Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II 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: NCT00182013
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 13, 2013
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Brief Summary:
The objective of this study is to compare the safety and effectiveness of Risperidone, Olanzapine, and Quetiapine in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks and then over an extension phase. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study.

Condition or disease Intervention/treatment Phase
Bipolar Spectrum Disorder Drug: Risperidone Drug: Olanzapine Drug: Quetiapine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2001
Actual Primary Completion Date : February 2004

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Risperidone
    Open treatment with Risperidone
  • Drug: Olanzapine
    Open treatment with Olanzapine
  • Drug: Quetiapine
    Open treatment with Quetiapine

Primary Outcome Measures :
  1. Young Mania Rating Scale [ Time Frame: baseline to 8 weeks ]
    Improvement defined as score reduction of 30% or greater.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females age 6 to 18 years of age
  • Patient must have a diagnosis of bipolar I or bipolar II disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders).
  • Patients must have an initial score on the Y-MRS total score of at least 15.
  • Patient must be able to participate in mandatory blood draws.
  • Patient must be able to swallow pills.

Exclusion Criteria:

  • Patients with chronic medical illness, DSM-IV substance dependence within the past 6 months, pregnant or nursing females, and those at serious risk of suicide will be excluded from the study

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): NCT00182013

Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Joseph Biederman, MD MGH

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Joseph Biederman, MD, Principal Investigator, Massachusetts General Hospital Identifier: NCT00182013     History of Changes
Other Study ID Numbers: 2001P-000259
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
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