Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ

NCT02548949 | Completed Results

• 1 other identifier: B2061143
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 22

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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'

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (22)

Chungbuk National University Hospital

Cheongju-si, Chungcheonbuk-do, 362-711, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital/Department of Neuropsychiatry

Hwaseong-si, Gyeonggi Province, 18450, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 431-796, South Korea

Location

Roa Neurology Clinic/Neurology

Bundang-gu, Seongnam-si, Gyeonggi-do, 13618, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 411-706, South Korea

Location

Bundang Cha Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Konkuk University Chungju Hospital / Department of Psychiatry

Chungju, North Chungcheong, 27376, South Korea

Location

Bong Seng Memorial Hospital

Busan, 601-723, South Korea

Location

Pusan National University Hospital

Busan, 602-739, South Korea

Location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Chungnam National University Hospital

Daejeon, 301-721, South Korea

Location

Chuncheon Sacred Heart Hospital-Hallym University

Gangwon-do, 24253, South Korea

Location

Chosun University Hospital

Gwangju, 61453, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Presbyterian Medical Center

Jeonju, 560-750, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 01830, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

Kyung Hee University Hospital at Gangdong Department of Psychiatry

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 35879039 DERIVED

Related Links

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

Biospecimen

Retention: NONE RETAINED

Retention of biospecimen is not needed necessarily. If the investigator check blood sample under routine practice during the study, investigator record results of blood sampling, such as CBC and blood chemistry. Full lists of recordings are following : Hemoglobin, Hematocrit, RBC, WBC, Platelets, Sodium, Potassium, BUN, Creatinine, Calcium, Total Bilirubin, SGOT/AST, SGPT/ALT, Cholesterol.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: September 14, 2015
• Study Start: April 25, 2016
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: February 9, 2021
• Results First Posted: February 9, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (22)