Last updated: 11/04/2018 10:02:50
An 8 Week Study Of Adults Diagnosed with Major Depressive Disorder
GSK study ID
OHB20003
Clinicaltrials.gov ID
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 (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) score after 8 weeks of treatment
Timeframe: 8 Weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: Radafaxine
Enrollment:
365
Observational study model:
Not applicable
Primary completion date:
Not applicable
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 2004
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
- Patients have not responded to two or more adequate courses of antidepressant therapy
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
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71101
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38119
Status
Study Complete
Location
GSK Investigational Site
Cerritos, California, United States, 90703
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229-3815
Status
Study Complete
Location
GSK Investigational Site
Libertyville, Illinois, United States, 60048
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Rockville, Maryland, United States, 20852
Status
Study Complete
Location
GSK Investigational Site
Lafayette, Indiana, United States, 47905
Status
Study Complete
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20037
Status
Study Complete
Location
GSK Investigational Site
Oakbrook Terrace, Illinois, United States, 60181
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Washington, United States, 98004
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92108
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-16-04
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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