| Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ
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| KOREAN POST MARKETING SURVEILLANCE TO OBSERVE EFFECTIVENESS AND SAFETY OF PRISTIQ (REGISTERED) IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER.
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| 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.
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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)".
- Serious adverse event/adverse drug reaction
- Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.
- Known adverse drug reaction
- Non-serious adverse drug reaction
- Other safety and effectiveness information
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| Observational
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Observational Model: Case-Only
Time Perspective: Prospective
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| Not Provided
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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.
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| Non-Probability Sample
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| 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.
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| Major Depressive Disorder
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| Not Provided
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| Not Provided
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| Not Provided
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| Recruiting
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| 600
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Same as current
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| February 12, 2020
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| February 12, 2020 (Final data collection date for primary outcome measure)
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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
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| Sexes Eligible for Study: |
All |
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| 19 Years and older (Adult, Older Adult)
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| No
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| Korea, Republic of
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| NCT02548949
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| B2061143
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| No
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| Not Provided
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| Plan to Share IPD: |
No |
| Plan Description: |
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da.... |
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| Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| January 2020
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