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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: May 12, 2011
Last updated: January 9, 2015
Last verified: January 2015
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.

Condition Intervention Phase
Major Depressive Disorder
Vasomotor Symptoms
Drug: desvenlafaxine succinate
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety assessments as measured by evaluating any reported adverse events, scheduled physical examinations and vital signs assessments. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Drug: desvenlafaxine succinate
50 mg tablet once daily
Other Name: Pristiq

Detailed Description:
post marketing surveillance none

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate

Inclusion Criteria:

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

Exclusion Criteria:

Hypersensitivity to desvenlafaxine succinate

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01353963

Private Clinic
Las Pinas, Philippines
Private Clinic
Manila, Philippines
Private Clinic
Pasay City, Philippines
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01353963     History of Changes
Other Study ID Numbers: B2061038
Study First Received: May 12, 2011
Last Updated: January 9, 2015
Health Authority: Philippines: Food and Drug Administration (FDA)

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses processed this record on November 30, 2015