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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.
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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients to whom PRISTIQ® is contraindicated as per the local labeling;
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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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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheongju-si | Chungcheonbuk-do | 362-711 | South Korea | ||
| Hallym University Dongtan Sacred Heart Hospital/Department of Neuropsychiatry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35879039 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pristiq | Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2019 | Jan 20, 2021 |
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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.
| Hwaseong-si |
| Gyeonggi Province |
| 18450 |
| South Korea |
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | 431-796 | South Korea |
| Roa Neurology Clinic/Neurology | Bundang-gu, Seongnam-si | Gyeonggi-do | 13618 | South Korea |
| Inje University Ilsan Paik Hospital | Goyang-si | Gyeonggi-do | 411-706 | South Korea |
| Bundang Cha Medical Center | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| Konkuk University Chungju Hospital / Department of Psychiatry | Chungju | North Chungcheong | 27376 | South Korea |
| Bong Seng Memorial Hospital | Busan | 601-723 | South Korea |
| Pusan National University Hospital | Busan | 602-739 | South Korea |
| Kyungpook National University Hospital | Daegu | 700-721 | South Korea |
| Chungnam National University Hospital | Daejeon | 301-721 | South Korea |
| Chuncheon Sacred Heart Hospital-Hallym University | Gangwon-do | 24253 | South Korea |
| Chosun University Hospital | Gwangju | 61453 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Presbyterian Medical Center | Jeonju | 560-750 | South Korea |
| Nowon Eulji Medical Center, Eulji University | Seoul | 01830 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Hanyang University Seoul Hospital | Seoul | 04763 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| Konkuk University Medical Center | Seoul | 143-729 | South Korea |
| Kyung Hee University Hospital at Gangdong Department of Psychiatry | Seoul | South Korea |
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| NOT COMPLETED |
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Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pristiq | Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up. | Posted | Count of Participants | Participants | 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. | Effectiveness analysis set included all participants who had been administered Pristiq at least once and were evaluated upon its related effectiveness outcomes at least once. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | 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. | Effectiveness analysis set included all participants who had been administered Pristiq at least once and were evaluated upon its related effectiveness outcomes at least once. | Posted | Count of Participants | Participants | At Week 8 |
|
|
Up to 8 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pristiq | Participants who were receiving Pristiq tablets as part of routine practice at Korean health care centers were enrolled and observed in this study for up to 8 weeks since the start of Pristiq administration. | 0 | 700 | 3 | 700 | 80 | 700 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Angina pectoris aggravated | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Chest pain | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Face oedema | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Fatigue | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Fever | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Medicine ineffective | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Oedema generalised | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Arthritis rheumatoid aggravated | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Appetite decreased | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
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| Enteritis | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
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| Gastroesophageal reflux | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
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| Mouth dry | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | WHO-ART 092 | Non-systematic Assessment |
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| Vestibular disorder | Ear and labyrinth disorders | WHO-ART 092 | Non-systematic Assessment |
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| Palpitation | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | WHO-ART 092 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | WHO-ART 092 | Non-systematic Assessment |
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| Globus hystericus | Psychiatric disorders | WHO-ART 092 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | WHO-ART 092 | Non-systematic Assessment |
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| Somnolence | Psychiatric disorders | WHO-ART 092 | Non-systematic Assessment |
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| Thinking abnormal | Psychiatric disorders | WHO-ART 092 | Non-systematic Assessment |
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| Pharyngitis | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
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| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Non-systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | WHO-ART 092 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
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| Diaphoresis | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | WHO-ART 092 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 29, 2016 | Jan 21, 2021 | Prot_001.pdf |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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