Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine (NCT00394095) | Clinical Trial Compass
CompletedPhase 4
Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine
United States31 participantsStarted 2006-12
Plain-language 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.
Who can participate
Age range10 Years – 18 Years
SexALL
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Inclusion criteria
✓. Male or female patients, ages 10-18 years.
✓. Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
✓. Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation.
✓. Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) bipolar disorder, type I and currently display an acute manic or mixed episode as determined by K-SADS (Geller et al 2000).
✓. Patients must have a baseline (day 0) Young Mania Rating Scale score of at least 16.
✓. Subjects should be fluent in English.
Exclusion criteria
✕. Female patients who are either pregnant or lactating.
✕. Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions.
✕. Any history of current or past diabetes that has been treated with pharmacological intervention.
✕. Neurological disorders including epilepsy, stroke, or severe head trauma.
✕. Clinically significant laboratory abnormalities (\> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices. Clinically abnormal ECG.