Posttraumatic Stress DisorderNCT01849432
Study of Brain Circuitry in Anxiety Disorders
An observational study of Posttraumatic Stress Disorder and Panic Disorder, run by Mclean Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Panic Disorder, Specific Phobias
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Boston metropolitan area
Who may be able to join
- 18 - 65 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.
Who cannot join
- 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)
- History of exclusionary Axis I psychiatric diagnosis (other than as specified); i.e., history of substance use disorder, psychotic disorder, bipolar disorder, tic disorder, or eating disorder. Note that comorbid current major depressive disorder will be allowed in up to one half of each study group. This will enable inclusion of this common comorbidity, but also enable a definitive assessment of whether or not the presence of this comorbid diagnosis is driving any observed significant between group differences.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probing Amygdalo-Cortical Circuitry in Anxiety Disorders
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.
Read the detailed description
All candidates for this project will undergo a comprehensive clinical assessment by an investigator trained to administer these instruments. At the MGH fMRI Center in Charlestown or at the Neuroimaging Center at McLean Hospital in Belmont, MA; each subject will undergo a single MRI session lasting approximately 2 hours. After the scanning session, subjects may be asked to make judgments about the facial expressions or the words that were presented.
- Medical subject headings
- Stress Disorders, Post-Traumatic, Panic Disorder, Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy Controls | |
| Posttraumatic Stress Disorder | Participants with Posttraumatic Stress Disorder | |
| Panic Disorder | Participants with Panic Disorder | |
| Specific Phobia | Participants who have specific phobias |
What is being measured
The primary outcome is the main question the study is designed to answer.
amygdala activation during Masked Affect Task
Measured: measured once at fMRI session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startDec 2006
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Rauch, Mclean Hospital
- Investigators
- Scott L Rauch, MD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849432
- Sponsor's protocol ID
- 1R01MH070730-01A2
- Status last verified
- May 2013
- First submitted
- 26 Apr 2013
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21132846Killgore 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.
PubMed 21308886Britton 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.
PubMed 19434621
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing Amygdalo-Cortical Circuitry in Anxiety Disorders
- ClinicalTrials.gov ID
- NCT01849432
- Acronym / sponsor ID
- 1R01MH070730-01A2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All candidates for this project will undergo a comprehensive clinical assessment by an investigator trained to administer these instruments. At the MGH fMRI Center in Charlestown or at the Neuroimaging Center at McLean Hospital in Belmont, MA; each subject will undergo a single MRI session lasting approximately 2 hours. After the scanning session, subjects may be asked to make judgments about the facial expressions or the words that were presented.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Healthy Controls |
| Posttraumatic Stress Disorder | – | –Participants with Posttraumatic Stress Disorder |
| Panic Disorder | – | –Participants with Panic Disorder |
| Specific Phobia | – | –Participants who have specific phobias |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Boston metropolitan area
Key inclusion criteria (6 listed)
- 18 - 65 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.
Key exclusion criteria (6 listed)
- 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)
- History of exclusionary Axis I psychiatric diagnosis (other than as specified); i.e., history of substance use disorder, psychotic disorder, bipolar disorder, tic disorder, or eating disorder. Note that comorbid current major depressive disorder will be allowed in up to one half of each study group. This will enable inclusion of this common comorbidity, but also enable a definitive assessment of whether or not the presence of this comorbid diagnosis is driving any observed significant between group differences.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
amygdala activation during Masked Affect Task
Time frame: measured once at fMRI session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
- Results publication: PubMed 21132846Rosso 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.
- Results publication: PubMed 21308886Killgore 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.
- Results publication: PubMed 19434621Britton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott L Rauch, MD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorder and Panic Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amygdala activation during Masked Affect Task (time frame: measured once at fMRI session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01849432, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2013; AzTrials last refreshed its copy on 6 Nov 2026.