Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00099229 |
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Recruitment Status :
Completed
First Posted : December 10, 2004
Last Update Posted : February 23, 2017
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
- Study Details
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Brief Summary:
This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bipolar Disorder | Drug: Licarbazepine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 320 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| 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 |
| Study Start Date : | November 2004 |
| Actual Primary Completion Date : | August 2006 |
| Actual Study Completion Date : | August 2006 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Bipolar disorder
MedlinePlus related topics:
Bipolar Disorder
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)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00099229 |
| Other Study ID Numbers: |
CLIC477D2301 |
| First Posted: | December 10, 2004 Key Record Dates |
| Last Update Posted: | February 23, 2017 |
| Last Verified: | February 2017 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
|
bipolar disorder manic episode treatment licarbazepine |
Additional relevant MeSH terms:
|
Mania Disease Bipolar Disorder Pathologic Processes Bipolar and Related Disorders |
Mental Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |