Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungbuk National University Hospital, Cheongju-si, Chungcheonbuk-do, South Korea

About this study

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)".

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults 19 years of age or older, who have been received at least one dose of PRISTIQ® for the treatment of Major depressive disorder (MDD).
Patients who have been received for the first time after signed the 'data privacy statement'

Exclusion criteria

Patients to whom PRISTIQ® is contraindicated as per the local labeling;

Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ® formulation.
Serotonin syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with PRISTIQ® or Do not use PRISTIQ® within 14 days of stopping an MAOI intended to treat psychiatric disorders

Treatment and study plan

Primary outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Up to 8 weeks

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale

Time frame: At Week 8

CGI-I scale was a 7-point scale used to assess clinical effectiveness on a range of 1 to 7; where, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = No change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition/lower clinical effectiveness.
Number of Participants With Final Effectiveness Evaluation

Time frame: At Week 8

Final effectiveness was evaluated as 'improved', 'no change', 'worse' or 'unevaluable' based on overall participant's clinical response after 8 weeks of Pristiq administration (as part of routine care), where, Improved = there was the improvement of symptoms related to major depressive disorder, No change = there was no significant change compared to participant's status before Pristiq administration, Worse = symptoms were getting worse compared to participant's status before Pristiq administration, Unevaluable = the medical charts do not had adequate progress notes to make a judgment on clinical response.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

KOREAN POST MARKETING SURVEILLANCE TO OBSERVE EFFECTIVENESS AND SAFETY OF PRISTIQ (REGISTERED) IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER.

Acronym: PMS

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Sep 14, 2015
Registry last updated: Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed