Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Double blind placebo controlled study of lamictal in acute bipolar depression
Trial description: A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder
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: 8 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: 8 Weeks
Interventions:
Drug: lamotrigine
Enrollment:
150
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)
February 2003 to December 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Patients must provide written and informed consent
- Diagnosis of Bipolar I Disorder and currently depressed for minimum of the previous 8 weeks
- Patients must not be suicidal
- Patients must not have a history or non-response to antidepressant treatment
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Trial location(s)
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45242
Status
Study Complete
Location
GSK Investigational Site
Brown Deer, Wisconsin, United States, 53223
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90210
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30060
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Terre Haute, Indiana, United States, 47802
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71101
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92108
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Pleasantville, New York, United States, 10570
Status
Study Complete
Location
GSK Investigational Site
La Jolla, California, United States, 92093
Status
Study Complete
Location
GSK Investigational Site
Brecksville, Ohio, United States, 44141
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 77090
Status
Study Complete
Location
GSK Investigational Site
Princeton, New Jersey, United States, 08540
Status
Study Complete
Location
GSK Investigational Site
Santa Ana, California, United States, 92705
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
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
2005-14-12
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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