Switching to Duloxetine From Other Antidepressants
Phase 4
Completed
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT00191932
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
A multicentre, randomised, open label study of out-patients with major depression who have failed to respond adequately to antidepressant treatment for their current episode of depression. The study compares outcomes associated with two methods of switching from current antidepressant to duloxetine
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
- Male and female outpatients of at least 18 years of age, who meet criteria for Major Depressive Disorder (MDD)
- Currently non- or only partially-responsive to an SSRI antidepressant after at least 5 weeks of treatment
Exclusion Criteria include:
- Current primary Axis I disorder other than MDD
- Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
- Patients judged to be at serious suicidal risk.
- Serious medical illness
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch
- Secondary Outcome Measures
Name Time Method To compare the efficacy, health outcomes, safety and tolerability associated with the above two switching methods, as measured by HAMD17, CGI-S, PGI-I, SF-36, spontaneously reported adverse events , vital signs and other measures.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
🇬🇧Wythenshawe, United Kingdom