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

• ClinicalTrials.gov Identifier: NCT02548949
• Recruitment Status: Completed
• First Posted: September 14, 2015
• Results First Posted: February 9, 2021
• Last Update Posted: February 9, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: July 16, 2015
• First Posted Date: September 14, 2015
• Results First Submitted Date: January 21, 2021
• Results First Posted Date: February 9, 2021
• Last Update Posted Date: February 9, 2021
• Actual Study Start Date: April 25, 2016
• Actual Primary Completion Date: February 12, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 21, 2021)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 8 weeks ]
  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.
• Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: At Week 8 ]
  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.
• Number of Participants With Final Effectiveness Evaluation [ Time Frame: At Week 8 ]
  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.

Original Primary Outcome Measures (submitted: September 10, 2015)

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

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: September 10, 2015)

• 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
• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

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)".

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 21, 2021): 700
• Original Estimated Enrollment (submitted: September 10, 2015): 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:

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

Sex/Gender

• Sexes Eligible for Study: All

• 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

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

• 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.

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: January 2021