Pharmacological Intervention in Depression After Traumatic Brain Injury

NCT ID: NCT00205491

Last Updated: 2017-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2007-09-30

Brief Summary

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

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.

Conditions

TBI (Traumatic Brain Injury)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Venlafaxine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Department of Education

FED

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey S. Kreutzer, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

H133A020516

Identifier Type: -

Identifier Source: secondary_id

H133A02051602

Identifier Type: -

Identifier Source: org_study_id