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:
NCT00107939
First received: April 11, 2005
Last updated: November 22, 2011
Last verified: November 2011
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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 May 23, 2013