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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
Sponsor:
Collaborators:
The Defense and Veterans Brain Injury Center
Minneapolis Veterans Affairs Medical Center
VA Palo Alto Health Care System
Hunter McGuire VA Medical System, Richmond
United States Naval Medical Center, San Diego
Department of Veterans Affairs
Wilford Hall Medical Center
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00208585
First received: September 13, 2005
Last updated: October 9, 2007
Last verified: October 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208585

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

Locations
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 McGuire VA Medical System, Richmond
United States Naval Medical Center, San Diego
Department of Veterans Affairs
Wilford Hall Medical Center
Investigators
Study Director: Michael Jaffee, MD The Defense and Veterans Brain Injury Center
  More Information

No publications provided

ClinicalTrials.gov 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
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Sertraline
Antidepressive Agents
Psychotropic Drugs
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013