Study Evaluating Venlafaxine Extended Release in Elderly Depressed Patients

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NCT00247429

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depressive Syndrome, Anxiety
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients older than 60 years

- Depressive syndrome with associated anxiety symptoms, according to a symptoms intensity HAM-D17³14

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Depressive Syndrome, AnxietyStudy Evaluating Venlafaxine Extended Release in Elderly Depressed Patients
NCT00247429
ALL GENDERS
60 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Study Evaluating Venlafaxine Extended Release in Elderly Depressed Patients
Official Title Vandral Retard (Venlafaxine Extended Release) in Depressive Syndrome With Anxiety and Painful Symptoms in Elderly Patients. Observational Study in Primary Care
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
No specimen retained
Sampling Method Non-Probability Sample
Study Population Primary care centers
Condition
  • Depressive Syndrome
  • Anxiety
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 31, 2009)		59
Original Enrollment
 (submitted: October 28, 2005)		150
Actual Study Completion Date October 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00247429
Other Study ID Numbers 101356
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Principal Investigator:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009