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Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177528
First received: September 13, 2005
Last updated: October 8, 2008
Last verified: October 2008
History of Changes

September 13, 2005
October 8, 2008
October 2000
November 2004   (final data collection date for primary outcome measure)
  • The safety and tolerability of venlafaxine XR.
  • Rate of Major Depression remission to treatment.
Same as current
Complete list of historical versions of study NCT00177528 on ClinicalTrials.gov Archive Site
Participant characteristics that influence safety and remission rate.
Same as current
 
 
 
Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression
Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression

This research study is to evaluate the safety and usefulness of venlafaxine-XR in the treatment of major depression in the elderly.

The primary objective of this pilot study is to evaluate the safety of venlafaxine extended release formulation (XR) in the treatment of geriatric non-psychotic depression. This pilot study's specific aims are to assess the safety of venlafaxine XR in the geriatric population, to estimate the response rate of older depressed subjects treated under open conditions and to evaluate pharmacokinetic characteristics that may impact on safety and outcome.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
Drug: venlafaxine-XR
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
 
November 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • men and women of all races who are 60 years old or older;
  • a DSM-IV diagnosis of major depressive episode without psychotic features;
  • 17-item Ham-D score of >15 for potential subjects who have not received any antidepressant treatment during this illness episode or HAM-D > 11 for potential subjects who have received treatment with an antidepressant (other than venlafaxine-XR) during this illness episode;
  • a MMSE score of >15.

Exclusion Criteria:

  • history of meeting DSM-IV criteria for mania, schizophrenia or other psychotic disorder;
  • history of substance abuse or dependence, including alcohol, within the last three months;
  • current hyponatremia (as defined as a serum sodium level < 130 meq/l);
  • untreated or uncontrolled hypertension;
  • a history of being unable to tolerate venlafaxine-XR or venlafaxine immediate release formulation;
  • history of receiving venlafaxine-XR or venlafaxine immediate release formulation of 6 or more weeks at 300mg/d during index depressive episode; (7) EKG revealing QTc > 480 msec;
  • myocardial infarction, unstable angina, palpitation or cardiogenic syncope within 3 months prior to entering this study;
  • the presence of active suicidal ideation with intent.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177528
000918
 
 
University of Pittsburgh
 
Principal Investigator: Ellen M Whyte, MD University of Pittsburgh
Principal Investigator: Benoit H Mulsant, MD University of Pittsburgh
Principal Investigator: Charles F. Reynolds III, MD University of Pittsburgh
University of Pittsburgh
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP