drugset / Trial / NCT04928703
Effects of Ketamine on ERP/EEG Measures in Healthy Volunteers
Phase 0
Completed
33 enrolled
ERP Biomarker Qualification Consortium
Alkermes, Inc. · collabAnavex Life Sciences Corp. · collabApex Innovative Sciences · collabAstellas Pharma Inc · collabCOGNISION · collabH. Lundbeck A/S · collabMerck Sharp & Dohme LLC · collabNovartis · collabSage Therapeutics · collabTakeda · collab
RandomizedCrossoverTriple-blindOther
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.
Timeline
- Start
- 2022-05-26
- Primary completion
- 2022-12-12
- Completion
- 2022-12-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | — | Intravenous |
Indications
No indication recorded.