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.
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Jeffrey S. Kreutzer, PhD||Virginia Commonwealth University|