Evaluation of Substance P Neurotransmission in Panic Disorder by PET Imaging of NK1 Receptors With [18F]SPA-RQ

• Status: Completed
• Trial end date: 2008-09-10
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to observe the effects of a panic attack in patients with panic disorders and to demonstrate the involvement of Substance P in panic disorder, and thereby, further our understanding of its role in this illness. We will measure levels of Substance P in the brain by obtaining pictures of the brain using PET and MRI....

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Mental Health (NIMH)
• Treatments: (2-fluoromethoxy-5-(5-trifluoromethyltetrazol-1-yl)benzyl)(2-phenylpiperidin-3-yl)amine; Neurokinin A; Substance P

Criteria

• INCLUSION CRITERIA: (Phase 1) Whole Body Imaging

• Healthy Adults ages 18-50

EXCLUSION CRITERIA (Phase 1) Whole Body Imaging

• History of psychiatric disease, substance dependence or traumatic brain injury, severe systemic disease, poor vision or hearing

• History of substance abuse within 6 months

• Abnormal laboratory tests, including HIV test

• Any prior participation in other research protocols involving radiation exposure within the past year

• Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits. Limits: A total effective dose 2.5 rem in a year and 2.5 rad per year to the lens of the eyes, gonads and blood-forming organs; and 7.5 rad annually for all other organs.

• Pregnancy and Breast Feeding.

• Positive HIV test

INCLUSION CRITERIA: (Phase 2) Kinetic

• Ages 18-50

• Male or Female

• Informed consent given

• Subjects who regularly consume caffeinated beverages.

EXCLUSION CRITERIA: (Phase 2) Kinetic

• DSM-IV Axis I diagnostic criteria such as history of, or current Dx ADHD, mood/anxiety disorder, alcohol or psychoactive substance abuse/dependence

• Psychotropic medication or other drugs that may cross the blood brain barrier

• Traumatic brain injury, severe systemic disease

• Abnormal MRI other than minor atrophy

• Abnormal laboratory tests, including HIV test

• Claustrophobia

• Pregnancy or breast feeding

• Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits. Limits: A total effective dose or 5.0 rem in a year

• Any condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in the eye, etc.)

• Single radial and ulnar arterial circulation

• Individuals who recently donated blood

• Unable to lay on one's back for PET/MRI scans

• Novocaine allergy

• Positive HIV test

INCLUSION CRITERIA: (Phase 3A) Challenge

For Patients:

• Ages 18-65.

• DSM IV criteria for Panic Disorder

• Informed consent given.

• Subjects who regularly consume caffeinated beverages.

For Controls:

• Ages 18-65.

• Informed consent given.

• Subjects who regularly consume caffeinated beverages.

EXCLUSION CRITERIA: (Phase 3A) Challenge

For Patients and Controls:

• Current diagnosis of substance abuse or dependence

• History of substance dependence

• Psychotropic medication in last 3 weeks (8 weeks for fluoxetine/Prozac) except for benzodiazepene during PET or MRI scans

• Abnormal MRI other than minor atrophy

• Abnormal laboratory tests, including HIV test

• Pulmonary disease (e.g. COPD, asthma)

• Claustrophobia

• History of hypertension, coronary artery disease and subjects who are taking sympathomimetic medications

• Pregnancy or breastfeeding

• Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits. Limits: A total effective dose or 5.0 rem in a year

• Unable to lay on one's back for PET/MRI scans

• Any condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in the eye, etc.)

INCLUSION CRITERIA: (Phase 3B) Comparative

For Patients:

• Ages 18-65.

• DSM IV criteria for Panic Disorder

• Informed consent given.

• Subjects who regularly consume caffeinated beverages.

For Controls:

• Ages 18-65.

• Informed consent given.

• Subjects who regularly consume caffeinated beverages.

EXCLUSION CRITERIA: (Phase 3B) Comparative

For Patients and Controls:

• Current diagnosis of substance abuse or dependence

• History of substance dependence

• Psychotropic medication in last 3 weeks (8 weeks for fluoxetine/Prozac) except for benzodiazepene during PET or MRI scans

• Abnormal MRI other than minor atrophy

• Abnormal laboratory tests, including HIV test

• Pulmonary disease (e.g. COPD)

• Claustrophobia

• History of hypertension, coronary artery disease and subjects who are taking sympathomimetic medications

• Pregnancy or breastfeeding

• Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits. Limits: A total effective dose or 5.0 rem in a year

• Unable to lay on one's back for PET/MRI scans

• Any condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in the eye, etc.)