Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

February 21, 2017 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Tolerability of Licarbazepine 1000-2000mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder Over 3 Weeks

This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21033
        • Investigational Site
      • Strasbourg, France, 67091
        • Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 107076
        • Investigational Site
      • Moscow, Russian Federation, 113152
        • Investigational Site
      • Moscow, Russian Federation, 123367
        • Investigational Site
      • St. Petersburg, Russian Federation, 193019
        • Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Investigational Site
    • California
      • Cerritos, California, United States, 90703
        • Investigational Site
      • San Diego, California, United States, 92126
        • Investigational Site
    • Florida
      • Port Charlotte, Florida, United States, 33952
        • Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46222
        • Investigational Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89103
        • Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19124
        • Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • Investigational Site
      • Bellaire, Texas, United States, 77401
        • Investigational Site
      • Houston, Texas, United States, 77007
        • Investigational Site
      • Houston, Texas, United States, 77021
        • Investigational Site
    • Washington
      • Kirkland, Washington, United States, 98033
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling)
  • In need of psychiatric treatment
  • Cooperation and willingness to complete all aspects of the study

Exclusion Criteria:

  • Current diagnosis other than bipolar I disorder
  • History of schizophrenia or schizoaffective disorder
  • Drug dependence within 1 month prior to study start or testing positive in a urine drug test
  • Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others
  • Any form of psychotherapy within 1 month prior to study start

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (Week 3).

Secondary Outcome Measures

Outcome Measure
Major improvement in anxiety and depression from baseline to endpoint (Week 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

December 10, 2004

First Submitted That Met QC Criteria

December 9, 2004

First Posted (Estimate)

December 10, 2004

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIC477D2301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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