Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
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
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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
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 Affective Disorders, Psychotic Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013