NCT00247429

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2004

Status
completed

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

Study Start

First participant enrolled

July 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
Last Updated

September 1, 2009

Status Verified

August 1, 2009

Enrollment Period

1.3 years

First QC Date

October 28, 2005

Last Update Submit

August 31, 2009

Conditions

Depressive SyndromeAnxiety

Keywords

depressionanxietyelderly

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care centers

You may qualify if:

  • Patients older than 60 years
  • Depressive syndrome with associated anxiety symptoms, according to a symptoms intensity HAM-D17³14

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: NONE RETAINED

No specimen retained

MeSH Terms

Conditions

Depressive DisorderAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 28, 2005

First Posted

November 1, 2005

Study Start

July 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

September 1, 2009

Record last verified: 2009-08