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

Bipolar Spectrum Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182013
• Other study ID #: 2001P-000259
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: June 12, 2013
• Start date: June 2001

Study information

• Verified date: June 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Spectrum Disorder

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Young Mania Rating Scale	Improvement defined as score reduction of 30% or greater.	baseline to 8 weeks	No