Serotonin Transporter Availability and Mood State in Normal Volunteers Taking Hypericum Perforatum (St. John's Wort)
Médicament Data
Troubles Mentaux+2
+ Maladies du système nerveux central
+ Maladies du système nerveux
Résumé
Date de début de l'étude : 1 septembre 1999
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.13 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Centres d'étude
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National Institute of Mental Health (NIMH)
Bethesda, United StatesOuvrir National Institute of Mental Health (NIMH) dans Google Maps