Last updated: 11/04/2018 10:02:36
An 8 Week Depression Study In Adults Diagnosed with Major Depressive Disorder
GSK study ID
OHB20001
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy, Safety and Tolerability of Two Doses (20mg and 60mg) of a Once-Daily Oral Formulation of GW353162 in Subjects with Major Depressive Disorder for a Treatment period of Eight Weeks
Trial description: A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Radafaxine 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:
Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy and pain;incidence of adverse events over course of study.
Timeframe: 8 Weeks
Interventions:
Drug: Radafaxine
Enrollment:
546
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Major Depressive Disorder (MDD)
Product
radafaxine
Collaborators
Not applicable
Study date(s)
March 2003 to May 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
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
Little Rock, Arkansas, United States, 72223
Status
Study Complete
Location
GSK Investigational Site
Conshohocken, Pennsylvania, United States, 19428
Status
Study Complete
Location
GSK Investigational Site
Farmington Hills, Michigan, United States, 48336
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28203
Status
Study Complete
Location
GSK Investigational Site
Edwardsville, Illinois, United States, 62025
Status
Study Complete
Location
GSK Investigational Site
Maitland, Florida, United States, 32751
Status
Study Complete
Location
GSK Investigational Site
Woodstock, Vermont, United States, 05091
Status
Study Complete
Location
GSK Investigational Site
Clementon, New Jersey, United States, 08021
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73118
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98499
Status
Study Complete
Location
GSK Investigational Site
Glen Burnie, Maryland, United States, 21061
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98104
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97209
Status
Study Complete
Location
GSK Investigational Site
Brown Deer, Wisconsin, United States, 53223
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Kenilworth, New Jersey, United States, 07033
Status
Study Complete
Location
GSK Investigational Site
Lawrence, New York, United States, 11559
Status
Study Complete
Location
GSK Investigational Site
Farmington, Connecticut, United States, 6708
Status
Study Complete
Location
GSK Investigational Site
North Miami, Florida, United States, 33161
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92660-2814
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55454
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
2004-27-05
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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