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Ketamine Biomarker Validation

NCT07307768 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-29

No results posted yet for this study

Summary

We will be developing an EEG-based biomarker for the effects of ketamine infusion in patients with Depression. We will be analyzing the effects of ketamine infusion on Depression symptoms and EEG signals.

Conditions

  • Treatment Resistant Depression (TRD)

Interventions

DRUG

Ketamine (0.25 mg/kg)

Low level ketamine infusion therapy.

DRUG

Ketamine (0.5 mg/kg)

Medium level ketamine infusion therapy.

DRUG

Ketamine (0.75 mg/kg)

High level ketamine infusion therapy.

Sponsors & Collaborators

  • Columbia University Irving Medical Center, New York, NY

    collaborator UNKNOWN

  • Soterix Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-20
Primary Completion
2027-12-01
Completion
2028-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07307768 on ClinicalTrials.gov