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 (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00182013
First received: September 14, 2005
Last updated: June 12, 2013
Last verified: June 2013

September 14, 2005
June 12, 2013
June 2001
February 2004   (final data collection date for primary outcome measure)
Young Mania Rating Scale [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]
Improvement defined as score reduction of 30% or greater.
Not Provided
Complete list of historical versions of study NCT00182013 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Spectrum Disorder
  • Drug: Risperidone
    Open treatment with Risperidone
  • Drug: Olanzapine
    Open treatment with Olanzapine
  • Drug: Quetiapine
    Open treatment with Quetiapine
Not Provided
Joshi G, Petty C, Wozniak J, Faraone SV, Doyle R, Georgiopoulos A, Hammerness P, Walls S, Glaeser B, Brethel K, Yorks D, Biederman J. A prospective open-label trial of quetiapine monotherapy in preschool and school age children with bipolar spectrum disorder. J Affect Disord. 2012 Feb;136(3):1143-53. doi: 10.1016/j.jad.2011.09.042. Epub 2011 Oct 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
Not Provided
February 2004   (final data collection date for primary outcome measure)

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
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00182013
2001P-000259
Not Provided
Joseph Biederman, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Joseph Biederman, MD MGH
Massachusetts General Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP