Bipolar Disorder Clinical Trial
Official title:
Treatment and Outcome of Early Onset Bipolar Disorder
This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.
In children and adolescents, bipolar disorder is often accompanied by symptoms such as
hallucinations, delusions, or paranoia that require acute treatment with a combination of an
atypical antipsychotic medication and a mood stabilizer. It is not known if it is necessary
to continue treatment with the atypical antipsychotic medication after the child's symptoms
have remitted.
Participants in this study are treated with lithium, divalproex (Depakote), and one of the
following atypical antipsychotic medications: olanzapine (Zyprexa), risperidone (Risperdal)
or quetiapine (Seroquel) for at least 24 weeks. Participants who have already begun
combination therapy with at least one of the mood stabilizers and atypical antipsychotic
medications listed above are also encouraged to enroll in this study. After participants
have been on combination therapy for at least 24 weeks they will then be randomly assigned
to one of two groups. The first group will continue to receive active mood stabilizer and
atypical antipsychotic medication. The second group will receive active mood stabilizer and
placebo. Participants are assessed weekly and followed for up to 18 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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