Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ
NCT02548949
ABOUT THIS STUDY
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Adult Trials: 18+ Years
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'
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
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ | ||||
| Official Title | KOREAN POST MARKETING SURVEILLANCE TO OBSERVE EFFECTIVENESS AND SAFETY OF PRISTIQ (REGISTERED) IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER. | ||||
| 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)".
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| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: None Retained Description: 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. | ||||
| 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. | ||||
| Condition | Major Depressive Disorder | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment | 700 | ||||
| Original Estimated Enrollment | 600 | ||||
| Actual Study Completion Date | February 12, 2020 | ||||
| Actual Primary Completion Date | February 12, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: Patients to whom PRISTIQ® is contraindicated as per the local labeling;
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| Sex/Gender |
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| Ages | 19 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT02548949 | ||||
| Other Study ID Numbers | B2061143 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
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| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | January 2021 | ||||