EpilepsyNCT00439387
The Role of Serotonin in Seizures
An observational study of Epilepsy and Seizures, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will investigate the role that a brain chemical called serotonin plays in seizures. Serotonin, present naturally in the brain, helps transmit signals between nerve cells. Glucose is a sugar that is the main fuel of the brain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2007to 5 Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have seizures documented by appropriate clinical and laboratory studies . This criterion will be established by studies performed by the referring physicians, preliminary screening in the NINDS Clinical Epilepsy Section outpatient clinic, or if necessary, inpatient video-EEG monitoring.
- Male and Female subjects aged between 18 and 60 years
- Healthy control subjects will also be recruited.
- Subjects must be able to give written informed consent prior to participation in this study.
Who cannot join
- Patients younger than 18 or older than 60 years old. There is evidence for reduced 5HT1A receptor binding in patients over 60.
- Patients with a known treatable seizure etiology such as neoplastic or infectious disease.
- Patients with MRI findings consistent with brain tumors, trauma or AVMs.
- Patients with progressive neurologic disorders.
- Patients with a history of significant medical disorders, or requiring treatment with drugs
- that can not be stopped, and would interfere with the study, except for antidepressants.
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- Patients with cancer.
- Patients not capable of giving an informed consent.
- Patients who had seizure activity 24 hours prior to the study.
- Women who are pregnant or nursing
- Subjects who are current smokers, and cannot stop for at least two weeks before the PET scan, as smoking may affect serotonergic neurotransmission.
- Healthy subjects must be free from a personal history of seizure disorders
- Patients with coagulation abnormalities.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Imaging Serotoninergic Neurotransmission in Epilepsy
This study will investigate the role that a brain chemical called serotonin plays in seizures. Serotonin, present naturally in the brain, helps transmit signals between nerve cells. Glucose is a sugar that is the main fuel of the brain. Studying these two chemicals may help explain why people with epilepsy get seizures and are more likely to be depressed.
Healthy volunteers and patients 18 to 60 years of age who have epilepsy with or without depression and whose seizures are not controlled by medication may be eligible for this study. Candidates are screened with a review of their medical history, a physical examination and an electroencephalogram (EEG, brain wave recording).
Read more
Participants undergo the following procedures:
- Positron emission tomography (PET) scans: The first of three PET scans measures brain blood flow and the activity at some of the brain serotonin receptors (the parts of brain cells to which serotonin attaches). A second scan measures the amount of serotonin transported between brain cells. A third scan measures glucose use. The PET scanner is shaped like a doughnut. The subject lies on a bed that slides in and out of the scanner with his or her head inside the opening. A special mask is fitted to the subject s head to help keep it still during the procedure so the images will be clear. For the first scan, catheters (plastic tubes) are placed in an arm vein to inject a radioactive substance and in an artery in the wrist to collect blood samples. The other two scans require only the catheter in the arm.
- Magnetic resonance imaging: This test uses a strong magnetic field and radio waves to obtain images of the brain. The scanner is a metal cylinder surrounded by a strong magnetic field. The subject lies on a table that can slide in and out of the cylinder. Most scans last between 45 and 90 minutes. Subjects wear earplugs to muffle loud knocking noises that occur during scanning.
- Psychological evaluation: Subjects are interviewed and fill out questionnaires to help study sadness and depression in epilepsy.
- Blood draw: Blood tests look for differences in genes between people with epilepsy who are depressed and those who are not.
Read the detailed description
Objective: To study serotonergic transmission in epilepsy and its relation to cerebral glucose metabolism, mesial temporal sclerosis, and depression.
Study population: Patients with localization-related epilepsy with and without depression, and generalized epilepsy, and normal controls, ages 18-60.
Design: This is a neuroimaging study using positron emission tomography with a 5HT(1A) receptor ligand, 18F-FCWAY, a serotonin transporter ligand, 11C-DASB, and 15O-H2O for cerebral blood flow estimation. Patients will have measurements of cerebral glucose metabolism using 18F-FDG as well. Magnetic resonance imaging will be performed for examination of hippocampal structure and partial volume correction. Screening for depression will be performed by NIMH investigators. We will measure cortisol and ACTH levels, which may affect hippocampal structure and function. Testing for genetic markers that may predict serotonin transporter activity and depression will be performed.
Outcome measures: 5HT(1A) receptor binding, serotonin transporter activity, cerebral blood flow, and, in patients, glucose metabolism and hippocampal structure. Patients will be stratified by seizure type and depression ratings.
- Keywords
- Serotonin, Epilepsy, Healthy Volunteer, HV
- Medical subject headings
- Epilepsy, Seizures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study start20 Feb 2007
- Study completion5 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- William H Theodore, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439387
- Sponsor's protocol ID
- 070103
- Other IDs
- 07-N-0103
- Status last verified
- 5 Jun 2015
- First submitted
- 22 Feb 2007
- Last updated
- 5 Jul 2018
- Results posted
- No
Publications
Bromfield EB, Altshuler L, Leiderman DB, Balish M, Ketter TA, Devinsky O, Post RM, Theodore WH. Cerebral metabolism and depression in patients with complex partial seizures. Arch Neurol. 1992 Jun;49(6):617-23. doi: 10.1001/archneur.1992.00530300049010.
PubMed 1596197Kanner AM. Depression in epilepsy: prevalence, clinical semiology, pathogenic mechanisms, and treatment. Biol Psychiatry. 2003 Aug 1;54(3):388-98. doi: 10.1016/s0006-3223(03)00469-4.
PubMed 12893113Lambert MV, Robertson MM. Depression in epilepsy: etiology, phenomenology, and treatment. Epilepsia. 1999;40 Suppl 10:S21-47. doi: 10.1111/j.1528-1157.1999.tb00884.x.
PubMed 10609603
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Serotoninergic Neurotransmission in Epilepsy
- ClinicalTrials.gov ID
- NCT00439387
- Acronym / sponsor ID
- 070103
- Keywords
- Serotonin, Epilepsy, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 20 Feb 2007
- Study completion
- 5 Jun 2015
- First posted
- 23 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the role that a brain chemical called serotonin plays in seizures. Serotonin, present naturally in the brain, helps transmit signals between nerve cells. Glucose is a sugar that is the main fuel of the brain. Studying these two chemicals may help explain why people with epilepsy get seizures and are more likely to be depressed.
Healthy volunteers and patients 18 to 60 years of age who have epilepsy with or without depression and whose seizures are not controlled by medication may be eligible for this study. Candidates are screened with a review of their medical history, a physical examination and an electroencephalogram (EEG, brain wave recording).
Participants undergo the following procedures:
- Positron emission tomography (PET) scans: The first of three PET scans measures brain blood flow and the activity at some of the brain serotonin receptors (the parts of brain cells to which serotonin attaches). A second scan measures the amount of serotonin transported between brain cells. A third scan measures glucose use. The PET scanner is shaped like a doughnut. The subject lies on a bed that slides in and out of the scanner with his or her head inside the opening. A special mask is fitted to the subject s head to help keep it still during the procedure so the images will be clear. For the first scan, catheters (plastic tubes) are placed in an arm vein to inject a radioactive substance and in an artery in the wrist to collect blood samples. The other two scans require only the catheter in the arm.
- Magnetic resonance imaging: This test uses a strong magnetic field and radio waves to obtain images of the brain. The scanner is a metal cylinder surrounded by a strong magnetic field. The subject lies on a table that can slide in and out of the cylinder. Most scans last between 45 and 90 minutes. Subjects wear earplugs to muffle loud knocking noises that occur during scanning.
- Psychological evaluation: Subjects are interviewed and fill out questionnaires to help study sadness and depression in epilepsy.
- Blood draw: Blood tests look for differences in genes between people with epilepsy who are depressed and those who are not.
Detailed description
Objective: To study serotonergic transmission in epilepsy and its relation to cerebral glucose metabolism, mesial temporal sclerosis, and depression.
Study population: Patients with localization-related epilepsy with and without depression, and generalized epilepsy, and normal controls, ages 18-60.
Design: This is a neuroimaging study using positron emission tomography with a 5HT(1A) receptor ligand, 18F-FCWAY, a serotonin transporter ligand, 11C-DASB, and 15O-H2O for cerebral blood flow estimation. Patients will have measurements of cerebral glucose metabolism using 18F-FDG as well. Magnetic resonance imaging will be performed for examination of hippocampal structure and partial volume correction. Screening for depression will be performed by NIMH investigators. We will measure cortisol and ACTH levels, which may affect hippocampal structure and function. Testing for genetic markers that may predict serotonin transporter activity and depression will be performed.
Outcome measures: 5HT(1A) receptor binding, serotonin transporter activity, cerebral blood flow, and, in patients, glucose metabolism and hippocampal structure. Patients will be stratified by seizure type and depression ratings.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
Key exclusion criteria (13 listed)
- Patients younger than 18 or older than 60 years old. There is evidence for reduced 5HT1A receptor binding in patients over 60.
- Patients with a known treatable seizure etiology such as neoplastic or infectious disease.
- Patients with MRI findings consistent with brain tumors, trauma or AVMs.
- Patients with progressive neurologic disorders.
- Patients with a history of significant medical disorders, or requiring treatment with drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Background: PubMed 1596197Bromfield EB, Altshuler L, Leiderman DB, Balish M, Ketter TA, Devinsky O, Post RM, Theodore WH. Cerebral metabolism and depression in patients with complex partial seizures. Arch Neurol. 1992 Jun;49(6):617-23. doi: 10.1001/archneur.1992.00530300049010.
- Background: PubMed 12893113Kanner AM. Depression in epilepsy: prevalence, clinical semiology, pathogenic mechanisms, and treatment. Biol Psychiatry. 2003 Aug 1;54(3):388-98. doi: 10.1016/s0006-3223(03)00469-4.
- Background: PubMed 10609603Lambert MV, Robertson MM. Depression in epilepsy: etiology, phenomenology, and treatment. Epilepsia. 1999;40 Suppl 10:S21-47. doi: 10.1111/j.1528-1157.1999.tb00884.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William H Theodore, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Seizures, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00439387, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.