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Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00182013
First received: September 14, 2005
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Bipolar Spectrum Disorder
 Drug: Risperidone
Drug: Olanzapine
Drug: Quetiapine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Young Mania Rating Scale [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]
    Improvement defined as score reduction of 30% or greater.


Enrollment: 106
Study Start Date: June 2001
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Risperidone
    Open treatment with Risperidone
    Drug: Olanzapine
    Open treatment with Olanzapine
    Drug: Quetiapine
    Open treatment with Quetiapine
  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182013

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

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00182013     History of Changes
Other Study ID Numbers: 2001P-000259
Study First Received: September 14, 2005
Last Updated: July 19, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Risperidone
Quetiapine
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
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 May 23, 2013