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

March 20, 2017 updated by: Novartis Pharmaceuticals
The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional treatment with either lithium or valproate, which are already FDA (Food and Drug Administration)-approved treatments for mania.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

343

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

  • Austria
      • Vienna, Austria
        • Novartis Investigational Site
  • Canada
      • Kelowna, Canada
        • Novartis Investigational Site
      • London, Canada
        • Novartis Investigator Site
      • Montreal, Canada
        • Novartis Investigator Site
      • Sudbury, Canada
        • Novartis Investigator Site
      • Vancouver, Canada
        • Novartis Investigator Site
      • Verdun, Canada
        • Novartis Investigator Site
  • Colombia
      • Bogota, Colombia
        • Guatemala
      • Medellin, Colombia
        • Guatemala
      • Pareira, Colombia
        • Guatemala
  • Czech Republic
      • Brno, Czech Republic
        • Novartis Investigational Site
      • Hradec Kralove, Czech Republic
        • Novartis Investigational Site
      • Prague, Czech Republic
        • Novartis Investigational Site
  • Germany
      • Berlin, Germany
        • Novartis Investigational Site
      • Bochum, Germany
        • Novartis Investigational Site
      • Dresden, Germany
        • Novartis Investigational Site
      • Ingolstadt, Germany
        • Novartis Investigational Site
      • Mannheim, Germany
        • Novartis Investigational Site
      • Wurzburg, Germany
        • Novartis Investigational Site
  • Guatemala
      • Guatemala city, Guatemala
        • Novartis Investigational Site
  • Peru
      • Lima, Peru
        • Novartis Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • Novartis Investigational Site
      • Yaroslavl, Russian Federation
        • Novartis Investigational Site
  • Slovakia
      • Bojnice, Slovakia
        • Novartis Investigational Site
      • Michalovce, Slovakia
        • Novartis Investigational Site
  • South Africa
      • Durban, South Africa
        • Novartis Investigational Site
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • Novartis Investigational Site
      • Kiev, Ukraine
        • Novartis Investigational Site
      • Lugansk, Ukraine
        • Novartis Investigational Site
      • Odessa, Ukraine
        • Novartis Investigational Site
      • Simferopol, Ukraine
        • Novartis Investigational Site
  • United States
    • California
      • La Palma, California, United States, 90623
        • Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Investigational Site
    • Massachusetts
      • Somerville, Massachusetts, United States, 02143
        • Investigational Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Investigational Site
    • New York
      • Staten Island, New York, United States, 10305
        • Investigational Site
    • Tennessee
      • Madison, Tennessee, United States, 37115
        • Investigational Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • Investigational Site
      • Dallas, Texas, United States, 75235
        • Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Investigational Site
      • Kirkland, Washington, United States, 98033
        • Investigational Site
    • Wisconsin
      • West Allis, Wisconsin, United States, 53227
        • Investigational Site
  • Venezuela
      • Caracas, Venezuela
        • Novartis 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: licarbazepine
Drug: Licarbazepine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6).

Secondary Outcome Measures

Outcome Measure
Major improvement in anxiety and depression from baseline to endpoint (week 6)

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

October 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

April 11, 2005

First Submitted That Met QC Criteria

April 11, 2005

First Posted (Estimate)

April 12, 2005

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIC477D2303

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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