Clinical Trials Logo

Clinical Trial Summary

Background: Buspirone is a drug that is approved for the treatment of anxiety in adults. Studies suggest that buspirone might act on parts of the brain that can increase certain levels of brain activity. Increasing this brain activity may help decrease epileptic seizures that come from certain parts of the brain. Researchers want to see if buspirone can reduce seizure frequency in people with seizures who are already taking antiseizure medication. Objectives: To test whether buspirone can reduce the frequency of seizures in people whose seizures seem to start from one part of the brain. Eligibility: Individuals between 18 and 65 years of age who have seizures coming from one or more places in the brain. Participants must have tried at least two different antiseizure medications. Participants must also have had at least three seizures during a 1-month observation period while on current medicines. Design: Participants will have a screening visit with a physical exam and medical history. Participants will complete mood and memory testing scales. Blood, urine, and saliva samples will be collected. Participants will have a magnetic resonance imaging scan to evaluate brain structures that relate to epilepsy. They will also have a positron emission tomography scan to look at parts of the brain that are affected by buspirone. Participants will start taking a study drug (either buspirone or placebo) twice daily. They will keep a calendar of seizures and record any side effects. Treatment will be monitored with clinic visits and blood samples. After 12 weeks on the study drug, participants will gradually stop taking either the placebo or buspirone over two weeks. They will stay off the drug for another 2 weeks. After 2 weeks, participants will start taking a study drug that is the opposite of the one they had before. They will keep a calendar of seizures and record any side effects. Treatment will be monitored with clinic visits and blood samples. After 12 weeks on the study drug, participants will gradually stop taking either the placebo or buspirone. Participants will have a final followup visit with additional blood tests, mood and memory testing scales and imaging studies.


Clinical Trial Description

OBJECTIVE: To initiate a pilot clinical trial assessing the safety, tolerability and efficacy of the 5HT1A receptor agonist buspirone in patients with localization-related epilepsy. Buspirone is a 5HT1A receptor agonist that is approved for the treatment of anxiety disorders. Patients with localization-related epilepsy have reduced 5HT1A receptor binding on 18FCWAY positron emission tomography (PET). Increasing neurotransmitter activity at 5HT1A receptor sites may ameliorate seizures. STUDY POPULATION: Forty patients with localization-related epilepsy DESIGN: A randomised, double-blind, placebo-controlled cross-over, phase II clinical trial. The trial will have a screening phase in which each patient will undergo physical and neurological examination, and standard blood tests, followed by a one month baseline phase. At the end of baseline, patients who qualify will have neuropsychological, anxiety, and mood evaluation, FCWAY PET and MRI (if imaging was not performed already). During the subsequent first study phase, patients will be randomized to buspirone or matching placebo. After completion of the first study phase, patients will be crossed over to the alternate study arm. At the end of the study, any patient who wishes to do so may remain on open-label buspirone. OUTCOME MEASURES: 1. Difference in seizure rate comparing the 3 month placebo and active study phases 2. Neuropsychological, anxiety, and mood indices comparing the 3 month placebo and active study drug phases ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01496612
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Terminated
Phase Phase 2
Start date November 22, 2011
Completion date April 19, 2016

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A