Major Depressive Disorder Study In Adults
Phase 4
Completed
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT00049972
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
A study to obtain safety and tolerability data
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 646
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events
- Secondary Outcome Measures
Name Time Method Recurrence rates of adverse events causing intolerability of previous SSRI/SNRI, Adverse event incidence rates, Mean change from baseline in the Beck Depression Inventory-II total score, Proportion of responsers based on teh CGI Global Improvement Item
Trial Locations
- Locations (1)
GSK Clinical Trial Call Center
🇺🇸Kirkland, Washington, United States