Serotonin Transporter Availability and Mood State in Normal Volunteers Taking Hypericum Perforatum (St. John's Wort)
Datos de Medicamento
Trastornos Mentales+1
+ Enfermedades del Sistema Nervioso Central
+ Enfermedades del sistema nervioso
Resumen
Fecha de inicio: 1 de septiembre de 1999
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 13 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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.
Centros del Estudio
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National Institute of Mental Health (NIMH)
Bethesda, United StatesAbrir National Institute of Mental Health (NIMH) en Google Maps