Conditions: Bipolar Disorder Weight Gain
Keywords: Bipolar Disorder Weight Gain
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 31
Healthy volunteers: no

Brief summary:
The primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder. The secondary objective is to examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.

Detailed description:
After consent and screening, patients will be initiated on 5mg or 10mg per day of olanzapine. Olanzapine doses will be titrated to 10-20 mg of olanzapine over one week, to a maximum of 20mg by day 21. Patients will also receive either topiramate (25mg bid titrated over 18 days to 150 mg bid. with flexibility to titrate to 200mg bid) or matched placebo. Topiramate will be initiated at a dose of 25 mg bid and will be increased by 25 mg bid every three days as tolerated. Patients will be evaluated by a blinded (to treatment status and adverse events) rater.

Arms:
arm 1: Patients' initial dose of topiramate 25mg bid, which was titrated over 18 days to 150 mg bid (with flexibility to titrate to 200mg bid) as tolerated. arm 2: Sugar pill

Interventions: intervention 1: Topiramate intervention 2: Placebo
Intervention descriptions: intervention 1: Oral topiramate 300-400mg/day for 12 weeks intervention 2: Matched placebo to Experimental arm

Protocol document: