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

NCT ID: NCT00177528

Last Updated: 2008-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Depression

Keywords

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Elderly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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venlafaxine-XR

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Principal Investigators

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Ellen M Whyte, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Benoit H Mulsant, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Charles F. Reynolds III, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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000918

Identifier Type: -

Identifier Source: org_study_id