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Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Chungbuk National University Hospital
Cheongju-si, Chungcheonbuk-do, 362-711 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT02548949
Pfizer
Recruiting
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
Korean Post Marketing Surveillance To Observe Effectiveness And Safety Of Pristiq (Registered) In Patients With Major Depressive Disorder.
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)".

  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
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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.

Non-Probability Sample
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.
Major Depressive Disorder
Not Provided
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Korea, Republic of
 
 
NCT02548949
B2061143
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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