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:
NCT00099229
First received: December 10, 2004
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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


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 and Tolerability of Licarbazepine 1000-2000mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder Over 3 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 3).

Secondary Outcome Measures:
  • Major improvement in anxiety and depression from baseline to endpoint (Week 3)

Enrollment: 320
Study Start Date: November 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099229

Locations
United States, Arkansas
Investigational Site
Little Rock, Arkansas, United States, 72211
United States, California
Investigational Site
Cerritos, California, United States, 90703
Investigational Site
San Diego, California, United States, 92126
United States, Florida
Investigational Site
Port Charlotte, Florida, United States, 33952
United States, Indiana
Investigational Site
Indianapolis, Indiana, United States, 46222
United States, Kansas
Investigational Site
Newton, Kansas, United States, 67114
United States, Nevada
Investigational Site
Las Vegas, Nevada, United States, 89103
United States, North Carolina
Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
Investigational Site
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
Investigational Site
Oklahoma City, Oklahoma, United States, 73118
United States, Pennsylvania
Investigational Site
Philadelphia, Pennsylvania, United States, 19124
United States, Texas
Investigational Site
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
United States, Washington
Investigational Site
Kirkland, Washington, United States, 98033
France
Investigational Site
Dijon, France, 21033
Investigational Site
Strasbourg, France, 67091
Russian Federation
Investigational Site
Moscow, Russian Federation, 107076
Investigational Site
Moscow, Russian Federation, 113152
Investigational Site
Moscow, Russian Federation, 123367
Investigational Site
St. Petersburg, Russian Federation, 193019
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: NCT00099229     History of Changes
Other Study ID Numbers: CLIC477D2301
Study First Received: December 10, 2004
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
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014