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NCT00001919 · ClinicalTrials.gov registry record
Neuroimaging of St. John's Wort-Induced Changes of Serotonin Metabolism in Normal Subjects
A clinical trial of Healthy and Mood Disorder, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 13
- Enrollment target
- 1
- Study location
NCT00001919: Completed study of Healthy and Mood Disorder, sponsored by National Institute of Mental Health (NIMH).
NCT00001919 is a study of Healthy and Mood Disorder that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 13 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001919, a study of Healthy and Mood Disorder, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
St. John's Wort is a popular dietary supplement that many people take to elevate mood or relieve stress. This study will test in normal volunteers whether this preparation may alter mood and if so, by what means. Animal studies suggest that St. John's Wort may work similarly to some antidepressants that affect levels of the chemical serotonin in the brain. Participants in this study must also be enrolled in NIMH protocol #98-M-0094 (SPECT Imaging of Dopamine and Serotonin Transporters in Neuropsychiatric Patients and Normal Volunteers) and protocol #91-M-014 (MRI Imaging of Neuropsychiatric Patients and Controls). Separate consent forms are required for each study. Candidates will undergo medical and psychiatric evaluations that may include blood and urine tests, electroencephalogram and electrocardiogram. Normal volunteers will have a mood assessment at the beginning of the study. They will then be randomly assigned to take either placebo (a pill with no active ingredient) or St. John's Wort 3 times a day for 2 weeks, and will be told what they are taking. After an 11-week hiatus, they will again start treatment on the same schedule, but will not be told which preparation they are receiving. Each evening during the 2-week treatment periods, subjects will complete a brief self-rating mood assessment questionnaire. At the end of each treatment period, they will undergo SPECT brain imaging (a type of CT scan) to determine dopamine and serotonin distribution and density in the brain. For this procedure, study subjects take three drops of potassium iodide solution within 24 hours before the scan and two drops nightly for 3 days following the procedure. About 10 ml (less than two teaspoons) of blood are drawn before a radioactive tracer is injected. SPECT imaging is done the next day. After about 1 hour of imaging, subjects are given either a placebo or St. John's Wort, and then imaging continues for another 2 hours. During the procedure, up to five blood samples of 6
Conditions Studied
Interventions
- DRUG Hypericum (LI-160)
Study Locations (1)
Maryland
- National Institute of Mental Health (NIMH) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 1999-09 |
| Est. Completion | 2002-06 |
What the finished NCT00001919 record still lists
NCT00001919 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Hypericum (LI-160) is the first listed.
NCT00001919 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001919 about?
NCT00001919 is a clinical study titled "Neuroimaging of St. John's Wort-Induced Changes of Serotonin Metabolism in Normal Subjects". St. John's Wort is a popular dietary supplement that many people take to elevate mood or relieve stress. This study will test in normal volunteers whether this preparation may alter mood and if so, by what means. Animal studies suggest that St. John's Wort may work similarly to some antidepressants ...
What is the current status of trial NCT00001919?
This trial is currently completed. The enrollment target is 13 participants. The study started on 1999-09. Estimated completion is 2002-06.
What conditions does trial NCT00001919 study?
This clinical trial studies the following conditions: Healthy, Mood Disorder.
What interventions are being tested in trial NCT00001919?
The interventions under investigation include: Hypericum (LI-160) (DRUG).
Who is sponsoring clinical trial NCT00001919?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001919 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00001919's enrollment target sits among peer trials
13 986th of 1090 higher than 96 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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