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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Venlafaxine Hydrochloride

Criteria

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.