Pharmacological Intervention in Depression After Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00205491
First received: September 12, 2005
Last updated: October 23, 2007
Last verified: October 2007

September 12, 2005
October 23, 2007
October 2004
Not Provided
Score on the Hamilton Rating Scale for Depression (Ham-D)at 12 weeks.
Same as current
Complete list of historical versions of study NCT00205491 on ClinicalTrials.gov Archive Site
  • Scores on cognitive and psychomotor tests at 12 weeks.
  • Scores on a satisfaction with life measure and a functional measure at 12 weeks.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
TBI (Traumatic Brain Injury)
Drug: Venlafaxine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205491
H133A02051602, H133A020516
Not Provided
Not Provided
Virginia Commonwealth University
U.S. Department of Education
Principal Investigator: Jeffrey S. Kreutzer, PhD Virginia Commonwealth University
Virginia Commonwealth University
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP