N/A
N=700
Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02548949 ↗Enrolled (actual)
700
Serious AEs
0.4%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 80; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
80; 3 | — |
| PRIMARY Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale |
22; 128; 237; 65; 2; 0 | — |
| PRIMARY Number of Participants With Final Effectiveness Evaluation |
411; 68; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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'
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT02548949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.