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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00107939
First received: April 11, 2005
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Licarbazepine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6)

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

Enrollment: 453
Study Start Date: November 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107939

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

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00107939     History of Changes
Other Study ID Numbers: CLIC477D2302
Study First Received: April 11, 2005
Last Updated: November 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
bipolar disorder
manic episode
treatment
licarbazepine

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014