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A study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder. Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder. conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder. Clinical research trials and A study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder. medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder.. A study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder. Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder. clinical trial. Test subjects typically obtain the finest healthcare available for their A study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder. condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.

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A study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder.



A study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder.

For Condition: Bipolar Disorder
Status: Terminated
Sponsor(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ,
Synopsis: A 4-week study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder with an optional 6-month open-label extension for qualified patients following completion of the study.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/17 Years
Genders: Both
Protocol Entry Criteria: - DSM-IV diagnosis of Bipolar I Disorder (confirmed by 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 - Subject's parent or guardian must be fully capable of monitoring the subject'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 subjects
Total Enrollment: 

Location and Contact Information:


Additional Information:
Study ID Numbers:
  TOPMAT-PDMD-009; 
Study Start Date: 
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035802

Other Bipolar Disorder Studies:
1. Olanzapine Versus Placebo in the Treatment of Mania in Adolescents with Bipolar I Disorder

2. Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)

3. An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder

4. Clinical Trial of Pramipexole in Bipolar Depression

5. Study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents

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