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Protocol Details

fMRI Investigation of Explicit Cue and Contextual Fear

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 50 Years

Referral Letter Required


Population Exclusion(s)

Non-English Speaking;



Recruitment Keyword(s)

Healthy Volunteer;


Anxiety Disorders;

Investigational Drug(s)


Investigational Device(s)



Device: Shock device
Device: Acoustic startle

Supporting Site

National Institute of Mental Health

The purpose of this study is to use brain imaging technology to investigate brain changes in people exposed to predictable versus unpredictable unpleasant stimuli. Unpleasant events that can be predicted evoke a response of fear, whereas unpredictable, unpleasant stimuli cause chronic anxiety not associated with a specific event. Information gained from this study may help in the development of more effective treatments for anxiety disorders.

When confronted with fearful events, people eventually develop fear of specific cues that were associated with these events as well as to the environmental context in which the fearful event occurred. Evidence suggests that cued fear and contextual fear model different aspects of anxiety. However, studies that examine the way the brain affects expression of contextual fear have not been conducted. This study will use magnetic resonance imaging (MRI) or Magneto-encephalography (MEG) to compare the brain activity underlying fear brought on by predictable and unpredictable aversive stimuli.

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All screening procedures described in this section are conducted under screening protocol 01-M-0254. Subjects must meet the following inclusion criteria in order to participate in the study:

1) Male or female volunteers ages 18-50 years old.

2) Judged to be in good physical health on the basis of medical history, a clinical MRI scan, and physical examination. Physical exams will be conducted by a NIMH credentialed physician or nurse. Clinical laboratory tests will be ordered based on his/her discretion.

3) Healthy subjects judged to be in good psychiatric health on the basis of the Structured Clinical Interview for DSM-IV-TR. The SCID will be administered by a credentialed NIMH clinician.

4) Able to understand procedures and agree to participate in the study by giving written informed consent.

5) This protocol (02-M-0321) will include patients with a primary diagnosis (under the clinical responsibility of Dr. Daniel Pine) of generalized anxiety disorder, panic disorder, SAD, PTSD, specific phobia, and major depression according to DSM-IV.

6) Subjects will not be asked to completely stop smoking or drinking coffee during this study because they may experience withdrawal symptoms, which could affect our study results. However, they will be asked to abstain from drinking caffeinated beverage including coffee, tea and caffeinated soft drinks and from smoking for at least 1 hour prior to testing. They will also be instructed not to drink alcohol on the night prior to testing and on the day of testing.

7) Speaks English or Spanish fluently (subjects with Major Depressive Disorder, healthy volunteers)

8) Speaks English fluently (subjects with Anxiety Disorder)


Subjects will be excluded from the study if they meet the following exclusion criteria:

1) Clinically significant organic disease, e.g., cardiovascular disease.

2) Clinically significant abnormalities in physical examination.

3) Any medical condition that increases risk for fMRI (e.g. pacemaker, metallic foreign body in eye).

4) History of any disease, which in the investigators opinion may confound the results of the study, including, but not limited to, history of organic mental disorders, seizure, or mental retardation.

5) Have a current diagnosis of alcohol or substance abuse ACCORDING TO DSM IV CRITERIA

6) Have a lifetime diagnosis of alcohol or substance dependence ACCORDING TO DSM IV CRITERIA.

7) Unless subject is enrolled as a patient, subjects should not have current Axis I psychiatric disorders as identified with the Structured Clinical Interview for DSM-IV, non-patient edition (SCID/NP).

8) If a healthy volunteer, past bipolar depression and any history of psychosis or delusional disorders.

9) If a healthy volunteer, first degree relative with history of psychotic disorder such as schizophrenia or bipolar disorder

10) If a healthy volunteer, psychotropic medication within 4 weeks of scanning

11) Medications that act on the central nervous system (e.g., Lorazepam, Codeine) and thus may interfere with the interpretation of study results. Specific exclusionary drug classes include but are not limited to: (opioid analgesics, DA receptor agonists, anticholinergics, MAO inhibitors, COMT inhibitors, as well as any illicit substances). In addition, healthy participants may not be on psychotropic medications.

12) Pregnancy, i.e., a positive Beta-HCG urine test conducted prior to each experiment session.

13) Current or past history of cubital tunnel syndrome or carpal tunnel syndrome for shock studies that use the wrist for placement of electrodes. Cubital tunnel and carpal tunnel syndrome are exclusionary only for diagnosis on same arm as electrodes and are not exclusionary for studies that place shocks on ankles or feet.

14) Reynauds syndrome for the cold pressor test experiment

15) Color blindness (for the active avoidance task only)


Patients who would be unable to comply with study procedures or assessments.

Patients will be excluded if they have a current or past history of any psychotic disorder, bipolar disorder, delirium, dementia, amnestic disorder, cognitive disorder not otherwise specified, any of the pervasive developmental disorders, or mental retardation

Patients (except PTSD) on psychotrophic medications within 2 wees of study visits, or within 6 weeks of study visits for fluoxetine will be excluded.

PTSD patients on psychotropics medication within 2 weeks of study visits will be excluded, with the exception of antidepressants, and benzodiazepines; the preceding two classes of medications will not preclude enrollment for PTSD participants only.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Maryland Pao, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CRC BG RM 6-5332
(301) 435-5770

Maryland Pao, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CRC BG RM 6-5332
(301) 435-5770

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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