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Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury

NCT00735670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-10-13

Study results available
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Summary

This study was initially designed to test the efficacy of Venlafaxine HCl in reducing incidence of the onset of major depression after a new spinal cord injury (SCI). After several protocol modifications, the purpose of the study is to test the effectiveness of a sub-therapeutic dose of Venlafaxine HCl to reduce mild to moderate symptoms in persons with SCI.

Conditions

  • Spinal Cord Injury

Interventions

DRUG

Venlafaxine HCl

Starting dose is 37.5 mg and ending dose is 150 mg at 13 weeks. From weeks 13 to 26 subjects no longer will receive the drug

OTHER

Placebo

Subjects received a placebo instead of Venlafaxine HCl until week 13 as did the Venlafaxine group.

Sponsors & Collaborators

Principal Investigators

  • Denise G Tate, Ph.D. · University of Michigan Department of Physical Medicine and Rehabilitation

  • Anthony Chiodo, M.D. · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2012-06-30
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00735670 on ClinicalTrials.gov