Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT02548949
• Lead Sponsor: Pfizer

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-14
• Study Start: 2016-04-25
• Primary Completion: 2020-02-12
• Study Completion: 2020-02-12
• Status Verified: 2021-01
• Results First Submitted: 2021-01-21
• Results First Submitted QC: 2021-01-21
• Last Update Submitted: 2021-01-21
• Results First Posted: 2021-02-09
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1. 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).
2. 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;

1. Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ® formulation.
2. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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	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	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.

Trial Locations

Locations (22)

Chungbuk National University Hospital; 🇰🇷 Cheongju-si, Chungcheonbuk-do, Korea, Republic of

Konkuk University Chungju Hospital / Department of Psychiatry; 🇰🇷 Chungju-si, Chungcheongbuk-do, Korea, Republic of

Hallym University Dongtan Sacred Heart Hospital/Department of Neuropsychiatry; 🇰🇷 Hwaseong-si, Gyeonggi Province, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang-Si, Gyeonggi-do, Korea, Republic of

Roa Neurology Clinic/Neurology; 🇰🇷 Bundang-gu, Seongnam-si, Gyeonggi-do, Korea, Republic of

Bundang Cha Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Bong Seng Memorial Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Chosun University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Presbyterian Medical Center; 🇰🇷 Jeonju, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Nowon Eulji Medical Center, Eulji University; 🇰🇷 Seoul, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Chuncheon Sacred Heart Hospital-Hallym University; 🇰🇷 Gangwon-do, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Hanyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Hospital at Gangdong Department of Psychiatry; 🇰🇷 Seoul, Korea, Republic of

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of