Bipolar Disorder Study for Men and Women
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00056277
First received: March 10, 2003
Last updated: March 25, 2011
Last verified: March 2011
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Purpose
A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: lamotrigine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Bipolar Disorder Patients Currently Experiencing a Major Depressive Episode |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 Weeks ]
Secondary Outcome Measures:
- Change from baseline scores at Week 8 for the Hamilton Depression Rating Scale (HAMD-17, HAMD-31, Bech Melancholia Scale (BMS), and HAMD - Item 1), Clinical Global Impressions of Severity (CGI-S) and Improvement (CGI-I). [ Time Frame: 8 Weeks ]
| Enrollment: | 260 |
| Study Start Date: | February 2003 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: lamotrigine
Other Name: lamotrigine
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must provide written and informed consent
- Diagnosis of Bipolar I Disorder and currently depressed for minimum of the previous 8 weeks
- Patients must have been hospitalized for mood disorder or incarceration with or without formal charges as the result of mania related behavior
Exclusion Criteria:
- Patients must not be suicidal
- Patients must not have a history or non-response to antidepressant treatment
- Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry
- Patients must not have had epilepsy or hypothyroidism
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056277
Locations
| United States, California | |
| GSK Investigational Site | |
| Beverly Hills, California, United States, 90210 | |
| GSK Investigational Site | |
| La Jolla, California, United States, 92093 | |
| GSK Investigational Site | |
| San Diego, California, United States, 92108 | |
| GSK Investigational Site | |
| Santa Ana, California, United States, 92705 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Marietta, Georgia, United States, 30060 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, Missouri | |
| GSK Investigational Site | |
| St. Charles, Missouri, United States, 63301 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Princeton, New Jersey, United States, 08540 | |
| United States, New York | |
| GSK Investigational Site | |
| New York, New York, United States, 10021 | |
| GSK Investigational Site | |
| Pleasantville, New York, United States, 10570 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Brecksville, Ohio, United States, 44141 | |
| GSK Investigational Site | |
| Cincinnati, Ohio, United States, 45242 | |
| GSK Investigational Site | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Eugene, Oregon, United States, 97401 | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97210 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Texas | |
| GSK Investigational Site | |
| San Antonio, Texas, United States | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Brown Deer, Wisconsin, United States, 53223 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00056277 History of Changes |
| Other Study ID Numbers: | SCA30924 |
| Study First Received: | March 10, 2003 |
| Last Updated: | March 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Lamotrigine Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Anticonvulsants Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013