Status:
COMPLETED
Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression
Lead Sponsor:
University of Pittsburgh
Conditions:
Depression
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
This research study is to evaluate the safety and usefulness of venlafaxine-XR in the treatment of major depression in the elderly.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00177528
Start Date
October 1 2000
Last Update
October 9 2008
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213