Bipolar Disorder Study for Men and Women
Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression
1 other identifier
interventional
150
1 country
20
Brief Summary
A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2003
Typical duration for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2003
CompletedFirst Submitted
Initial submission to the registry
March 10, 2003
CompletedFirst Posted
Study publicly available on registry
March 11, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2005
CompletedApril 7, 2017
April 1, 2017
2.4 years
March 10, 2003
April 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)
8 Weeks
Secondary Outcomes (1)
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).
8 Weeks
Study Arms (1)
Arm 1
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (20)
GSK Investigational Site
Beverly Hills, California, 90210, United States
GSK Investigational Site
La Jolla, California, 92093, United States
GSK Investigational Site
San Diego, California, 92108, United States
GSK Investigational Site
Santa Ana, California, 92705, United States
GSK Investigational Site
Marietta, Georgia, 30060, United States
GSK Investigational Site
Terre Haute, Indiana, 47802, United States
GSK Investigational Site
Shreveport, Louisiana, 71101, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
Princeton, New Jersey, 08540, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
Pleasantville, New York, 10570, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Brecksville, Ohio, 44141, United States
GSK Investigational Site
Cincinnati, Ohio, 45242, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
San Antonio, Texas, 77090, United States
GSK Investigational Site
Brown Deer, Wisconsin, 53223, United States
Related Publications (1)
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.
PMID: 34523118DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2003
First Posted
March 11, 2003
Study Start
February 27, 2003
Primary Completion
August 1, 2005
Study Completion
December 14, 2005
Last Updated
April 7, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.