Status:
COMPLETED
Pharmacological Intervention in Depression After Traumatic Brain Injury
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
U.S. Department of Education
Conditions:
TBI (Traumatic Brain Injury)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if treatment with venlafaxine reduces symptoms of depression in persons with traumatic brain injury.
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00205491
Start Date
October 1 2004
End Date
September 1 2007
Last Update
March 17 2017
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298