At a glance
ClinicalIndex Comparison RecordN/ACompleted· 700 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
KOREAN POST MARKETING SURVEILLANCE TO OBSERVE EFFECTIVENESS AND SAFETY OF PRISTIQ (REGISTERED) IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER.
In Brief
An observational study for Major Depressive Disorder. Completed, enrolled 700 participants across 22 sites.
Detailed Summary
On 6 Feb 2014, Pristiq was approved for the treatment of Major Depressive Disorder(MDD) in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS for 600 patients by 5 Feb 2020. Post marketing surveillance is required to determine any problems or questions associated with Pristiq after marketing, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of pristiq will be observed.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesSouth Korea
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartApr 2016
Primary CompletionFeb 2020
TodayJul 2026
First PostedSep 14, 2015
Enrollment StartApr 25, 2016
Primary CompletionFeb 12, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.8 years ago