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Traumatic Brain Injury | Sertraline vs. Placebo for Symptoms Following Traumatic Brain Injury

Traumatic Brain Injury research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic Brain Injury

Study Interventions

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:sertraline

Study Arms

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.

Study Status

Unknown status

Start Date: February 2000

Completed Date: December 2007

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Gouvier-PCSC

Secondary Outcome: Smell Identification Test

Study sponsors, principal investigator, and references

Principal Investigator: Michael Jaffee, MD

Lead Sponsor: Walter Reed Army Medical Center

Collaborator: The Defense and Veterans Brain Injury Center

More information:https://clinicaltrials.gov/show/NCT00208585

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