Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients

An observational study of Major Depressive Disorder and Vasomotor Symptoms, run by Pfizer at 3 sites in Philippines.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is a non-interventional study to review safety data on administration of desvenlafaxine succinate among Filipino patients with MDD and VMS per usual clinical practice within the first three years post commercial distribution. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Major Depressive Disorder, Vasomotor Symptoms
What is being tested?: desvenlafaxine succinate
Type of treatment: Pill or oral medicine
How many people: 13 participants
Where: 3 sitesPhilippines
Study dates: Mar 2012to Aug 2012
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate

Who may be able to join

Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate

Who cannot join

Hypersensitivity to desvenlafaxine succinate

Trial locations and contacts

3 sites in 1 country.

Philippines3 sites

Private Clinic
Las Piñas
Private Clinic
Manila
Private Clinic
Pasay

Other trials in Philippines

About this study

Official title: An Open Label, Non-interventional Study Of The Safety Of Desvenlafaxine Succinate (Pristiq) In The Treatment Of Major Depressive Disorder (Mdd) And Vasomotor Symptoms (Vms) Associated With Menopause In Filipino Adult Patients: A Post Marketing Surveillance Study

Read the detailed description

post marketing surveillance none

Conditions: Major Depressive Disorder, Vasomotor Symptoms
Being tested: desvenlafaxine succinate
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

desvenlafaxine succinateDrug
Also called Pristiq
50 mg tablet once daily

Study groups in NCT01353963
Study group	Role	What they receive
1		Not described Receives: Drug: desvenlafaxine succinate

What is being measured

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

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with 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; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state.
Measured: Week 4 to Week 8
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.
Measured: Week 4
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.
Measured: Week 8
Change From Baseline in Heart Rate at Week 4.
Measured: Week 4
Change From Baseline in Heart Rate at Week 8.
Measured: Week 8
Change From Baseline in Weight at Week 4.
Measured: Week 4
Change From Baseline in Weight at Week 8.
Measured: Week 8

Timeline

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

Mar 2012Aug 2012

First posted16 May 2011 (estimated)
Study startMar 2012
Primary completionAug 2012
Study completionAug 2012

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.
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
Time perspective: Prospective
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01353963
Sponsor's protocol ID: B2061038
Status last verified: Dec 2015
First submitted: 12 May 2011
Last updated: 18 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Non-interventional Study Of The Safety Of Desvenlafaxine Succinate (Pristiq) In The Treatment Of Major Depressive Disorder (Mdd) And Vasomotor Symptoms (Vms) Associated With Menopause In Filipino Adult Patients: A Post Marketing Surveillance Study
ClinicalTrials.gov ID: NCT01353963
Acronym / sponsor ID: B2061038
Conditions: Major Depressive Disorder, Vasomotor Symptoms
Study type: Observational
Recruitment status: Terminated
Enrolment: 13 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 16 May 2011 (estimated)
Results: Posted 18 Jan 2016

Clinical summary

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

Detailed description

post marketing surveillance none

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	Drug: desvenlafaxine succinate

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate

Key inclusion criteria (1 listed)

Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate

Key exclusion criteria (1 listed)

Hypersensitivity to desvenlafaxine succinate

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

Interventions

Intervention	Type	Arms
desvenlafaxine succinateAlso: Pristiq50 mg tablet once daily	Drug	1

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)
Time frame: Week 4 to Week 8
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with 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; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state.
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.
Time frame: Week 4
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.
Time frame: Week 8
Change From Baseline in Heart Rate at Week 4.
Time frame: Week 4
Change From Baseline in Heart Rate at Week 8.
Time frame: Week 8
Change From Baseline in Weight at Week 4.
Time frame: Week 4
Change From Baseline in Weight at Week 8.
Time frame: Week 8

Results and safety

Results posted to the registry on 18 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Desvenlafaxine Succinate	13	11

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)

Time frame: Week 4 to Week 8. Number. Unit: Participants

Measure	Desvenlafaxine Succinate n = 13
Participants w ith AEs	5
Participants w ith SAEs	0
Participants discontinued due to AEs	2

Population analysed: Safety population included all participants who received at least 1 dose of study medication during the observation period.

Primary outcome: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.

Time frame: Week 4. Mean (Standard Deviation). Unit: millimeter of mercury (mmHg)

Measure	Desvenlafaxine Succinate n = 13
Change from baseline in systolic BP at Week 4	-0.5 (8.69)
Change from baseline in diastolic BP at Week 4	-0.5 (9.60)

Population analysed: Safety population included all participants who received at least 1 dose of study medication during the observation period.

Primary outcome: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.

Time frame: Week 8. Mean (Standard Deviation). Unit: millimeter of mercury (mmHg)

Measure	Desvenlafaxine Succinate n = 11
Change from baseline in systolic BP at Week 8	-0.7 (7.06)
Change from baseline in diastolic BP at Week 8	-1.8 (13.28)

Population analysed: Safety population included all participants who received at least 1 dose of study medication during the observation period.

Primary outcome: Change From Baseline in Heart Rate at Week 4.

Time frame: Week 4. Mean (Standard Deviation). Unit: beats per minute (bpm)

Measure	Desvenlafaxine Succinate n = 13
Value	1.9 (4.50)

Population analysed: Safety population included all participants who received at least 1 dose of study medication during the observation period.

Adverse events

Time frame: Week 4 to Week 8. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Desvenlafaxine Succinate	0 of 13 (0%)	5 of 13 (38.5%)	Not reported

Limitations and caveats (from the sponsor): Due to the low number of subjects with data available, only descriptive summaries have been presented. The outcomes measures were prioritized as per study team's discretion.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Major Depressive Disorder

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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

3 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 and Vasomotor Symptoms, run by Pfizer at 3 sites in Philippines.

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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Philippines. 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 18 Jan 2016). 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 Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) (time frame: Week 4 to Week 8). The study lists 7 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 NCT01353963.

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 18 Jan 2016.