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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177528
• Other study ID #: 000918
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: October 8, 2008
• Start date: October 2000

Study information

• Verified date: October 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• venlafaxine-XR

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety and tolerability of venlafaxine XR.
Primary	Rate of Major Depression remission to treatment.
Secondary	Participant characteristics that influence safety and remission rate.