A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatme⦠(NCT00035802) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder
13 participantsStarted 2002-01
Plain-language summary
The purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder.
Who can participate
Age range13 Years ā 17 Years
SexALL
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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 currenā¦
What they're measuring
1
Change from baseline in total Young Mania Rating Scale (YMRS) score
Timeframe: Baseline to Day 28 (or last available observation prior to Day 28).
Trial details
NCT IDNCT00035802
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.