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Trial record 4 of 6 for:    "Brain Injury" | "Norepinephrine"

Pharmacological Intervention in Depression After Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00205491
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 17, 2017
U.S. Department of Education
Information provided by (Responsible Party):
Virginia Commonwealth University

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

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Drug: Venlafaxine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Pharmacological Intervention in Depression After Traumatic Brain Injury (A Research Study Within the Traumatic Brain Injury Model System)
Study Start Date : October 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Score on the Hamilton Rating Scale for Depression (Ham-D)at 12 weeks.

Secondary Outcome Measures :
  1. Scores on cognitive and psychomotor tests at 12 weeks.
  2. Scores on a satisfaction with life measure and a functional measure at 12 weeks.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00205491

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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
U.S. Department of Education
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Principal Investigator: Jeffrey S. Kreutzer, PhD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University Identifier: NCT00205491     History of Changes
Other Study ID Numbers: H133A02051602
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017
Keywords provided by Virginia Commonwealth University:
depression after brain injury
traumatic brain injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Serotonin and Noradrenaline Reuptake Inhibitors
Wounds and Injuries
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Venlafaxine Hydrochloride
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs