Panic DisorderPhase 1NCT00088738
Evaluation of Substance P Neurotransmission in Panic Disorder by PET Imaging of NK1 Receptors With [18F]SPA-RQ
A Phase 1 study testing [18F] SPA-RQ in people with Panic Disorder and Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Panic Disorder, Healthy
- What is being tested?
- [18F] SPA-RQ
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2004to 10 Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Adults ages 18-50
- Ages 18-50
- Male or Female
- Informed consent given
- Subjects who regularly consume caffeinated beverages.
- For Patients:
Show all 23Show fewer
- 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.
- 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.
Who cannot join
- 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.
Show all 47Show fewer
- Positive HIV test
- 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
- 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.)
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of Substance P Neurotransmission in Panic Disorder by PET Imaging of NK1 Receptors With [18F] SPA-RQ
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....
Read the 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 yet known, the likelihood of exaggerated SP pathway activity in the pathogenesis of anxiety is supported in numerous animal studies that illustrate the anxiogenic, and anxiolytic effects of SP and SP antagonists (SPAs), respectively. Studies have further shown that SP release occurs in response to noxious, or aversive stimulation. SP stimulates NK1 receptors that then undergo endocytosis (i.e., internalization) resulting in a decrease in number of NK1 receptors on the cell surface. NK1 receptor quantification before, and after an aversive event, provides a dynamic measurement of SP neurotransmission.
In this protocol, we will use a new PET ligand that has demonstrated ability to serve as an NK1 receptor antagonist, [18F]SPA-RQ ( [18F]-labeled Substance P Antagonist Receptor Quantifier). Using this tracer, we will: 1.) quantify NK1 binding parameters and determine the reliability and reproducibility of these measures in 10 healthy controls, 2.) we will look for regional differences in NK1 receptor binding in 10 patients with panic disorder (PD) versus 10 normal controls, and 3.) We will perform a single-blind, placebo-controlled study to evaluate NK1 receptor binding in PD patients and controls following either saline or doxapram infusion, which is a respiratory stimulant, in 20 patients with panic disorder (PD) versus 20 normal controls. Doxapram acts on both peripheral and medullary chemoreceptors to increase the rate and depth of breathing. It appears to be a potent and specific panicogenic agent, triggering panic attacks. The majority of PD patients, but not controls, are expected to experience a panic attack (aversive event) following the doxapram infusion. Comparison of pre-panic and post-panic NK1 receptor binding in PD patients will provide an estimate of SP release. The goal of the present study is to demonstrate the involvement of SP in panic disorder, and thereby, further our understanding of its role in the psychopathology of this illness.
- Conditions
- Panic Disorder, Healthy
- Being tested
- [18F] SPA-RQ
- Keywords
- Tachykinin, Anxiety, Neuroreceptor, Internalization, Carbon Dioxide, Healthy Volunteer, HV, Panic Disorder
- Medical subject headings
- Panic Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F] SPA-RQDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2004 (estimated)
- Study start27 Jul 2004
- Study completion10 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 84 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088738
- Sponsor's protocol ID
- 040189
- Other IDs
- 04-M-0189
- Status last verified
- 10 Sep 2008
- First submitted
- 30 Jul 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Kramer MS, Cutler N, Feighner J, Shrivastava R, Carman J, Sramek JJ, Reines SA, Liu G, Snavely D, Wyatt-Knowles E, Hale JJ, Mills SG, MacCoss M, Swain CJ, Harrison T, Hill RG, Hefti F, Scolnick EM, Cascieri MA, Chicchi GG, Sadowski S, Williams AR, Hewson L, Smith D, Carlson EJ, Hargreaves RJ, Rupniak NM. Distinct mechanism for antidepressant activity by blockade of central substance P receptors. Science. 1998 Sep 11;281(5383):1640-5. doi: 10.1126/science.281.5383.1640.
PubMed 9733503Stockmeier CA, Shi X, Konick L, Overholser JC, Jurjus G, Meltzer HY, Friedman L, Blier P, Rajkowska G. Neurokinin-1 receptors are decreased in major depressive disorder. Neuroreport. 2002 Jul 2;13(9):1223-7. doi: 10.1097/00001756-200207020-00031.
PubMed 12151774Deguchi K, Antalffy BA, Twohill LJ, Chakraborty S, Glaze DG, Armstrong DD. Substance P immunoreactivity in Rett syndrome. Pediatr Neurol. 2000 Apr;22(4):259-66. doi: 10.1016/s0887-8994(00)00120-x.
PubMed 10788742
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Substance P Neurotransmission in Panic Disorder by PET Imaging of NK1 Receptors With [18F] SPA-RQ
- ClinicalTrials.gov ID
- NCT00088738
- Acronym / sponsor ID
- 040189
- Conditions
- Panic Disorder, Healthy
- Keywords
- Tachykinin, Anxiety, Neuroreceptor, Internalization, Carbon Dioxide, Healthy Volunteer, HV, Panic Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 27 Jul 2004
- Study completion
- 10 Sep 2008
- First posted
- 2 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
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 yet known, the likelihood of exaggerated SP pathway activity in the pathogenesis of anxiety is supported in numerous animal studies that illustrate the anxiogenic, and anxiolytic effects of SP and SP antagonists (SPAs), respectively. Studies have further shown that SP release occurs in response to noxious, or aversive stimulation. SP stimulates NK1 receptors that then undergo endocytosis (i.e., internalization) resulting in a decrease in number of NK1 receptors on the cell surface. NK1 receptor quantification before, and after an aversive event, provides a dynamic measurement of SP neurotransmission.
In this protocol, we will use a new PET ligand that has demonstrated ability to serve as an NK1 receptor antagonist, [18F]SPA-RQ ( [18F]-labeled Substance P Antagonist Receptor Quantifier). Using this tracer, we will: 1.) quantify NK1 binding parameters and determine the reliability and reproducibility of these measures in 10 healthy controls, 2.) we will look for regional differences in NK1 receptor binding in 10 patients with panic disorder (PD) versus 10 normal controls, and 3.) We will perform a single-blind, placebo-controlled study to evaluate NK1 receptor binding in PD patients and controls following either saline or doxapram infusion, which is a respiratory stimulant, in 20 patients with panic disorder (PD) versus 20 normal controls. Doxapram acts on both peripheral and medullary chemoreceptors to increase the rate and depth of breathing. It appears to be a potent and specific panicogenic agent, triggering panic attacks. The majority of PD patients, but not controls, are expected to experience a panic attack (aversive event) following the doxapram infusion. Comparison of pre-panic and post-panic NK1 receptor binding in PD patients will provide an estimate of SP release. The goal of the present study is to demonstrate the involvement of SP in panic disorder, and thereby, further our understanding of its role in the psychopathology of this illness.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Healthy Adults ages 18-50
- Ages 18-50
- Male or Female
- Informed consent given
- Subjects who regularly consume caffeinated beverages.
Key exclusion criteria (47 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F] SPA-RQ | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 9733503Kramer MS, Cutler N, Feighner J, Shrivastava R, Carman J, Sramek JJ, Reines SA, Liu G, Snavely D, Wyatt-Knowles E, Hale JJ, Mills SG, MacCoss M, Swain CJ, Harrison T, Hill RG, Hefti F, Scolnick EM, Cascieri MA, Chicchi GG, Sadowski S, Williams AR, Hewson L, Smith D, Carlson EJ, Hargreaves RJ, Rupniak NM. Distinct mechanism for antidepressant activity by blockade of central substance P receptors. Science. 1998 Sep 11;281(5383):1640-5. doi: 10.1126/science.281.5383.1640.
- Background: PubMed 12151774Stockmeier CA, Shi X, Konick L, Overholser JC, Jurjus G, Meltzer HY, Friedman L, Blier P, Rajkowska G. Neurokinin-1 receptors are decreased in major depressive disorder. Neuroreport. 2002 Jul 2;13(9):1223-7. doi: 10.1097/00001756-200207020-00031.
- Background: PubMed 10788742Deguchi K, Antalffy BA, Twohill LJ, Chakraborty S, Glaze DG, Armstrong DD. Substance P immunoreactivity in Rett syndrome. Pediatr Neurol. 2000 Apr;22(4):259-66. doi: 10.1016/s0887-8994(00)00120-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F] SPA-RQ in people with Panic Disorder and Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00088738, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.