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



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

For Condition: Bipolar Disorder
Status: Completed
Sponsor(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ,
Synopsis: This is a 12-week study to evaluate the safety and effectiveness of topiramate to carbolithium or placebo in the treatment if Bipolar I Disorder. An optional 6-month open-label extension is available for qualified patients following completion of the study.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: The subjects will be male or female, 18 years of age or older with a diagnosis of Bipolar I Disorder confirmed by the SCID-I, who have had at least one previous manic or mixed episode. The subjects will meet minimum severity criteria (a YMRS score of 20 or greater at screening and baseline visits) for the current acute manic or mixed episode.
Total Enrollment: 

Location and Contact Information:

Psychiatric Centre Janta Colony
Jaipur,  Rajasthan,  302 004
India
 

Kasturba Hospital
Manipal,  Karnataka,  576 119
India
 

King George Medical College & Ghandi Memorial and Associated Hospitals
Lucknow,  Uttar Pradesh,  226 003
India
 

Vidyasagar Institute of Mental Health and Neuro Sciences
New Dehli,  Nehru Nagar,  110 065
India
 


Additional Information:
Study ID Numbers:
  PRI/TOP-INT-40 (PDMD-004); 
Study Start Date: May 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037674

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4. The Assessment of a weight-gain agent for the Treatment of Olanzapine-Associated Anti-obesity Agent in Patients with Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder

5. Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

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