Status:
COMPLETED
Evaluation of Substance P Neurotransmission in Panic Disorder by PET Imaging of NK1 Receptors With [18F]SPA-RQ
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Panic Disorder
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 understan...
Detailed Description
The involvement of Substance P (SP) in depression and anxiety has been credibly demonstrated in a recent clinical trial. Although the precise physiological activation mechanism of the SP system is not...
Eligibility Criteria
Inclusion
- 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.)
Exclusion
Key Trial Info
Start Date :
July 27 2004
Trial Type :
INTERVENTIONAL
End Date :
September 10 2008
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00088738
Start Date
July 27 2004
End Date
September 10 2008
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892