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

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177528
First received: September 13, 2005
Last updated: October 8, 2008
Last verified: October 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

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
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

No publications provided

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

Keywords provided by University of Pittsburgh:
Elderly

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013