Pharmacological Intervention in Depression After Traumatic Brain Injury
This study has been completed.
Sponsor:
Virginia Commonwealth University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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
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:
|
Depression Depressive Disorder Brain Injuries Behavioral Symptoms Mood Disorders Mental Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries 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 May 21, 2013