Traumatic Brain Injury | Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury
Traumatic Brain Injury research study
What is the primary objective of this study?
The purpose of this study is to examine the efficacy of sertraline to prevent the onset of mood and anxiety disorders during the first six months after traumatic brain injury.
Who is eligible to participate?
Inclusion Criteria: - Age 18 years or over. - Meeting the Center for Disease Control (CDC) criteria for TBI. - Mild, Moderate, or Severe TBI as categorized by initial Glasgow Coma Scale (GCS) scores 13 to 15, 9 to 12, or 3 to 8, respectively. - Complete recovery from Post Traumatic Amnesia (PTA) within 4 weeks of the traumatic episode. Exclusion Criteria: - Penetrating head injuries. - Clinical or neuro-radiological evidence of associate spinal cord injury. - Patients with severe comprehension deficits (i.e., those who are not able to complete part II of the Token Test) that precludes a thorough neuropsychiatric evaluation. - Presence of Diagnostic and Statistical Manual IV defined mood, anxiety or psychotic disorder at the time of enrollment to the study. However, patients with a history of alcohol abuse or alcohol dependence during the year preceding TBI will be included in the study. - Patients who were taking antidepressants at the time of TBI or during a six month period prior to the traumatic event. - Patients who have failed an adequate previous trial with sertraline or had side effects that prompted the discontinuation of this medication. - Pregnant women or women that plan to become pregnant during the period of the study. - Severe complicating illness such as neoplastic disease or uncompensated heart, renal or liver failure.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Traumatic Brain Injury
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Placeboan inactive substance
Drug:SertralineSertraline and placebo will be given in a double blind fashion via an equal number of identical tablets administered once daily. Once stabilized in the targeted dosage (100 mg per day), sertraline serum levels will be monitored twice during the course of the intervention. Blood samples will be obtained randomly, one during the first and one during the second trimesters of the protocol.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PlaceboPlacebo will be given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
SertralineSertraline will be given in a double blind fashion via tablets administered once daily. Once stabilized in the targeted dosage (100 mg per day), sertraline serum levels will be monitored twice during the course of the intervention.
Start Date: June 2008
Completed Date: April 2014
Phase: Phase 2/Phase 3
Primary Outcome: Time to Onset of Diagnostic and Statistical Manual (DSM) IV Defined Mood and Anxiety Disorders Associated With Traumatic Brain Injury (TBI)
Secondary Outcome: Total Community Integration Questionnaire Scores
Study sponsors, principal investigator, and references
Principal Investigator: Ricardo E. Jorge, MD
Lead Sponsor: Baylor College of Medicine
Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
Arciniegas DB, Topkoff J, Silver JM. Neuropsychiatric Aspects of Traumatic Brain Injury. Curr Treat Options Neurol. 2000 Mar;2(2):169-186.