Effects of Ketamine on ERP/EEG Measures in Healthy Volunteers

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.

Conditions

• Healthy

Interventions

DRUG

Ketamine

Ketamine IV administration

Sponsors & Collaborators

• Alkermes, Inc.

  collaborator INDUSTRY

• Anavex Life Sciences Corp.

  collaborator INDUSTRY

• Astellas Pharma Inc

  collaborator INDUSTRY

• H. Lundbeck A/S

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Novartis

  collaborator INDUSTRY

• Sage Therapeutics

  collaborator INDUSTRY

• Takeda

  collaborator INDUSTRY

• Apex Innovative Sciences

  collaborator UNKNOWN

• COGNISION

  collaborator UNKNOWN

• ERP Biomarker Qualification Consortium

  lead INDUSTRY

Principal Investigators

• Marco Cecchi, PhD · The ERP Biomarker Qualification Consortium

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-26

Primary Completion

2022-12-12

Completion

2022-12-12

Countries

• United States

Study Locations