NCT00177528

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

October 9, 2008

Status Verified

October 1, 2008

Enrollment Period

4.1 years

First QC Date

September 13, 2005

Last Update Submit

October 8, 2008

Conditions

Depression

Keywords

Elderly

Outcome Measures

Primary Outcomes (2)

  • The safety and tolerability of venlafaxine XR.

  • Rate of Major Depression remission to treatment.

Secondary Outcomes (1)

  • Participant characteristics that influence safety and remission rate.

Interventions

venlafaxine-XRDRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women of all races who are 60 years old or older;
  • a DSM-IV diagnosis of major depressive episode without psychotic features;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

October 1, 2000

Primary Completion

November 1, 2004

Last Updated

October 9, 2008

Record last verified: 2008-10

Locations

US(1)