Serotonin Transporter Availability and Mood State in Normal Volunteers Taking Hypericum Perforatum (St. John's Wort)
Drug Data
Behavior+5
+ Mental Disorders
+ Behavioral Symptoms
Summary
Study start date: September 1, 1999
Actual date on which the first participant was enrolled.Extracts of hypericum perforatum (St. John's 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 drug/placebo 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.13 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Free of concomitant medications and must be willing to take hypericum for a period of two weeks and a placebo for two weeks. No subjects with a relevant Axis I or Axis II disorder. No subjects with concomitant medical or neurological disorders which require ongoing medication, or which may affect the central nervous system; or taking medication with which St. John's wort may interact. Must not be pregnant. Must not be breastfeeding. No subjects with a prior reaction to iodine, iodine compounds, or shellfish. No subjects with a history of thyroid disease or dysfunction. No subjects with a history of recent substance abuse. No subjects with metal objects in their bodies. No subjects with a prior adverse reaction to hypericum extracts. No women who taking birth control pills.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Mental Health (NIMH)
Bethesda, United StatesOpen National Institute of Mental Health (NIMH) in Google Maps