A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar D… (NCT00240721) | Clinical Trial Compass
CompletedPhase 3
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder
363 participantsStarted 2000-10
Plain-language summary
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.
Who can participate
Age range16 Years
SexALL
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Inclusion Criteria:
* Diagnosis of Bipolar I Disorder by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV), and currently experiencing a manic or mixed episode by DSM-IV and Structured Clinical Interview criteria
* experienced at least one previous manic or mixed episode
* Young Mania Rating Scale (YMSR) score \>=20
* physically healthy
* females must be postmenopausal, surgically sterile, or using adequate contraceptive measures, and have a negative pregnancy test.
Exclusion Criteria:
* Diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence) by DSM-IV criteria
* DSM-IV Axis I diagnosis of schizoaffective disorder or impulse control disorder
* experienced a manic episode while taking an antidepressant or psychostimulant drug
* no significant and untreated or unstable medical illness of the liver, kidney, heart, lungs, or endocrine system
* no hypersensitivity to topiramate or have previously participated in a topiramate study.
What they're measuring
1
Change from baseline to Day 21 for the Young Mania Rating Scale (YMRS) total score.
Trial details
NCT IDNCT00240721
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.