NCT00209040

Brief Summary

The current study will investigate the ability of people with and without fear symptoms after trauma to inhibit fear in an experimental situation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
425

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2001

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2012

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

11.1 years

First QC Date

September 14, 2005

Last Update Submit

August 5, 2019

Conditions

Posttraumatic Stress Disorder

Keywords

PTSDAcoustic startle

Outcome Measures

Primary Outcomes (1)

  • Fear potentiation of acoustic startle

    Percent change in acoustic startle magnitude during visual cue conditioned to aversive stimuli, compared to trials without aversive stimuli

    Baseline

Study Arms (3)

1

EXPERIMENTAL

Subjects with posttraumatic stress disorder

Behavioral: Acoustic Startle Testing

2

ACTIVE COMPARATOR

Healthy controls

Behavioral: Acoustic Startle Testing

3

ACTIVE COMPARATOR

Combat controls

Behavioral: Acoustic Startle Testing

Interventions

Acoustic Startle TestingBEHAVIORAL

See protocol description for methodological details

123

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80
  • Diagnosis of PTSD
  • Healthy controls (no history of PTSD)
  • Combat controls (no history of PTSD)

You may not qualify if:

  • No drug or alcohol abuse or dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Erica Duncan, MD

    Emory University/Atlanta VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

January 1, 2001

Primary Completion

February 22, 2012

Study Completion

February 22, 2012

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)