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Trial record 53 of 89 for:    DESVENLAFAXINE

Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ (PMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02548949
Recruitment Status : Recruiting
First Posted : September 14, 2015
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease
Major Depressive Disorder

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)".

  1. Serious adverse event/adverse drug reaction
  2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.
  3. Known adverse drug reaction
  4. Non-serious adverse drug reaction
  5. Other safety and effectiveness information

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: KOREAN POST MARKETING SURVEILLANCE TO OBSERVE EFFECTIVENESS AND SAFETY OF PRISTIQ (REGISTERED) IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER.
Actual Study Start Date : April 25, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of adverse events categorized according to physical organ and disease/symptom [ Time Frame: 8 week ]
  2. Questionnaire of overall effectiveness of treatment [ Time Frame: 8 week ]
    rated as either improved, no change, worse, or unevaluable


Secondary Outcome Measures :
  1. Incidence of adverse events categorized according to physical organ and disease/symptom [ Time Frame: 6 month ]
    60 subjects among 600 subjects will be enrolled in long-term use study

  2. Questionnaire of overall effectiveness of treatment [ Time Frame: 6 month ]

    rated as either improved, no change, worse, or unevaluable

    60 subjects among 600 subjects will be enrolled in long-term use study



Biospecimen Retention:   None Retained

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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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548949


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Korea, Republic of
Chungbuk National University Hospital Terminated
Cheongju-si, Chungcheonbuk-do, Korea, Republic of, 362-711
Konkuk University Chungju Hospital / Department of Psychiatry Recruiting
Chungju-si, Chungcheongbuk-do, Korea, Republic of, 27376
Hallym University Dongtan Sacred Heart Hospital/Department of Neuropsychiatry Recruiting
Hwaseong-si, Gyeonggi Province, Korea, Republic of, 18450
Hallym University Sacred Heart Hospital Recruiting
Anyang-Si, Gyeonggi-do, Korea, Republic of, 431-796
Roa Neurology Clinic/Neurology Recruiting
Bundang-gu, Seongnam-si, Gyeonggi-do, Korea, Republic of, 13618
Inje University Ilsan Paik Hospital Active, not recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 411-706
Bundang Cha Medical Center Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
Bong Seng Memorial Hospital Recruiting
Busan, Korea, Republic of, 601-723
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 602-739
Kyungpook National University Hospital Terminated
Daegu, Korea, Republic of, 700-721
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of, 301-721
Chungnam National University Hospital Active, not recruiting
Daejeon, Korea, Republic of, 301-721
Chuncheon Sacred Heart Hospital-Hallym University Active, not recruiting
Gangwon-do, Korea, Republic of, 24253
Chosun University Hospital Recruiting
Gwangju, Korea, Republic of, 61453
Chonnam National University Hospital Active, not recruiting
Gwangju, Korea, Republic of, 61469
Presbyterian Medical Center Terminated
Jeonju, Korea, Republic of, 560-750
Nowon Eulji Medical Center, Eulji University Active, not recruiting
Seoul, Korea, Republic of, 01830
Korea University Anam Hospital Terminated
Seoul, Korea, Republic of, 02841
Seoul National University Hospital Active, not recruiting
Seoul, Korea, Republic of, 03080
Hanyang University Seoul Hospital Active, not recruiting
Seoul, Korea, Republic of, 04763
Chung-Ang University Hospital Terminated
Seoul, Korea, Republic of, 06973
Konkuk University Medical Center Terminated
Seoul, Korea, Republic of, 143-729
Kyung Hee University Hospital at Gangdong Department of Psychiatry Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02548949     History of Changes
Other Study ID Numbers: B2061143
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.
Additional relevant MeSH terms:
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Desvenlafaxine Succinate
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs