Sertraline vs. Placebo for Symptoms Following Traumatic Brain Injury

Status unconfirmed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT00208585

Run by

Walter Reed Army Medical Center

People needed

100

Starts

2000-02-01

Expected to finish

2007-12-01

Last updated by the study team

2007-10-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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