Pharmacological Intervention in Depression After Traumatic Brain Injury
The purpose of this study is to determine if treatment with venlafaxine reduces symptoms of depression in persons with traumatic brain injury.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Pharmacological Intervention in Depression After Traumatic Brain Injury (A Research Study Within the Traumatic Brain Injury Model System)|
- Score on the Hamilton Rating Scale for Depression (Ham-D)at 12 weeks.
- Scores on cognitive and psychomotor tests at 12 weeks.
- Scores on a satisfaction with life measure and a functional measure at 12 weeks.
|Study Start Date:||October 2004|
|Study Completion Date:||September 2007|
The study evaluates the benefits of a promising antidepressant medication for the treatment of persons with traumatic brain injury (TBI) and major depressive disorder (MDD). The study is a randomized, double-blind, placebo-controlled trial of venlafaxine (a serotonin and norepinephrine reuptake inhibitor, also known as Effexor). Venlafaxine has been well established in the treatment of MDD in healthy individuals and is a recommended depression treatment agent for persons with TBI. By using a rigorous scientific methodology, this study will be an important first step in advancing the treatment of depression in this population beyond general impressions to proven treatments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205491
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Jeffrey S. Kreutzer, PhD||Virginia Commonwealth University|