A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder
Bipolar Disorder, Affective Disorders, Psychotic, Mood Disorders
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar, Mania, Pediatric, Children, Adolescent, Topiramate, Anticonvulsants, Central Nervous System Agents, Protective Agents, Neuroprotectiive Agents
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of Bipolar I Disorder (confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version [K-SADS-P/L]) YMRS score greater than or equal to 20 General good health as determined by medical history, physical examination, and laboratory evaluations Ability to swallow tablets Patient's parent or guardian must be fully capable of monitoring the patient's disease process and compliance to treatment Parent(s) or legal guardian(s) must read and sign the informed consent form after the nature of the study has been fully explained and assent must be obtained from patients Exclusion Criteria: DSM-IV Axis I disorder diagnoses of autistic disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders not otherwise specified (NOS) DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within the 3 months prior to baseline. Acute or intermittent substance abuse prior to screening will not be exclusionary, depending upon the clinical judgment of the investigator Chronic antidepressant treatment within 4 weeks of randomization (5 weeks for fluoxetine), use of psychostimulants in the 7 days prior to baseline, use of any other psychotropic medications within 3 days or 5 half-lives, whichever is less, prior to baseline, or requirement for treatment with other psychotropic drugs on an ongoing basis Weight less than 33 kg or current or past history of anorexia nervosa Serious or unstable medical or neurological conditions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
001
002
Topiramate Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days. OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.
Placebo Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.