NCT07307768

Ketamine Biomarker Validation

EEG Biomarker Development for Ketamine Administration

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Soterix Medical · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is a biomarker development study. We will be examining the effects of various doses of ketamine infusion on depressive symptoms and EEG signals in patients with unipolar depression.

Conditions

• Treatment Resistant Depression (TRD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-20
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study