Last updated: 11/04/2018 10:02:43
An 8 Week Study Of Depression In Adults Diagnosed with Major Depressive Disorder
GSK study ID
OHB20002
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose Study Evaluating Efficacy, Safety, and Tolerability of Once-Daily Oral GW353162 (20-40-60mg) Versus Placebo in Subjects with Major Depressive Disorder Over an Eight-Week Treatment Period.
Trial description: A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at the end of the treatment period (Week 8) for the Last Observation Carried Forward (LOCF)
Timeframe: Randomization visit (Week 0) and Week 8
Secondary outcomes:
Change from randomization in the MADRS total score at Weeks 1, 2, 3, 4, and 6 for the LOCF
Timeframe: Randomization visit (Week 0) and Week 1, 2, 3, 4 and Week 6.
Change from randomization in the MADRS Item 2 score (Reported Sadness) at Weeks 1, 2, 3, 4, 6, and 8, for LOCF
Timeframe: Randomization visit (Week 0) and Week 1, 2, 3, 4, 6 and Week 8.
Percentage of MADRS responders at Weeks 1, 2, 3, 4, 6, and 8
Timeframe: At Weeks 1, 2, 3, 4, 6, and 8
Percentage of remitters at Weeks 1, 2, 3, 4, 6, and 8.
Timeframe: At Weeks 1, 2, 3, 4, 6, and 8
The Estimated Probability of Maintained Response to the End of the Treatment Phase at Week 8
Timeframe: At Week 8
Percentage of participants considered responders using the Clinical Global Impression Improvement of Illness (CGI-I) scale at weeks 1, 2, 3, 4, 6, and 8, for LOCF
Timeframe: At weeks 1, 2, 3, 4, 6, and 8
Change from randomization in the Clinical Global Impression Severity of Illness (CGI-S) score at Weeks 1, 2, 3, 4, 6, and 8
Timeframe: Randomization (Week 0) and Weeks 1, 2, 3, 4, 6, and 8
Change from randomization in the Hospital Anxiety and Depression (HAD) Scale anxiety subscale (HADS-A) depression subscale, (HADS-D) and total score at Weeks 2, 4, and 8
Timeframe: Randomization (Week 0) and Weeks 2, 4, and 8
Change from randomization in the Sheehan Disability Scale (SDS) total score at Week 8
Timeframe: Randomization visit (Week 0) and Week 8
Change from randomization at Week 8 in total score on the Motivation and Energy Inventory (MEI) scale
Timeframe: Randomization visit (Week 0) and Week 8 (prem disc)
Change from randomization in the Pain Assessment Scale at Week 8
Timeframe: Randomization visit (Week 0) and Week 8
Change from randomization in the Fatigue Severity Scale (FSS) total score at Week 8
Timeframe: Randomization visit (Week 0) and Week 8
Number of participants with specific Subject Satisfaction with Study Medication Question score at Week 8
Timeframe: Week 8 or study discontinuation
Interventions:
Drug: GW353162
Drug: Placebo
Enrollment:
367
Observational study model:
Not applicable
Primary completion date:
2007-07-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder, Major
Product
radafaxine
Collaborators
Not applicable
Study date(s)
March 2003 to April 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
No
- Diagnosis of Major Depressive Disorder (MDD)
- Duration of current depressive episode 12 weeks - 24 months
- Patients have other psychiatric disorders that would affect patient's response to treatment
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of Major Depressive Disorder (MDD)
- Duration of current depressive episode 12 weeks
- 24 months
- Patients can read and write at a level sufficient to provide a signed consent
- If female, patients must be practicing an acceptable method of birth control
Exclusion criteria:
- Patients have other psychiatric disorders that would affect patient's response to treatment
- Patients have not responded to two or more adequate courses of antidepressant therapy
- Patients cannot be currently abusing illicit drugs or alcohol
- Patients are not currently receiving psychotherapy
- Patients have received electroconvulsive therapy within 6 months prior to screening
- Patients are pregnant or lactating
Trial location(s)
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106
Status
Study Complete
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Study Complete
Location
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828
Status
Study Complete
Location
GSK Investigational Site
Terre Haute, Indiana, United States, 47802
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27514
Status
Study Complete
Location
GSK Investigational Site
Brockton, Massachusetts, United States, 2301
Status
Study Complete
Location
GSK Investigational Site
National City, California, United States, 91950
Status
Study Complete
Location
GSK Investigational Site
Garden Grove, California, United States, 92845
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Irvine, California, United States, 92618
Status
Study Complete
Location
GSK Investigational Site
Lake Jackson, Texas, United States, 77566
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Study Complete
Location
GSK Investigational Site
Galveston, Texas, United States, 77555
Status
Study Complete
Location
GSK Investigational Site
Florence, Kentucky, United States, 41042
Status
Study Complete
Location
GSK Investigational Site
Springfield, Illinois, United States, 62702
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-07-04
Actual study completion date
2007-07-04
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
Additional information
Not applicable
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