Status:
COMPLETED
Effects of L-theanine on Motor Cortex Excitability in Healthy Subjects: A Paired-Pulse TMS Study
Lead Sponsor:
Butler Hospital
Conditions:
Cortical Excitability
Psychiatric Disorder
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
Major depressive disorder (MDD) is a serious mental illness and the leading cause of disability worldwide. New pharmacotherapeutic agents with complementary neurobiological mechanism and better side e...
Detailed Description
Background and Significance: Major depressive disorder (MDD) is a serious mental illness and the leading cause of disability worldwide. Although many antidepressants acting on synaptic monoamine leve...
Eligibility Criteria
Inclusion
- Adult, aged between 18 and 65 years old;
- Able to read/speak English and give informed consent
- No current or history of Axis I psychiatric disorders by DSM-5.
- Free of psychotropic medication use
Exclusion
- History of significant acute or chronic neurological or medical disorder or condition that increases risk for seizure with TMS;
- History of alcohol use disorder, nicotine dependence, adjustment disorder;
- History of allergic reactions to L-theanine or green tea;
- Pregnancy;
- Unable/unwilling to abstain from nutraceutical supplements and psychotropic agents during participation in the study
- Unable/ unwillingness to refrain from recreational substance use (e.g. alcohol or marijuana) during participation in the study;
- Meet criteria for exclusion from TMS or MRI procedures, including intracranial metal implants or nonremovable ferromagnetic items in the head/neck.
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04749745
Start Date
June 9 2020
End Date
May 31 2021
Last Update
September 23 2021
Active Locations (1)
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1
Butler Hospital
Providence, Rhode Island, United States, 02906