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Pharmacological Intervention in Depression After Traumatic Brain Injury

Primary Purpose

TBI (Traumatic Brain Injury)

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Venlafaxine
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for TBI (Traumatic Brain Injury) focused on measuring depression after brain injury, traumatic brain injury, Venlafaxine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
March 16, 2017
Sponsor
Virginia Commonwealth University
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT00205491
Brief Title
Pharmacological Intervention in Depression After Traumatic Brain Injury
Official Title
Pharmacological Intervention in Depression After Traumatic Brain Injury (A Research Study Within the Traumatic Brain Injury Model System)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
U.S. Department of Education

4. Oversight

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury)
Keywords
depression after brain injury, traumatic brain injury, Venlafaxine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Primary Outcome Measure Information:
Title
Score on the Hamilton Rating Scale for Depression (Ham-D)at 12 weeks.
Secondary Outcome Measure Information:
Title
Scores on cognitive and psychomotor tests at 12 weeks.
Title
Scores on a satisfaction with life measure and a functional measure at 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S. Kreutzer, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Pharmacological Intervention in Depression After Traumatic Brain Injury

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