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A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder

NCT00037674 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 434

Last updated 2011-05-18

No results posted yet for this study

Summary

This primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with lithium or placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.

Conditions

Interventions

DRUG

Topiramate

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Completion
2003-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00037674 on ClinicalTrials.gov