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

March 20, 2017 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Licarbazepine 750 ¿ 2000 mg/d as Adjunctive Therapy to an Atypical Antipsychotic in the Treatment of Manic Episodes of Bipolar I Disorder Over 6 Weeks

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 therapy to one of the five following medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These medications are already FDA (Food and Drug Administration)-approved treatments for mania.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

453

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

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • Investigational Site
    • California
      • Orange, California, United States, 92868
        • Investigational Site
      • Pico Rivera, California, United States, 90660
        • Investigational Site
      • San Diego, California, United States, 92108
        • Investigational Site
      • San Diego, California, United States, 92126
        • Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Investigational Site
      • Joliet, Illinois, United States, 60435
        • Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46222
        • Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64133
        • Investigational Site
      • St. Louis, Missouri, United States, 63104
        • Investigational Site
    • New York
      • Brooklyne, New York, United States, 11201
        • Invetigational Site
      • Cedarhurst, New York, United States, 11516
        • Investigational Site
      • New York, New York, United States, 10003
        • Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Investigational Site
      • Columbus, Ohio, United States, 43210
        • Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Investigational Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Investigational Site
    • Wisconsin
      • West Allis, Wisconsin, United States, 53227
        • 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 6)

Secondary Outcome Measures

Outcome Measure
Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs.

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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)

April 1, 2007

Study Completion (Actual)

April 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

  • CLIC477D2302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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