Pharmacological Intervention in Depression After Traumatic Brain Injury

Virginia Commonwealth University (VCU)

Status and phase

Completed

Phase 4

Conditions

TBI (Traumatic Brain Injury)

Treatments

Drug: Venlafaxine

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00205491

H133A020516

H133A02051602

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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