NCT01353963

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 18, 2016

Completed
Last Updated

January 18, 2016

Status Verified

December 1, 2015

Enrollment Period

5 months

First QC Date

May 12, 2011

Results QC Date

December 4, 2015

Last Update Submit

December 4, 2015

Conditions

Major Depressive DisorderVasomotor Symptoms

Outcome Measures

Primary Outcomes (7)

  • 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.

    Week 4 to Week 8

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

    Week 4

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

    Week 8

  • Change From Baseline in Heart Rate at Week 4.

    Week 4

  • Change From Baseline in Heart Rate at Week 8.

    Week 8

  • Change From Baseline in Weight at Week 4.

    Week 4

  • Change From Baseline in Weight at Week 8.

    Week 8

Study Arms (1)

1

Drug: desvenlafaxine succinate

Interventions

desvenlafaxine succinateDRUG

50 mg tablet once daily

Also known as: Pristiq
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Hypersensitivity to desvenlafaxine succinate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Private Clinic

Las Piñas, Philippines

Location

Private Clinic

Manila, Philippines

Location

Private Clinic

Pasay, Philippines

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticLipids

Limitations and Caveats

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.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
18007181021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 16, 2011

Study Start

March 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 18, 2016

Results First Posted

January 18, 2016

Record last verified: 2015-12

Locations

PH(3)