Major Depressive DisorderPMSNCT02548949

Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ

An observational study of Major Depressive Disorder, run by Pfizer at 22 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: Major Depressive Disorder
How many people: 700 participants
Where: 22 sitesSouth Korea
Study dates: 25 Apr 2016to 12 Feb 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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'

Who cannot join

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

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

South Korea22 sites

Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 431-796
Roa Neurology Clinic/Neurology
Bundang-gu, Seongnam-si, Gyeonggi-do, 13618
Bong Seng Memorial Hospital
Busan, 601-723
Pusan National University Hospital
Busan, 602-739
Chungbuk National University Hospital
Cheongju-si, Chungcheonbuk-do, 362-711
Konkuk University Chungju Hospital / Department of Psychiatry
Chungju, North Chungcheong, 27376
Kyungpook National University Hospital
Daegu, 700-721
Chungnam National University Hospital
Daejeon, 301-721
Chuncheon Sacred Heart Hospital-Hallym University
Gangwon-do, 24253
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, 411-706
Chosun University Hospital
Gwangju, 61453
Chonnam National University Hospital
Gwangju, 61469
Hallym University Dongtan Sacred Heart Hospital/Department of Neuropsychiatry
Hwaseong-si, Gyeonggi Province, 18450
Presbyterian Medical Center
Jeonju, 560-750
Bundang Cha Medical Center
Seongnam-si, Gyeonggi-do, 13496
Nowon Eulji Medical Center, Eulji University
Seoul, 01830
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Hanyang University Seoul Hospital
Seoul, 04763
Chung-Ang University Hospital
Seoul, 06973
Konkuk University Medical Center
Seoul, 143-729
Kyung Hee University Hospital at Gangdong Department of Psychiatry
Seoul

Other trials in South Korea

About this study

Official title: 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.

Read the 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)".

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

Conditions: Major Depressive Disorder
Medical subject headings: Depressive Disorder, Major

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: At Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 201612 Feb 2020

First posted14 Sep 2015 (estimated)
Study start25 Apr 2016
Primary completion12 Feb 2020
Study completion12 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 700 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02548949
Sponsor's protocol ID: B2061143
Acronym: PMS
Status last verified: Jan 2021
First submitted: 16 Jul 2015
Last updated: 9 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: 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.

Publications

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.
PubMed 35879039

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: KOREAN POST MARKETING SURVEILLANCE TO OBSERVE EFFECTIVENESS AND SAFETY OF PRISTIQ (REGISTERED) IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER.
ClinicalTrials.gov ID: NCT02548949
Acronym / sponsor ID: PMS / B2061143
Conditions: Major Depressive Disorder
Study type: Observational
Recruitment status: Completed
Enrolment: 700 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 25 Apr 2016 (actual)
Primary completion: 12 Feb 2020 (actual)
Study completion: 12 Feb 2020 (actual)
First posted: 14 Sep 2015 (estimated)
Results: Posted 9 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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'

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

Results and safety

Results posted to the registry on 9 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pristiq	700	700

Primary outcome: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Up to 8 weeks. Count of participants. Unit: Participants

Measure	Pristiq n = 700
AEs	80
SAEs	3

Population analysed: Safety analysis set included all participants who had been administered Pristiq at least once and completed follow up.

Primary outcome: Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale

Time frame: At Week 8. Count of participants. Unit: Participants

Measure	Pristiq n = 454
Very much improved	22
Much improved	128
Minimally improved	237
No change	65
Minimally worse	2
Much worse	0
Very much worse	0

Population analysed: 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.

Primary outcome: Number of Participants With Final Effectiveness Evaluation

Time frame: At Week 8. Count of participants. Unit: Participants

Measure	Pristiq n = 479
Improved	411
No change	68
Worse	0
Unevaluable	0

Population analysed: 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.

Adverse events

Time frame: Up to 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pristiq	3 of 700 (0.4%)	80 of 700 (11.4%)	0 of 700

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35879039Roh 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Disorder, run by Pfizer at 22 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02548949, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.