Depression And Bipolar Disorder
A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Depression in Patients With Type II Bipolar Disorder
1 other identifier
interventional
221
1 country
19
Brief Summary
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.
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 Nov 2003
19 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
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 9, 2006
CompletedFirst Posted
Study publicly available on registry
January 11, 2006
CompletedSeptember 15, 2016
September 1, 2016
1.8 years
January 9, 2006
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)
Eight 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)
Eight weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORlamotrigine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients must provide written and informed consent.
- Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (19)
GSK Investigational Site
Burbank, California, 91506, United States
GSK Investigational Site
Loma Linda, California, 92354, United States
GSK Investigational Site
San Diego, California, 92108, 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
Clementon, New Jersey, 08021, 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
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Beachwood, Ohio, 44122, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73118, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Galveston, Texas, 77555-0188, United States
GSK Investigational Site
Houston, Texas, 77090, 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
January 9, 2006
First Posted
January 11, 2006
Study Start
November 1, 2003
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
September 15, 2016
Record last verified: 2016-09
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.