PET Whole Body Distribution Studies Using [11C]CUMI
30 de junio de 2017 actualizado por: National Institute of Mental Health (NIMH)
PET Whole Body Distribution Studies Using the 5-HT1A Agonist, [11C]CUMI
Background:
- Researchers studying new treatments for major depressive disorder are looking at how medications to treat depression act on the brain chemical serotonin, which interacts with specific serotonin receptors on brain cells. New methods of studying serotonin receptors in the brain may help provide a better understanding of depression and treatment options.
- A new radioactive chemical called [11C]CUMI may be useful for studying serotonin receptors in the brain. By using positron emission tomography (PET) scanning to see how [11C]CUMI bonds with serotonin receptors, researchers will investigate whether [11C]CUMI can be used to study depression and how antidepressant medications work.
Objectives:
- To determine the usefulness of [11C]CUMI as a method of studying serotonin receptors in the brain.
Eligibility:
- Healthy individuals between 18 and 65 who have no history of psychiatric illness.
Design:
- This study requires 8 outpatient visits to the NIH clinic.
- Visit 1: Participants will have a full physical examination and medical history, as well as a psychiatric evaluation and questions about alcohol and drug use. Other tests will include blood and urine samples and an electrocardiogram (EKG). Testing will take approximately 3 hours.
- Visit 2: Participants will have a magnetic resonance imaging (MRI) scan to evaluate brain function and activity.
- Visit 3: Participants will have a PET scan, in which a small amount of the radioactive chemical [11C]CUMI will be injected through an intravenous (IV) catheter, and will have another IV line put in place to draw regular blood samples during the scan. The scan will last approximately 4 hours.
- Visits 4-8: Participants will have regular blood tests after the scan between days 1-3 and at about weeks 1, 2, 3, and 4. The blood tests will check muscle, heart, and liver function.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Descripción detallada
Eighteen million people in the United States are currently suffering from Major Depressive Disorder, which is characterized by episodes of low mood, poor self attitude and poor vitality. Of those suffering from Major Depressive Disorder (MDD), only one third completely improve, but even among these cases, there is a waiting period of several weeks or more during which antidepressants take effect. Our inability to adequately treat MDD is evident in its being ranked number one in Disability Adjusted Life Years (DALY) among persons aged 15-44. Given this profound burden, improving our understanding of the molecular basis of MDD is of utmost importance in the development of novel antidepressant medications.
Serotoninergic neurotransmission is implicated in MDD, as demonstrated by the relative success of selective serotonin reuptake inhibitors (SSRIs). SSRIs block the reuptake of serotonin through the serotonin transporter, which then increases serotonin at the synaptic cleft. Serotonin then binds to 5-HT(1A) receptors, which are G-protein coupled receptors that are present both presynaptically and postsynaptically. Presynaptically, these receptors act as autoinhibitory receptors, triggering decreased firing rates and decreased serotonin release. This autoinhibitory mechanism is believed to be the reason why patients experience a delay in symptomatic improvement after initiation of SSRIs. Serotonin binding to postsynaptic receptors mediates symptomatic improvement of depression. Multiple positron emission tomography (PET) studies on 5-HT(1A) have been published. However, none of these studies use 5-HT(1A) agonists, which are specific for the high affinity, G-protein coupled and active state of the 5-HT(1A) receptor. We would therefore like to establish the use of the 5-HT(1A) radiolabelled agonist, [(11)C]CUMI, here at NIH.
The purpose of this study is to perform whole body PET studies in healthy volunteers in order to estimate radiation absorbed doses for [(11)C]CUMI. Future experiments will include studies on Major Depressive Disorder.
Tipo de estudio
Tipo de estudio
De observación
Inscripción (Actual)
Inscripción
12
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
INCLUSION CRITERIA:
- Subjects must be adults between 18-65 years old.
- Subjects must be able and willing to give written informed consent.
EXCLUSION CRITERIA:
- With the exception of substance abuse disorders, any past or current Axis I diagnosis as assessed by clinical interview which may include the SCID-NP. With regard to substance abuse, we will allow a history of substance abuse so long as criteria for substance dependence are not met, and the episode(s) of substance abuse occurred over 1 year prior to study enrollment.
- Any prior use of Lysergic acid diethylamide (LSD).
- Use of ecstasy more than 3 times in a lifetime.
- Any history of psychotic symptoms.
- If female, any history of Premenstrual Dysphoric Disorder (PMDD), because PMDD has been shown to correlate with changes in 5-HT1A distribution in brain.
- In women, irregular menses such that the subject will not know the phase of the menstrual cycle at time of scanning.
- Clinically significant laboratory abnormalities.
- Psychotropic medication use (including benzodiazepines and illicit drugs) during the 28 days (42 day for fluoxetine) prior to the PET scan.
- Serious medical problems including but not limited to chronic neurological disease such as multiple sclerosis, autoimmune diseases or any cardiopulmonary disease that would increase risks associated with sedation.
- Positive HIV status.
- Head trauma resulting in a period of unconsciousness lasting longer than 10 minutes.
- History of fetal alcohol syndrome or other neurodevelopmental disorder.
- Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
- Positive urine drug screen.
- Inability to lie flat on camera bed for about 2.5 hours.
- Pregnancy at time of scan (beta HCG will be measured in all female patients within 24 hours of scan and must be negative).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Marta Gozzi, Ph.D., National Institute of Mental Health (NIMH)
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Alpert JE, Franznick DA, Hollander SB, Fava M. Gepirone extended-release treatment of anxious depression: evidence from a retrospective subgroup analysis in patients with major depressive disorder. J Clin Psychiatry. 2004 Aug;65(8):1069-75.
- Amsterdam JD, Brunswick DJ, Gibertini M. Sustained efficacy of gepirone-IR in major depressive disorder: a double-blind placebo substitution trial. J Psychiatr Res. 2004 May-Jun;38(3):259-65. doi: 10.1016/j.jpsychires.2003.10.005.
- Amsterdam JD. Gepirone, a selective serotonin (5HT1A) partial agonist in the treatment of major depression. Prog Neuropsychopharmacol Biol Psychiatry. 1992 May;16(3):271-80. doi: 10.1016/0278-5846(92)90079-t.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
30 de abril de 2010
Finalización del estudio
Finalización del estudio
12 de abril de 2012
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
27 de mayo de 2010
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
27 de mayo de 2010
Publicado por primera vez (Estimar)
Publicado por primera vez
28 de mayo de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
2 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
30 de junio de 2017
Última verificación
Última verificación
12 de abril de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 100110
- 10-M-0110
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