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
  Purpose

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


Condition Intervention Phase
TBI (Traumatic Brain Injury)
Drug: Venlafaxine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Pharmacological Intervention in Depression After Traumatic Brain Injury (A Research Study Within the Traumatic Brain Injury Model System)

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

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.

Estimated Enrollment: 100
Study Start Date: October 2004
Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205491

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00205491     History of Changes
Other Study ID Numbers: H133A02051602, H133A020516
Study First Received: September 12, 2005
Last Updated: October 23, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Virginia Commonwealth University:
depression after brain injury
traumatic brain injury
Venlafaxine

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Central Nervous System Diseases
Nervous System Diseases
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014