Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02237703
Other study ID # S12-01521
Secondary ID
Status Terminated
Phase N/A
First received September 9, 2014
Last updated January 19, 2017
Start date March 2012
Est. completion date August 2016

Study information

Verified date January 2017
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study uses positron emission tomography (PET) imaging to measure kappa opioid receptors (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD). The investigators propose to recruit 45 drug-naïve individuals, N=15 patients with PTSD, N=15 trauma-exposed, but asymptomatic healthy control subjects (TC) and N=15 non-trauma exposed healthy control subjects (HC) to participate in one magnetic resonance imaging (MRI) and one PET study. The investigators will also carefully document trauma history, and collect behavioral and neuroendocrine measures to provide a more integrative view on the neurobiology of PTSD and its phenotype. The investigators predict PTSD will show greater carbon - 11 (11C)[11C]LY2795050 volume of distribution (VT) (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.


Recruitment information / eligibility

Status Terminated
Enrollment 17
Est. completion date August 2016
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion criteria for patients with PTSD:

1. age 18-55 years old

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

Exclusion criteria for patients with PTSD:

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 of Mental Disorders (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. use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day, or cannot abstain from smoking during the prescribed tests

7. acute suicidal ideation or behavior, as defined by suicidal ideation and behavior during the 3-month period prior to enrollment in the study and while being enrolled in the study

8. general MRI exclusion criteria, i.e. pacemakers, metals in the body

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

10. use of opioid medications within 2 weeks of the PET study

11. 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

12. seriously claustrophobic

13. blood donation within 8 weeks prior to the study.

Inclusion criteria for Healthy Subjects:

1. age 18-55 years old

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

Exclusion criteria 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. use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day, or cannot abstain from smoking during the prescribed tests

7. acute suicidal ideation or behavior, as defined by suicidal ideation and behavior during the 3-month period prior to enrollment in the study and while being enrolled in the study

8. general MRI exclusion criteria, i.e. pacemakers, metals in the body

9. HIV (due to possible neuropsychiatric effects)

10. use of opioid medications within 2 weeks of the PET study

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

12. seriously claustrophobic

13. blood donation within 8 weeks prior to the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Positron emission tomography (PET) imaging
Positron emission tomography (PET) imaging

Locations

Country Name City State
United States NYU School of Medicine New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York University School of Medicine Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Volume of distribution (VT) of cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET To examine group differences in cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET.
Hypothesis: PTSD will show greater [11C]LY2795050 VT (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.
Two months
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Terminated NCT03781817 - Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures Phase 4
Completed NCT04342416 - Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women N/A
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Recruiting NCT04725721 - Testing FIRST in Youth Outpatient Psychotherapy N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT03696563 - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS N/A
Withdrawn NCT03249129 - Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Completed NCT02240732 - Surgical Tourniquets and Cerebral Emboli N/A
Completed NCT02227979 - Effects of PURPLE Cry Intervention N/A
Withdrawn NCT01169025 - Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT03112304 - Child STEPS for Youth Mental Health in Maine Sustainability N/A
Completed NCT01475344 - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC) Phase 1/Phase 2
Completed NCT01201863 - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy Phase 4
Completed NCT01210417 - Trauma Heart to Arm Time N/A