Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2004

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.

Intervention(s) in this Clinical Trial

• Drug: venlafaxine-XR

Primary Measures

• The safety and tolerability of venlafaxine XR.
• Rate of Major Depression remission to treatment.

Secondary Measures

• Participant characteristics that influence safety and remission rate.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Ellen M Whyte, MD Principal Investigator University of Pittsburgh  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00177528

Study ID Number: 000918

ClinicalTrials.gov Identifier: NCT00177528

Health Authority: United States: Institutional Review Board