Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)
Timeframe: Eight weeks
Secondary outcomes:
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)
Timeframe: Eight weeks
Interventions:
Drug: Placebo
Drug: lamotrigine
Enrollment:
221
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Bipolar Disorder
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
November 2003 to August 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion
- Patients must provide written and informed consent.
Inclusion and exclusion criteria
Inclusion 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.
Trial location(s)
Location
GSK Investigational Site
Princeton, New Jersey, United States, 08540
Status
Study Complete
Location
GSK Investigational Site
Terre Haute, Indiana, United States, 47802
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92108
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71101
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30060
Status
Study Complete
Location
GSK Investigational Site
Loma Linda, California, United States, 92354
Status
Study Complete
Location
GSK Investigational Site
Burbank, California, United States, 91506
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73118
Status
Study Complete
Location
GSK Investigational Site
Galveston, Texas, United States, 77555-0188
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Clementon, New Jersey, United States, 08021
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
Status
Study Complete
Location
GSK Investigational Site
Pleasantville, New York, United States, 10570
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-26-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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