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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
31
Oral topiramate 300-400mg/day for 12 weeks
Matched placebo to Experimental arm
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Change in Body Mass Index (BMI)
For all participants, BMI was computed using Change in BMI \[kg/m2 (weight/height2)\] over 12 weeks from Baseline to Week 12.
Time frame: 12 weeks
Change in Body Weight
For all participants, change in body weight in kg over 12 weeks from Baseline to Week 12.
Time frame: 12 weeks
Tolerability of Topiramate
Maximum tolerated dosage of topiramate or placebo at end of study participation.
Time frame: 12 weeks
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