Serotonin Receptors in Seizure Disorders
Launched by NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) · Nov 3, 1999
Trial Information
Current as of March 20, 2025
Completed
Keywords
ClinConnect Summary
Objective: to study serotonin receptors in patients with localization-related epilepsy. Studies in experimental animals have suggested that: Serotonin is an anticonvulsant neurotransmitter in a number of seizure models; its anticonvulsant action is mediated by activation of 5-HT(1A) receptors; drugs with antiepileptic effects may release 5HT or block reuptake, and these mechanisms appear to be related to their therapeutic effect. 5HT(1A) receptors are abundant in regions such as entorhinal cortex, hippocampus, and temporal neocortex, where epileptogenic zones are frequently found. Considera...
Gender
ALL
Eligibility criteria
- * INCLUSION CRITERIA:
- • Patients must have clinically documented partial seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, refractory to standard antiepileptic treatment for at least one year.
- • Patients will be in age ranges of 18 to 60.
- • Patients may be male or female. Female patients of child bearing potential will have a pregnancy test prior to each PET scan to ensure that pregnant patients will not participate in the study. During the study, woman of child bearing potential must use a reliable method of birth control.
- Three groups of patients will be scanned:
- • 50 patients with EEG and clinical evidence for mesial temporal onset with either MRI findings of mesial temporal sclerosis (MTS) or dysplasia or normal MRI studies.
- • 25 patients with apparent neocortical seizure foci.
- • In addition, patients will be screened for the presence of depression in addition to epilepsy; at least 15 patients from groups 1 and 2 who currently meet DSM-IV criteria for the category "Mood disorder due to epilepsy" (293.83), and the subtype "with major Depressive-Like Episode" 296.2 Major Depressive Disorder, Single Episode, or 296.3 Major Depressive Disorder, Recurrent, indicating that subjects meet diagnostic criteria for a major depressive episode. DSM diagnoses will be based on the Research Version of the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I) including the detailed assessment of the course of both epilepsy and depressive symptoms as well as the family history of medical and psychiatric conditions.
- • Twenty healthy normal adults will be included. Controls will be screened in the NINDS Clinical Epilepsy Section outpatient clinic, with physical examination, CBC urinalysis and blood chemistries. Controls with chronic illnesses, taking any medications, or who smoke will be excluded. They will be asked to abstain from alcohol for one week before the study.
- EXCLUSION CRITERIA:
- • Patients younger than 18 or older than 60 years old will be excluded from the study.
- • Patients with a known treatable seizure etiology such as neoplastic or infectious disease will be excluded.
- • Patients with MRI findings consistent with brain tumors, trauma or AVMs will be excluded.
- • Patients with progressive neurologic disorders.
- • Patients with a history of significant medical disorders, or requiring chronic treatment with other drugs which can not be stopped, except for SSRIs.
- • Patients with cancer.
- • Patients not capable of giving an informed consent.
- • Patients who had seizure activity 24 hours prior to the study.
About National Institute Of Neurological Disorders And Stroke (Ninds)
The National Institute of Neurological Disorders and Stroke (NINDS) is a leading component of the National Institutes of Health (NIH), dedicated to advancing our understanding of the brain and nervous system through innovative research. NINDS sponsors and conducts clinical trials aimed at developing effective treatments and improving patient outcomes for a wide range of neurological disorders, including stroke, epilepsy, multiple sclerosis, and neurodegenerative diseases. By fostering collaboration among researchers, healthcare providers, and patient communities, NINDS plays a pivotal role in transforming scientific discoveries into clinical applications, ultimately enhancing the quality of life for individuals affected by neurological conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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