Pharmacological Intervention in Depression After Traumatic Brain Injury

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

Detailed Description
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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.

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

Conditions
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TBI (Traumatic Brain Injury)

Intervention / Treatment
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* Drug: Venlafaxine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Venlafaxine|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on cognitive and psychomotor tests at 12 weeks. |  |  | 
| Scores on a satisfaction with life measure and a functional measure at 12 weeks. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression after brain injury, traumatic brain injury, Venlafaxine