospital, Long Island Jewish Medical Center
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Northwell Health
National Institute of Mental Health (NIMH)
Layout table for additonal information Identifier: NCT00048802    
Other Study ID Numbers: R01MH060845 ( U.S. NIH Grant/Contract )
R01MH060845 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2002    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Northwell Health:
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents
Enzyme Inhibitors
Antimanic Agents