Pharmacological Intervention in Depression After Traumatic Brain Injury

Pharmacological Intervention in Depression After Traumatic Brain Injury (A Research Study Within the Traumatic Brain Injury Model System)

The purpose of this study is to determine if treatment with venlafaxine reduces symptoms of depression in persons with traumatic brain injury.

Study Overview

• Status: Completed
• Conditions: TBI (Traumatic Brain Injury)
• Intervention / Treatment: Drug: Venlafaxine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must have a documented traumatic brain injury (TBI), defined as damage to brain tissue caused by an external mechanical force as evidenced by: loss of consciousness due to brain trauma, or post traumatic amnesia (PTA), or skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.
• Age 18 years or older
• At least three months postinjury
• Presence of major depressive disorder (MDD), as defined by Structured Clinical Interview for DSM-IV (SCID) interview
• Hamilton Depression Rating Scale (Ham-D) scores of 18 or greater on two consecutive evaluations (screening and baseline)

Exclusion Criteria:

• Individuals under 18 years of age
• Pregnancy, as determined by urine pregnancy screen
• Prisoners
• Individuals who are institutionalized
• Individuals who are not cognitively capable of completing the SCID interview and the Ham-D
• Unstable medical condition, defined as any significant medical condition likely to require hospitalization during the study period, or requiring adjustment in medications in the past month
• Active suicidality
• Severe depression that, in the investigator's professional opinion, will likely require hospitalization during the study time period
• Diagnosis of bipolar disorder, as defined by SCID interview
• Diagnosis of schizophrenia or other psychotic disorder, as defined by SCID interview, other than major depression with psychotic features
• Active drug or alcohol abuse within the past 3 months, as defined by SCID interview
• Dysphagia sufficient to preclude use of oral medications
• Known hypersensitivity to venlafaxine
• Use of monamine oxidase inhibitors (MAOI) within the past month
• Treatment with antidepressant medication within the past 3 months
• Concomitant administration of medications that interact with venlafaxine to a clinically significant degree

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Score on the Hamilton Rating Scale for Depression (Ham-D)at 12 weeks.

Secondary Outcome Measures

Outcome Measure
Scores on cognitive and psychomotor tests at 12 weeks.
Scores on a satisfaction with life measure and a functional measure at 12 weeks.

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: U.S. Department of Education
• Investigators: Principal Investigator: Jeffrey S. Kreutzer, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: traumatic brain injury; Venlafaxine; depression after brain injury
• Additional Relevant MeSH Terms: Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Depression; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: H133A02051602; H133A020516 (NIDRR)