Sertraline vs. Placebo for Symptoms Following Traumatic Brain Injury

• Status: Unknown status
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the efficacy of an SSRI, sertraline for the use of post-concussive symptoms following a traumatic brain injury. the study also seeks to investigate the relationship between irritability and aggression and anosmia in individuals who have suffered a traumatic brian injury.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Walter Reed Army Medical Center
• Collaborators: 59th Medical Wing; Hunter Holmes McGuire VA Medical Center; James A. Haley Veterans Administration Hospital; Minneapolis Veterans Affairs Medical Center; The Defense and Veterans Brain Injury Center; United States Naval Medical Center, San Diego; VA Office of Research and Development; VA Palo Alto Health Care System; Wilford Hall Medical Center
• Treatments: Sertraline

Criteria

Inclusion Criteria:

• Traumatic brain injury patients within 6 months of injury.

• Traumatic brain injury with:

• Minimum severity - TBI with post traumatic amnesia.

• Maximum severity - recovery to a Rancho los Amigos (see Appendix II) level 7 or 8 by six months after injury.

• The C Criterion of DSM IV diagnosis of Post Concussive Disorder (PCD- Research Criteria), with symptoms persisting for a minimum of 4 weeks.

• Military beneficiary.

Exclusion Criteria:

• Severe prior neurologic or psychiatric illness, such as stroke or psychosis. (Previous nonpsychotic depression is not an exclusion criterion)

• Contraindication to the use of sertraline.

• Previous severe traumatic brain injury (defined as TBI with period of unconsciousness greater than 1 week prior. This exclusion refers only to TBI's prior to the current injury, which is within the past 6 months).

• Pregnancy

• Current active suicidal ideation