Sertraline vs. Placebo for Symptoms Following Traumatic Brain Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Walter Reed Army Medical Center.
Recruitment status was  Recruiting
The Defense and Veterans Brain Injury Center
Minneapolis Veterans Affairs Medical Center
VA Palo Alto Health Care System
Hunter Holmes McGuire VA Medical Center
United States Naval Medical Center, San Diego
Wilford Hall Medical Center
Information provided by:
Walter Reed Army Medical Center Identifier:
First received: September 13, 2005
Last updated: October 9, 2007
Last verified: October 2007

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.

Condition Intervention
Traumatic Brain Injury
Drug: sertraline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled Trial of Sertraline for the Neurobehavioral Sequelae of Traumatic Brain Injury

Resource links provided by NLM:

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • Gouvier-PCSC
  • Post Concussive Scale
  • Hamilton Depression Scale
  • Montgomery Asberg Depression Rating
  • Diagnosis of PCD by DSM-IV

Secondary Outcome Measures:
  • Smell Identification Test

Estimated Enrollment: 100
Study Start Date: February 2000
Estimated Study Completion Date: December 2007
  Show Detailed Description


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00208585

Contact: Michael Jaffee, MD 202-782-6345
Contact: Leslie Shupenko, MS 202-782-3081

United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20012
Contact: Angela M Bastolla, BS    202-782-3081   
Contact: Karen Schwab, PhD    202-782-3132   
Principal Investigator: Deborah L Warden, MD         
Sponsors and Collaborators
Walter Reed Army Medical Center
The Defense and Veterans Brain Injury Center
Minneapolis Veterans Affairs Medical Center
VA Palo Alto Health Care System
Hunter Holmes McGuire VA Medical Center
United States Naval Medical Center, San Diego
Wilford Hall Medical Center
Study Director: Michael Jaffee, MD The Defense and Veterans Brain Injury Center
  More Information

No publications provided Identifier: NCT00208585     History of Changes
Other Study ID Numbers: 00-7102
Study First Received: September 13, 2005
Last Updated: October 9, 2007
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses processed this record on August 27, 2015