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Sertraline vs. Placebo for Symptoms Following Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00208585
Recruitment Status : Unknown
Verified October 2007 by Walter Reed Army Medical Center.
Recruitment status was:  Recruiting
First Posted : September 21, 2005
Last Update Posted : October 10, 2007
Information provided by:

Study Description
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 relationship between irritability and aggression and anosmia in individuals who have suffered a traumatic brian injury.

Condition or disease Intervention/treatment
Traumatic Brain Injury Drug: sertraline

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled Trial of Sertraline for the Neurobehavioral Sequelae of Traumatic Brain Injury
Study Start Date : February 2000
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Gouvier-PCSC
  2. Post Concussive Scale
  3. Hamilton Depression Scale
  4. Montgomery Asberg Depression Rating
  5. Diagnosis of PCD by DSM-IV

Secondary Outcome Measures :
  1. Smell Identification Test

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208585

Contact: Michael Jaffee, MD 202-782-6345 michael.jaffee@amedd.army.mil
Contact: Leslie Shupenko, MS 202-782-3081 leslie.shupenko@amedd.army.mil

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    angela.bastolla@amedd.army.mil   
Contact: Karen Schwab, PhD    202-782-3132    karen.schwab@amedd.army.mil   
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
VA Office of Research and Development
Wilford Hall Medical Center
Study Director: Michael Jaffee, MD The Defense and Veterans Brain Injury Center
More Information

ClinicalTrials.gov Identifier: NCT00208585     History of Changes
Other Study ID Numbers: 00-7102
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 10, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs