Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ

NCT ID: NCT02548949

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-25
• Study Completion Date: 2020-02-12

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

Conditions

Major Depressive Disorder

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Chungbuk National University Hospital

Cheongju-si, Chungcheonbuk-do, South Korea

Hallym University Dongtan Sacred Heart Hospital/Department of Neuropsychiatry

Hwaseong-si, Gyeonggi Province, South Korea

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Roa Neurology Clinic/Neurology

Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

Bundang Cha Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Konkuk University Chungju Hospital / Department of Psychiatry

Chungju, North Chungcheong, South Korea

Bong Seng Memorial Hospital

Busan, , South Korea

Pusan National University Hospital

Busan, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Chuncheon Sacred Heart Hospital-Hallym University

Gangwon-do, , South Korea

Chosun University Hospital

Gwangju, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Presbyterian Medical Center

Jeonju, , South Korea

Nowon Eulji Medical Center, Eulji University

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Hanyang University Seoul Hospital

Seoul, , South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Kyung Hee University Hospital at Gangdong Department of Psychiatry

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 35879039 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B2061143

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

Other Identifiers

B2061143

Identifier Type: -

Identifier Source: org_study_id