This study is NOT currently recruiting participants.
Number
02-M-0321
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
No
Population Exclusion(s)
Non-English Speaking;Children
Keywords
Stress; Fear; Anxiety; Neuroimaging; Unpredictability; Healthy Volunteer (HV)
Recruitment Keyword(s)
Healthy Volunteer; HV
Condition(s)
Anxiety Disorders; Fear
Investigational Drug(s)
None
Investigational Device(s)
Intervention(s)
Device: Shock device Device: Acoustic startle
Supporting Site
National Institute of Mental Health
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.
--Back to Top--
INCLUSION CRITERIA: 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 National Institute of Mental Health (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 Diagnostic and Statistical Manual (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) EXCLUSION CRITERIA: 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, monoamine oxidase (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-human chorionic gonadotropin (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) Reynaud's syndrome for the cold pressor test experiment 15) Color blindness (for the active avoidance task only) ADDITIONAL EXCLUSION CRITERIA FOR PATIENTS: 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 psychotropic 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.
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 National Institute of Mental Health (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 Diagnostic and Statistical Manual (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)
EXCLUSION CRITERIA:
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, monoamine oxidase (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-human chorionic gonadotropin (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) Reynaud's syndrome for the cold pressor test experiment
15) Color blindness (for the active avoidance task only)
ADDITIONAL EXCLUSION CRITERIA FOR PATIENTS:
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 psychotropic 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.
Principal Investigator
Referral Contact
For more information: