A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder
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ClinicalTrials.gov Identifier: NCT00037674 |
Recruitment Status
:
Completed
First Posted
: May 21, 2002
Last Update Posted
: May 18, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar Disorder | Drug: Topiramate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 434 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Multicenter, Placebo-Controlled 12-Week Study of the Safety and Efficacy of Two Doses of Topiramate for the Treatment of Acute Manic or Mixed Episodes in Patients With Bipolar I Disorder With an Optional Open-Label Extension |
Study Start Date : | January 2001 |
Actual Study Completion Date : | May 2003 |

- Change from baseline to Day 21 in the total Young Mania Rating Scale (YMRS) score.
- Change from baseline to Day 21 and Week 12 in scores of MADRS, BPRS, CGI, and GAS. Response to treatment, indicated by no longer meeting DSM-IV criteria for manic/mixed episode. Incidence of adverse events monitored throughout the study.

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of Bipolar I Disorder by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I
- )
- At least one previous manic or mixed episode
- Meeting minimum severity criteria (a Young Mania Rating Scale [YMRS] score of >=20 at screening and baseline visits) for the current acute manic or mixed episode
- Females must be postmenopausal, surgically sterile, or using adequate contraceptive measures, and have a negative pregnancy test
Exclusion Criteria:
- DSM-IV diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence)
- DSM-IV Axis I diagnosis of schizoaffective disorder or impulse control disorder
- Experienced a manic episode while taking an antidepressant or psychostimulant drug
- Known hypersensitivity to topiramate or previously participated in a topiramate study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037674
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00037674 History of Changes |
Other Study ID Numbers: |
CR003199 |
First Posted: | May 21, 2002 Key Record Dates |
Last Update Posted: | May 18, 2011 |
Last Verified: | January 2011 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Bipolar Disorder Bipolar Mania Topiramate Lithium |
Additional relevant MeSH terms:
Disease Bipolar Disorder Pathologic Processes Bipolar and Related Disorders Mental Disorders Topiramate |
Anticonvulsants Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |