Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001919
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Neuroimaging of St Johns Wort-Induced Changes of Serotonin Metabolism in Normal Subjects
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Serotonin Transporter Availability and Mood State in Normal Volunteers Taking Hypericum Perforatum St Johns Wort
Status:
COMPLETED
Status Verified Date:
2002-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
St Johns 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 Johns 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 Johns 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 Johns Wort and then imaging continues for another 2 hours During the procedure up to five blood samples of 6 ml each may be drawn At some point during the study a MRI scan of the brain will be done
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 Johns 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 Johns Wort and then imaging continues for another 2 hours During the procedure up to five blood samples of 6 ml each may be drawn At some point during the study a MRI scan of the brain will be done
Detailed Description:
Extracts of hypericum perforatum St Johns wort have become increasingly popular for the treatment of mood disorders Hypericum extracts have been approved in Germany for the treatment of mild to moderate depression and are now available in standardized preparations In the United States hypericum extracts are frequently purchased as over the counter preparations Inhibition of the serotonin transporter similar to clinically used selective serotonin reuptake inhibitors SSRIs has been suggested as a possible mechanism of action for the antidepressant properties of hypericum extracts We propose to study the effects of hypericum extracts on mood states in normal volunteers who are concurrently volunteering under NIMH protocol 98-M-0094 for SPECT imaging of serotonin and dopamine transporter availability with I-123 Beta-CIT A placebo-controlled double-blind within-subject design will be employed with two two-week periods of drugplacebo administration clinical assessment and SPECT imaging separated by eleven weeks We plan to test three hypotheses 1 that hypericum alters mood state 2 that hypericum reduces serotonin transporter availability and 3 that these actions are quantitatively associated with one another
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-M-0151 | None | None | None |