Status:
UNKNOWN
Sertraline vs. Placebo for Symptoms Following Traumatic Brain Injury
Lead Sponsor:
Walter Reed Army Medical Center
Collaborating Sponsors:
The Defense and Veterans Brain Injury Center
Minneapolis Veterans Affairs Medical Center
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 rela...
Detailed Description
The objectives of this protocol are the following: 1. To investigate the efficacy of sertraline, a selective serotonin reuptake inhibitor (SSRI), in treating neurobehavioral sequelae of irritability,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00208585
Start Date
February 1 2000
End Date
December 1 2007
Last Update
October 10 2007
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20012