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

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Bipolar Spectrum Disorder

Treatments

Drug: Risperidone

Drug: Quetiapine

Drug: Olanzapine

Study type

Interventional

Funder types

Other

Identifiers

NCT00182013

2001P-000259

Details and patient eligibility

About

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.

Enrollment

106 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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