Completed EARLY_PHASE1 INTERVENTIONAL 3-arm NCT04928703

Effects of Ketamine on ERP/EEG Measures in Healthy Volunteers

A Phase 0, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Assess Ketamine-induced Changes in ERP Biomarkers in Healthy Volunteers

Sponsor: Alkermes, Inc.

Conditions Healthy

Interventions Ketamine

Updated 8 times since 2021 Last updated: Feb 17, 2023 Started: May 26, 2022 Primary completion: Dec 12, 2022 Completion: Dec 12, 2022

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This EARLY_PHASE1 trial investigates Healthy and is currently completed. Alkermes, Inc. leads this study, which shows 8 recorded versions since 2022 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Completed EARLY_PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed EARLY_PHASE1
Mar 2023 — Jul 2024 [monthly]

Completed EARLY_PHASE1
Jan 2023 — Mar 2023 [monthly]

Completed EARLY_PHASE1

Status: Recruiting → Completed
Jul 2022 — Jan 2023 [monthly]

Recruiting EARLY_PHASE1

Status: Not Yet Recruiting → Recruiting

▶ Show 3 earlier versions

Jun 2022 — Jul 2022 [monthly]

Not Yet Recruiting EARLY_PHASE1
May 2022 — Jun 2022 [monthly]

Not Yet Recruiting EARLY_PHASE1
Sep 2021 — May 2022 [monthly]

Not Yet Recruiting EARLY_PHASE1

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Alkermes, Inc.
Anavex Life Sciences Corp.
Apex Innovative Sciences
Astellas Pharma Inc
COGNISION
ERP Biomarker Qualification Consortium
H. Lundbeck A/S
Merck Sharp & Dohme LLC
Novartis
Sage Therapeutics
Takeda

Data source: ERP Biomarker Qualification Consortium

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Marlton, United States