Last updated on May 2019

Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ


Brief description of study

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.

Detailed Study Description

The objective of this study is to determine any problems or questions associated with Pristiq after marketing, with regard to the following clauses under conditions of general clinical practice, in compliance with the regulation "Re-examination guideline of new drugs (Ministry of Food and Drug Safety Notification 2013-251, 2013.12.20)".

  1. Serious adverse event/adverse drug reaction
  2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.
  3. Known adverse drug reaction
  4. Non-serious adverse drug reaction
  5. Other safety and effectiveness information

Clinical Study Identifier: NCT02548949

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Korea University Anam Hospital

Seoul, Korea, Republic of
4.3miles
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Hanyang University Seoul Hospital

Seoul, Korea, Republic of
4.3miles
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Chung-Ang University Hospital

Seoul, Korea, Republic of
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Konkuk University Medical Center

Seoul, Korea, Republic of
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Seoul National University Hospital

Seoul, Korea, Republic of
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Hallym University Sacred Heart Hospital

Anyang-Si, Korea, Republic of
8.22miles
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