NCT00237289

Brief Summary

The purpose of this study is to assess the efficacy and safety of adding topiramate as compared to placebo to the medications a patient with bipolar disorder is already taking (lithium or valproate) to see if adding topiramate will better control the patient's manic symptoms.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
287

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2001

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

October 1, 2001

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

First QC Date

October 7, 2005

Last Update Submit

May 17, 2011

Conditions

Bipolar Disorder

Keywords

Manic depressionManiaDepressionBipolar disorderPsychosis

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline to final visit in the Young Mania Rating Scale total score. Safety evaluations (incidence of adverse events, physical exams, vital signs, clinical laboratory tests including thyroid function tests) throughout the study.

Secondary Outcomes (1)

  • Changes from baseline to final visit in the Clinical Global Impressions Scale, Global Assessment Scale, Brief Psychiatric Rating Scale, and Montgomery-Asberg Depression Rating Scale. Rate of discontinuation due to efficacy failure.

Interventions

topiramateDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of Bipolar Disorder Type I
  • Total Young Mania Rating Scale (YMRS) score of 18 or higher
  • Currently being treated with a mood stabilizer (lithium or valproate)
  • Having a stable therapeutic dose of the mood stabilizer in their bloodstream
  • Currently not requiring hospitalization

You may not qualify if:

  • Patients taking an antidepressant or anti-seizure medication
  • Hospitalized paitents
  • Women who are pregnant or breast-feeding
  • Women who are not using birth control
  • Patients with history of drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Bipolar DisorderManiaDepressionPsychotic Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Ortho McNeil Neurologics, Inc. Clinical Trial

    Ortho-McNeil Neurologics, Inc.

    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 7, 2005

First Posted

October 12, 2005

Study Start

October 1, 2001

Study Completion

October 1, 2003

Last Updated

May 19, 2011

Record last verified: 2010-04