NCT00208585

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 10, 2007

Status Verified

October 1, 2007

First QC Date

September 13, 2005

Last Update Submit

October 9, 2007

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (5)

  • Gouvier-PCSC

  • Post Concussive Scale

  • Hamilton Depression Scale

  • Montgomery Asberg Depression Rating

  • Diagnosis of PCD by DSM-IV

Secondary Outcomes (1)

  • Smell Identification Test

Interventions

sertralineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Contraindication to the use of sertraline.
  • Pregnancy
  • Current active suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20012, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Michael Jaffee, MD

    The Defense and Veterans Brain Injury Center

    STUDY DIRECTOR

Central Study Contacts

Michael Jaffee, MD

CONTACT

202-782-6345michael.jaffee@amedd.army.mil

Leslie Shupenko, MS

CONTACT

202-782-3081leslie.shupenko@amedd.army.mil

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

February 1, 2000

Study Completion

December 1, 2007

Last Updated

October 10, 2007

Record last verified: 2007-10

Locations

US(1)