Pharmacological Intervention in Depression After Traumatic Brain Injury

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205491
• Other study ID #: H133A02051602
• Secondary ID: H133A020516
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: March 16, 2017
• Start date: October 2004
• Est. completion date: September 2007

Study information

• Verified date: March 2017
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Depression
• TBI (Traumatic Brain Injury)
• Wounds and Injuries

Intervention

Drug:
• Venlafaxine

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Hamilton Rating Scale for Depression (Ham-D)at 12 weeks.
Secondary	Scores on cognitive and psychomotor tests at 12 weeks.
Secondary	Scores on a satisfaction with life measure and a functional measure at 12 weeks.