Bipolar Spectrum Disorder
Conditions
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.
Interventions
DRUGRisperidone
Open treatment with Risperidone
DRUGOlanzapine
Open treatment with Olanzapine
DRUGQuetiapine
Open treatment with Quetiapine
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Young Mania Rating Scale | baseline to 8 weeks | Improvement defined as score reduction of 30% or greater. |
Outcome results
None listed