Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine

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.
• Manic or mixed episode due to a general medical condition or substance-induced mania (DSM-IV-TR).
• Mental retardation (IQ 3).
• Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.
• Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants.
• Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
• Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified.