Functional Brain Imaging in PTSD

NCT ID: NCT02053532

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-02-29

Brief Summary

Patients with post-traumatic stress disorder (PTSD) have abnormalities in the function of the amygdala and medial prefrontal cortex (particularly anterior cingulate), in addition to abnormalities of hippocampal volume. In this pilot study we propose to use the combined positron emission tomography/magnetic resonance (PET/MR) scanner and F-18-fluorodeoxyglucose (FDG, an analog of glucose, the most commonly used PET ligand) to examine brain function and directly correlate the data with the intrinsic functional connectivity of brain circuits that are responsible for social, emotional and cognitive processing in both individuals with PTSD and group-matched trauma controls (TC) and healthy controls (HC). Once the machine is validated, we will then use a more specific biomarker to better understand the neurochemical factors that contribute to individual differences in PTSD. Thus, the data obtained from this pilot study will guide our future molecular imaging studies. The link between general brain function, specific molecular target and the intrinsic functional connectivity of brain circuits that are responsible for social, emotional and cognitive processing in PTSD, TC and HC will be explored.

Conditions

Post-traumatic Stress Disorder (PTSD); Trauma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Positron emission tomography/magnetic resonance imaging

Positron emission tomography/magnetic resonance imaging

Intervention Type: PROCEDURE

Positron emission tomography/magnetic resonance (PET/MR) imaging using 18-F-fluorodeoxyglucose (FDG) as radio tracer

Interventions

Positron emission tomography/magnetic resonance imaging

Positron emission tomography/magnetic resonance (PET/MR) imaging using 18-F-fluorodeoxyglucose (FDG) as radio tracer

Intervention Type: PROCEDURE

Other Intervention Names

PET Imaging

Eligibility Criteria

Inclusion Criteria

1. Age 18-55 years old

2. Currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score > 50

1. Age 18-55 years old

2. No personal or first-degree family history of any Axis I diagnosis

1. . Age 18-55 years old;

2. . No personal or first-degree family history of any Axis I diagnosis;

3. . Has a lifetime history of trauma.

Exclusion Criteria

1. any primary Axis I disorder other than PTSD (e.g. psychosis)

2. medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders

3. a history of drug (including benzodiazepines (BZD)) dependence (Diagnostic and Statistical Manual (DSM) IV criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence

4. current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study)

5. current breast feeding

6. nicotine dependence

7. suicidal ideation or behavior

9. Human immunodeficiency virus (HIV) (due to possible neuropsychiatric effects)

10. Hepatitis B or C (due to possible neuropsychiatric effects)

11. use of opioid medications within 2 weeks of the positron emission tomography (PET) study

12. having an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participation in the study

13. seriously claustrophobic

14. blood donation within 8 weeks prior to the study

15. positive alcohol breathalyzer test

16. Abnormal thyroid test indicated by thyroid stimulating hormone (TSH) < .15 mlU/L and/or thyroxine (T4) > 18 mcg/dL

17. Glucose > 200 mg/dL on two separate days

For Healthy Subjects

1. . any history or current primary Axis I disorder ;

2. . medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders;

3. . a history of drug (including benzodiazepines [BZD]) dependence (DSM IV criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence;

4. . current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study);

5. . current breast feeding;

6. . nicotine dependence;

7. . suicidal ideation or behavior;

9. . HIV (due to possible neuropsychiatric effects);

10. . Hepatitis B or C (due to possible neuropsychiatric effects);

11. . use of opioid medications within 2 weeks of the PET study;

12. . having an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participation in the study;

13. . seriously claustrophobic;

14. . blood donation within 8 weeks prior to the study;

15. . positive alcohol breathalyzer test;

16. . Abnormal thyroid test indicated by TSH < .15 mlU/L and/or T4 > 18 mcg/dL;

17. . Glucose > 200 mg/dL on two separate days;

18. . Does not have a lifetime history of trauma.

For Healthy Subjects with Trauma ("Trauma Controls")

1. . any history or current primary Axis I disorder ;

2. . medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders;

3. . a history of drug (including benzodiazepines [BZD]) dependence (DSM IV criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence;

4. . current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study);

5. . current breast feeding;

6. . nicotine dependence;

7. . suicidal ideation or behavior;

9. . HIV (due to possible neuropsychiatric effects);

10. . Hepatitis B or C (due to possible neuropsychiatric effects);

11. . use of opioid medications within 2 weeks of the PET study;

12. . having an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participation in the study;

13. . seriously claustrophobic;

14. . blood donation within 8 weeks prior to the study;

15. . positive alcohol breathalyzer test;

16. . Abnormal thyroid test indicated by TSH < .15 mlU/L and/or T4 > 18 mcg/dL;

17. . Glucose > 200 mg/dL on two separate days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NYU School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

S13-00313

Identifier Type: -

Identifier Source: org_study_id