Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ (PMS)

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

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 Overview

• Status: Completed
• Conditions: Major Depressive Disorder

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 Type: Observational
• Enrollment (Actual): 700

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Pusan National University Hospital
  • Busan, Korea, Republic of, 601-723
    • Bong Seng Memorial Hospital
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National University Hospital
  • Daejeon, Korea, Republic of, 301-721
    • Chungnam National University Hospital
  • Gangwon-do, Korea, Republic of, 24253
    • Chuncheon Sacred Heart Hospital-Hallym University
  • Gwangju, Korea, Republic of, 61469
    • Chonnam National University Hospital
  • Gwangju, Korea, Republic of, 61453
    • Chosun University Hospital
  • Jeonju, Korea, Republic of, 560-750
    • Presbyterian Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06973
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of, 01830
    • Nowon Eulji Medical Center, Eulji University
  • Seoul, Korea, Republic of, 04763
    • Hanyang University Seoul Hospital
  • Seoul, Korea, Republic of
    • Kyung Hee University Hospital at Gangdong Department of Psychiatry
  • Chungcheonbuk-do
    • Cheongju-si, Chungcheonbuk-do, Korea, Republic of, 362-711
      • Chungbuk National University Hospital
  • Chungcheongbuk-do
    • Chungju-si, Chungcheongbuk-do, Korea, Republic of, 27376
      • Konkuk University Chungju Hospital / Department of Psychiatry
  • Gyeonggi Province
    • Hwaseong-si, Gyeonggi Province, Korea, Republic of, 18450
      • Hallym University Dongtan Sacred Heart Hospital/Department of Neuropsychiatry
  • Gyeonggi-do
    • Anyang-Si, Gyeonggi-do, Korea, Republic of, 431-796
      • Hallym University Sacred Heart Hospital
    • Bundang-gu, Seongnam-si, Gyeonggi-do, Korea, Republic of, 13618
      • Roa Neurology Clinic/Neurology
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 411-706
      • Inje University Ilsan Paik Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
      • Bundang Cha Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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). The study population would be enrolled in multi-center in which subjects are administered PRISTIQ as part of routine practice at Korean health care centers by accredited psychiatrists.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	Up to 8 weeks
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale	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.	At Week 8
Number of Participants With Final Effectiveness Evaluation	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.	At Week 8

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Roh S, Lee KS, Choi S, Kim JM. Safety and Effectiveness of Desvenlafaxine in Korean Patients with Major Depressive Disorder: A 6-month Postmarketing Surveillance Study. Clin Psychopharmacol Neurosci. 2022 Aug 31;20(3):548-559. doi: 10.9758/cpn.2022.20.3.548.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2016
• Primary Completion (Actual): February 12, 2020
• Study Completion (Actual): February 12, 2020

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: B2061143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.