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.