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NCT00263523 · ClinicalTrials.gov registry record · Phase 1
PET Imaging of Brain 5-HT(1A) Receptors Using [(11)C](-)-RWAY
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00263523 is a Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 15 participants.
The verdict
NCT00263523, a Phase 1 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI) to measure a serotonin receptor subtype in the brain called 5-HT(1A). This receptor is a target for drug therapy to treat anxiety and depression. The study will see if a newly developed radioligand (radioactive substance used in PET scanning to study the receptor systems of the brain) called \[(11)C\](-)-RWAY is more effective than other radioligands currently used in brain receptor research. Healthy subjects 18-40 years of age may be eligible for this study. Candidates are screened with a physical examination, electrocardiogram, and blood and urine tests. Participants undergo PET and MRI scanning as follows: PET scan PET uses small amounts of a radioactive chemical called a tracer (in this case, \[(11)C\](-)-RWAY) that "labels" active areas of the brain. For the procedure, the subject lies on the scanner bed. A special mask is fitted to the subject's head and attached to the bed to help keep the head still during the scan so the images will be clear. A brief scan is done just before the tracer is injected to provide measures of the brain that will help in the precise calculation of information from subsequent scans. Then, the tracer is injected through a catheter (plastic tube) placed in the arm and pictures are taken for about 2 hours, while the subject lies still on the scanner bed. Subjects return to the clinic for blood and urine tests 24 hours after the scan. MRI The MRI scan is done within 1 year of the PET scan. MRI uses a magnetic field and radio waves to produce images of body tissues and organs-in this case, the brain. The subject lies on a table that is moved into the scanner (a tube-like device), wearing earplugs to muffle the noise of the machine during the scanning process. The space in the scanner is confining and may cause some people to be somewhat anxious. An intercom system allows the subject to speak with the staff member performing the study at all
Interventions
- DRUG [11C] (-)-RWAY
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2005-12-05 |
| Est. Completion | 2007-08-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00263523
The ClinicalTrials.gov registry entry for NCT00263523 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [11C] (-)-RWAY is the first listed.
NCT00263523 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00263523 about?
NCT00263523 is a clinical study titled "PET Imaging of Brain 5-HT(1A) Receptors Using [(11)C](-)-RWAY". This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI) to measure a serotonin receptor subtype in the brain called 5-HT(1A). This receptor is a target for drug therapy to treat anxiety and depression. The study will see if a newly developed radioligand (radioacti...
What is the current status of trial NCT00263523?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2005-12-05. Estimated completion is 2007-08-15.
What interventions are being tested in trial NCT00263523?
The interventions under investigation include: [11C] (-)-RWAY (DRUG).
Who is sponsoring clinical trial NCT00263523?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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