A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.
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|ClinicalTrials.gov Identifier: NCT01288079|
Recruitment Status : Terminated
First Posted : February 2, 2011
Results First Posted : October 29, 2012
Last Update Posted : November 20, 2012
Information provided by (Responsible Party):
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
Major Depressive Disorder
|Recruitment Details||This multicenter study was conducted in Europe, Asia, and North America between 4 February 2011 and 26 April 2012.|
|Pre-assignment Details||21-day screening/washout and 8-week prospective open-label SSRI(selective serotonin reuptake inhibitors)/SNRI(selective serotonin and norepinephrine reuptake inhibitors) periods to identify population of inadequate responders(<50% reduction in Hamilton Rating Scale for Depression total score of ≥16 and a Clinical Global Impression-Severity ≥4).|
The study was terminated early and thus only a fraction of the planned number of patients were randomized and many did not complete the study. As a consequence the possibility of interpreting efficacy over an 8 week period is considerably reduced.