NCT01849432

Brief Summary

A diverse body of research has implicated the amygdalo-cortical circuitry in the pathophysiology of anxiety disorders. For example, one model of PTSD posits exaggerated amygdala responsivity to threat-related stimuli as well as deficient top-down modulation of amygdala responses by specific cortical regions, including the pregenual anterior cingulate cortex, subcallosal cortex, and hippocampus. The investigators propose to investigate the pathophysiology of several specific anxiety disorders, Posttraumatic Stress Disorder (PTSD), Panic Disorder (PD), and Specific Phobia(SP), by using cognitive activation paradigms and magnetic resonance imaging (MRI) to probe the function and structure of implicated amygdalo-cortical circuitry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

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

December 1, 2006

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
Last Updated

May 8, 2013

Status Verified

May 1, 2013

Enrollment Period

4.6 years

First QC Date

April 26, 2013

Last Update Submit

May 7, 2013

Conditions

Posttraumatic Stress DisorderPanic DisorderSpecific Phobias

Outcome Measures

Primary Outcomes (1)

  • amygdala activation during Masked Affect Task

    measured once at fMRI session

Study Arms (4)

Control

Healthy Controls

Posttraumatic Stress Disorder

Participants with Posttraumatic Stress Disorder

Panic Disorder

Participants with Panic Disorder

Specific Phobia

Participants who have specific phobias

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Boston metropolitan area

You may qualify if:

  • years of age
  • Right-handed (Edinburgh Inventory - Oldfield 1971)
  • SCID diagnosis consistent with group designation:
  • Current PTSD (PTSD group; none current or past (NC and TENC group); Current SP (must be to small animal phobia, SP group); Current PD (PD group)
  • To be matched for age, gender, and years of education, as well as self-identified race/ethnicity.
  • For female subjects, stage of menstrual cycle will be ascertained by history (see appendix), and dates of fMRI acquisition will be scheduled to prevent systematic differences between groups with respect to this variable.

You may not qualify if:

  • Neurologic or medical condition that would interfere with study procedures or confound results, ascertained by history.
  • History of seizure or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion)
  • Use of psychotropic medication within 4 weeks prior to study (within 6 weeks for fluoxetine, or other long-lived compounds; within one year for neuroleptics).
  • Pregnancy (to be ruled out by urine ß-HCG).
  • Metallic implants or devices contraindicating magnetic resonance imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (3)

  • Rosso IM, Makris N, Britton JC, Price LM, Gold AL, Zai D, Bruyere J, Deckersbach T, Killgore WD, Rauch SL. Anxiety sensitivity correlates with two indices of right anterior insula structure in specific animal phobia. Depress Anxiety. 2010 Dec;27(12):1104-10. doi: 10.1002/da.20765.

    PMID: 21132846RESULT

  • Killgore WD, Britton JC, Price LM, Gold AL, Deckersbach T, Rauch SL. Neural correlates of anxiety sensitivity during masked presentation of affective faces. Depress Anxiety. 2011 Mar;28(3):243-9. doi: 10.1002/da.20788. Epub 2011 Feb 9.

    PMID: 21308886RESULT

  • Britton JC, Gold AL, Deckersbach T, Rauch SL. Functional MRI study of specific animal phobia using an event-related emotional counting stroop paradigm. Depress Anxiety. 2009;26(9):796-805. doi: 10.1002/da.20569.

    PMID: 19434621RESULT

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticPanic DisorderPhobia, Specific

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersAnxiety Disorders

Study Officials

  • Scott L Rauch, MD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President, Psychiatrist in Chief

Study Record Dates

First Submitted

April 26, 2013

First Posted

May 8, 2013

Study Start

December 1, 2006

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 8, 2013

Record last verified: 2013-05

Locations

US(1)