Last updated: 11/04/2018 11:31:08
Major Depressive Disorder Study In Adults
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open label study assessing Paxil CR (paroxetine CR) in patients with major depressive disorder who discontinued treatment with selective serotonin reuptake inhibitors or a selective serotonin/norepinephrine reuptake inhibitor due to intolerability
Trial description: A study to obtain safety and tolerability data
Primary purpose:
Treatment
Trial design:
None
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
646
Primary completion date:
2003-30-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Major Depressive Disorder
Product
paroxetine
Collaborators
Not applicable
Study date(s)
September 2002 to September 2003
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Patient must have primary diagnosis of Major Depressive Disorder (MDD).
- Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability.
- Patient has previously been treated with the study drug.
- Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit.
Inclusion and exclusion criteria
Inclusion criteria:
- Patient must have primary diagnosis of Major Depressive Disorder (MDD).
- Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability.
- Minimum time frame between last dose of previous antidepressant and initiation of study drug is one week.
- Maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months.
Exclusion criteria:
- Patient has previously been treated with the study drug.
- Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit.
- Has a history of seizure disorder.
- Has met criteria for substance abuse or dependence within 6 months prior to Baseline Visit.
- Currently using an antidepressant.
- Currently pregnant.
Trial location(s)
Location
GSK Clinical Trial Call Center
LITTLE ROCK, AR, United States, 72111
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
OCALA, FL, United States, 34474
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
BIRMINGHAM, AL, United States, 83704
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
CONROE, TX, United States, 77384
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
SUGAR LAND, TX, United States, 77478
Status
Recruitment Complete
Location
GSK Clinical Trial Call Center
CINCINNATI, OH, United States, 45219
Status
Recruitment Complete
Showing 1 - 6 of 71 Results
Study documents
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
Study complete
Actual primary completion date
2003-30-09
Actual study completion date
2003-30-09
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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