- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247429
Study Evaluating Venlafaxine Extended Release in Elderly Depressed Patients
August 31, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
Vandral Retard (Venlafaxine Extended Release) in Depressive Syndrome With Anxiety and Painful Symptoms in Elderly Patients. Observational Study in Primary Care
In this study we will assess as a primary objective the effect of venlafaxine retard treatment on primary care attended elderly patients with depressive syndrome.
We will also study secondarily its effects on anxiety, somatic and painful symptoms of depression.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
59
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary care centers
Description
Inclusion Criteria:
- Patients older than 60 years
- Depressive syndrome with associated anxiety symptoms, according to a symptoms intensity HAM-D17³14
Exclusion Criteria:
- Participation in other studies in the last 3 months before the start of the study
- Known hypersensibility to venlafaxine
- Clinically significant abnormalities according to the venlafaxine labeling
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
October 1, 2005
Study Registration Dates
First Submitted
October 28, 2005
First Submitted That Met QC Criteria
October 28, 2005
First Posted (Estimate)
November 1, 2005
Study Record Updates
Last Update Posted (Estimate)
September 1, 2009
Last Update Submitted That Met QC Criteria
August 31, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101356
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.