Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression - Full Text View

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177528

Purpose

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

Condition	Intervention	Phase
Depression	Drug: venlafaxine-XR	Phase IV

MedlinePlus related topics: Depression

Drug Information available for: Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Participant characteristics that influence safety and remission rate.

Estimated Enrollment:	70
Study Start Date:	October 2000
Estimated Study Completion Date:	December 2008
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177528

Locations

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

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:	Ellen M Whyte, MD	University of Pittsburgh
Principal Investigator:	Benoit H Mulsant, MD	University of Pittsburgh
Principal Investigator:	Charles F. Reynolds III, MD	University of Pittsburgh

More Information

Study ID Numbers:	000918
Study First Received:	September 13, 2005
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00177528
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Elderly

Study placed in the following topic categories:

Depression
Mental Disorders
Venlafaxine
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Serotonin Uptake Inhibitors
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009