Effects of Ketamine on ERP/EEG Measures in Healthy Volunteers (NCT04928703) | Clinical Trial Compass
CompletedEarly Phase 1
Effects of Ketamine on ERP/EEG Measures in Healthy Volunteers
United States33 participantsStarted 2022-05-26
Plain-language summary
This is a Phase 0, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to assess the changes in ERP Biomarkers in Healthy Volunteers before and after administration of a sub-anesthetic dose of ketamine. Primary objectives are to quantify the effect size of ketamine-induced changes on MMN from a duration-deviant auditory oddball ERP test and to quantify the variability of ketamine-induced changes on MMN from a duration-deviant auditory oddball ERP test.
Who can participate
Age range21 Years – 40 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy male and female subjects 21-40 years of age, inclusive at Visit 1 (Screening).
✓. Female subjects with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (e.g., oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the study and for 30 days after the last dose of ketamine.
✓. Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
✓. Subject is judged to be in good health as determined by the investigator.
✓. Body mass index (BMI ) between 18.5 and 30.0 (inclusive) at Visit 1 (Screening).
✓. Ability to detect a 1000 and 2000 Hz tone at 40 dB in both ears, at Visit 1 (Screening).
✓. Ability to tolerate the electrode cap for the duration of the testing session.
Exclusion criteria
✕. Clinically significant alcohol or other substance abuse within the last 1 year, in the opinion of the investigator; or unable to abstain from alcoholic beverages during the course of the study.
✕. Positive alcohol/drug screen for drugs of abuse (with the exception of a positive result considered by the investigator to be directly attributable to prescription medication approved for subject use) such as phencyclidine, benzodiazepines, opiates, cocaine, cannabinoids, amphetamines, and cotinine at any Visit.
What they're measuring
1
Ketamine-induced changes in Amplitude for parameters from the ERP tests.
. Excessive caffeine use (defined as habitual consumption of \> 400 mg caffeine per day \[\~ four 8 oz. cups brewed caffeinated coffee or tea, \~ ten 12 oz. cans caffeinated soda or \~ two "energy shot" drinks\]), or unable to abstain from caffeine on Visits 2-4.
✕. Use of products containing nicotine (tobacco or vaping products) 60 minutes prior to dosing on Visits 2-4.
✕. Current or prior history (defined as in the past 6 months) of treatment with N-methyl-D-aspartate receptor (NMDAR) ligands including ketamine, amantadine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
✕. History of allergy, sensitivity, or intolerance to NMDAR ligands including ketamine, amantadine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
✕. Any impairment, activity, or situation that in the judgment of the investigator would prevent satisfactory completion of the study protocol.
✕. History of significant psychiatric, neurologic (e.g. Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, Type I or Type II diabetes mellitus, or a history of seizures, epilepsy, or strokes), or cognitive disorders (e.g. bipolar, schizophrenia, psychosis), or current (within 12 months prior to screening) psychiatric or cognitive disorders such as major depression, suicidal ideation, dementia, or anxiety disorders).