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

Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: venlafaxine-XR (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Ellen M Whyte, MD, Principal Investigator, Affiliation: University of Pittsburgh
Benoit H Mulsant, MD, Principal Investigator, Affiliation: University of Pittsburgh
Charles F. Reynolds III, MD, Principal Investigator, Affiliation: University of Pittsburgh

Summary

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

Clinical Details

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

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

Primary outcome:

The safety and tolerability of venlafaxine XR.

Rate of Major Depression remission to treatment.

Secondary outcome: Participant characteristics that influence safety and remission rate.

Detailed 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.

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States
Additional Information

Starting date: October 2000
Last updated: October 8, 2008

Page last updated: August 23, 2015

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