Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
221 participants
INTERVENTIONAL
2003-11-30
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
lamotrigine
Experimental treatment
lamotrigine
Placebo
Experimental treatment arm
Interventions
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Placebo
Experimental treatment arm
lamotrigine
Experimental treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Burbank, California, United States
GSK Investigational Site
Loma Linda, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Marietta, Georgia, United States
GSK Investigational Site
Terre Haute, Indiana, United States
GSK Investigational Site
Shreveport, Louisiana, United States
GSK Investigational Site
Saint Charles, Missouri, United States
GSK Investigational Site
Clementon, New Jersey, United States
GSK Investigational Site
Princeton, New Jersey, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Pleasantville, New York, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Raleigh, North Carolina, United States
GSK Investigational Site
Beachwood, Ohio, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Eugene, Oregon, United States
GSK Investigational Site
Columbia, South Carolina, United States
GSK Investigational Site
Galveston, Texas, United States
GSK Investigational Site
Houston, Texas, United States
Countries
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References
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Hashimoto Y, Kotake K, Watanabe N, Fujiwara T, Sakamoto S. Lamotrigine in the maintenance treatment of bipolar disorder. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD013575. doi: 10.1002/14651858.CD013575.pub2.
Study Documents
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Document Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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SCA100223
Identifier Type: -
Identifier Source: org_study_id
NCT00076882
Identifier Type: -
Identifier Source: nct_alias
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