A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder

NCT00240721 | Completed Phase 3

• 1 other identifier: CR002248
• Study Type: interventional
• Target: 363
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bipolar Disorders; Mood Disorders; Affective Disorders, Psychotic

Keywords

topiramate; bipolar disorders; mood disorders; manic state; depression; manic-depressive psychoses

Outcome Measures

Primary Outcomes (1)

• Change from baseline to Day 21 for the Young Mania Rating Scale (YMRS) total score.

Secondary Outcomes (1)

• Change from baseline to Day 21 for scores on MADRS, BPRS, CGI, and GAS; response to treatment, indicated by not any longer meeting DSM-IV criteria for manic/mixed episode.

Interventions

topiramate DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Links

• A study of the effectiveness and safety of topiramate in the treatment of patients with Bipolar Disorder

MeSH Terms

Conditions

Bipolar Disorder; Mood Disorders; Affective Disorders, Psychotic; Mania; Depression

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: October 1, 2000
• Study Completion: September 1, 2002
• Last Updated: June 8, 2011

Record last verified: 2010-11