Sertraline vs. Placebo for Symptoms Following Traumatic Brain Injury

This study is currently recruiting participants.

Verified by Walter Reed Army Medical Center, October 2007

First Received: September 13, 2005 Last Updated: October 9, 2007 History of Changes

Sponsor:	Walter Reed Army Medical Center
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 James A. Haley VA Medical Center, Tampa Wilford Hall Medical Center
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00208585

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:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Placebo-Controlled Trial of Sertraline for the Neurobehavioral Sequelae of Traumatic Brain Injury

Resource links provided by NLM:

MedlinePlus related topics: Depression Traumatic Brain Injury

Drug Information available for: Sertraline hydrochloride Sertraline

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

James A. Haley VA Medical Center, Tampa

Wilford Hall Medical Center

Investigators

Study Director:

Michael Jaffee, MD

The Defense and Veterans Brain Injury Center

More Information

No publications provided

Study ID Numbers:	00-7102
Study First Received:	September 13, 2005
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00208585 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Craniocerebral Trauma
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Wounds and Injuries
Psychotropic Drugs
Central Nervous System Diseases
Disorders of Environmental Origin

Trauma, Nervous System
Brain Diseases
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Sertraline
Brain Injuries
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010