Major Depressive Disorder Clinical Trial
— PMSOfficial title:
KOREAN POST MARKETING SURVEILLANCE TO OBSERVE EFFECTIVENESS AND SAFETY OF PRISTIQ (REGISTERED) IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER.
NCT number | NCT02548949 |
Other study ID # | B2061143 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 25, 2016 |
Est. completion date | February 12, 2020 |
Verified date | January 2021 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 700 |
Est. completion date | February 12, 2020 |
Est. primary completion date | February 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
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 | Bong Seng Memorial Hospital | Busan | |
Korea, Republic of | Pusan National University Hospital | Busan | |
Korea, Republic of | 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 | Kyungpook National University Hospital | Daegu | |
Korea, Republic of | Chungnam National University Hospital | Daejeon | |
Korea, Republic of | Chuncheon Sacred Heart Hospital-Hallym University | Gangwon-do | |
Korea, Republic of | Inje University Ilsan Paik Hospital | Goyang-si | Gyeonggi-do |
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Chosun University Hospital | Gwangju | |
Korea, Republic of | Hallym University Dongtan Sacred Heart Hospital/Department of Neuropsychiatry | Hwaseong-si | Gyeonggi Province |
Korea, Republic of | Presbyterian Medical Center | Jeonju | |
Korea, Republic of | Bundang Cha Medical Center | Seongnam-si | Gyeonggi-do |
Korea, Republic of | Chung-Ang University Hospital | Seoul | |
Korea, Republic of | Hanyang University Seoul Hospital | Seoul | |
Korea, Republic of | Konkuk University Medical Center | Seoul | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | Kyung Hee University Hospital at Gangdong Department of Psychiatry | Seoul | |
Korea, Republic of | Nowon Eulji Medical Center, Eulji University | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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