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

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.