Depression And Bipolar Disorder
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00274677
First received: January 9, 2006
Last updated: October 25, 2012
Last verified: October 2012
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Purpose
This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: Placebo 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 Major Depression in Patients With Type II Bipolar Disorder |
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: Eight weeks ] [ Designated as safety issue: No ]
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: Eight weeks ] [ Designated as safety issue: No ]
| Enrollment: | 221 |
| Study Start Date: | November 2003 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: lamotrigine
Experimental treatment
Other Name: Placebo
|
| Experimental: lamotrigine |
Drug: Placebo
Experimental treatment arm
Other Name: placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion
- Patients must provide written and informed consent.
- Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks.
Exclusion
- Patients must not be suicidal.
- Patients must not have a history of 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: NCT00274677
Locations
| United States, California | |
| GSK Investigational Site | |
| Burbank, California, United States, 91506 | |
| GSK Investigational Site | |
| Loma Linda, California, United States, 92354 | |
| GSK Investigational Site | |
| San Diego, California, United States, 92108 | |
| 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 | |
| Clementon, New Jersey, United States, 08021 | |
| 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 | |
| Charlotte, North Carolina, United States, 28209 | |
| GSK Investigational Site | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Beachwood, Ohio, United States, 44122 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73118 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Eugene, Oregon, United States, 97401 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Texas | |
| GSK Investigational Site | |
| Galveston, Texas, United States, 77555-0188 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77090 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00274677 History of Changes |
| Obsolete Identifiers: | NCT00076882 |
| Other Study ID Numbers: | SCA100223 |
| Study First Received: | January 9, 2006 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Bipolar Disorder |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms 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 June 17, 2013