Pharmacological Intervention in Depression After Traumatic Brain Injury

Completed · Phase 4

Conditions studied: TBI (Traumatic Brain Injury)

In brief

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

Key facts

Study ID

NCT00205491

Run by

Virginia Commonwealth University

People needed

100

Starts

2004-10-01

Expected to finish

2007-09-01

Last updated by the study team

2017-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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