NCT00035230

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2001

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2002

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
Last Updated

June 8, 2011

Status Verified

January 1, 2011

First QC Date

May 2, 2002

Last Update Submit

June 6, 2011

Conditions

Bipolar Disorder

Keywords

Bipolar disordersBipolarmaniaTopiramateLithium

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Changes from baseline to Day 21 and Week 12 in the scores of CGI, MADRS, BPRS, 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.

Interventions

TopiramateDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (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) confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I
  • Currently in a manic or mixed episode and at least one previous manic or mixed episode
  • meet 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Bipolar DisorderMania

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

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

May 2, 2002

First Posted

May 3, 2002

Study Start

July 1, 2001

Study Completion

November 1, 2002

Last Updated

June 8, 2011

Record last verified: 2011-01