Ketamine Biomarker Validation

EEG Biomarker Development for Ketamine Administration

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Treatment Resistant Depression (TRD)
• Intervention / Treatment: Drug: Ketamine (0.25 mg/kg); Drug: Ketamine (0.5 mg/kg); Drug: Ketamine (0.75 mg/kg)

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yishai Valter, MS; Phone Number: 8889908327; Email: trials@soterixmedical.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
      • Contact: Yishai Valter, MS; Phone Number: 8889908327; Email: trials@soterixmedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Physically healthy patients who meet DMS-5 criteria for a major depressive episode (MDE) in the context of MDD and who score at least 22 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
• If taking antidepressants, dose is stable for at least 6 weeks.

Exclusion Criteria:

• Lifetime history of bipolar disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder, including MDD with psychotic features
• A first-degree relative with bipolar disorder, schizoaffective disorder, or schizophrenia, with the potential participant younger than 33 years (i.e., still at age of risk for a psychotic disorder)
• Receipt of electroconvulsive therapy within 3 months of enrolling in the study
• History of IV drug use
• Nonresponse or intolerance to ketamine administered either clinically or as part of a prior research study
• Pregnancy, planning to conceive, or sexually active but not using adequate birth control.
• Actively suicidal (CSSRS≥3)
• No antipsychotics or medications (e.g. benzodiazepines, anti-epileptics) that are likely to interact with GABA or glutamate,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low level ketamine; 0.25 mg/kg ketamine infusion	Drug: Ketamine (0.25 mg/kg); Low level ketamine infusion therapy.
Experimental: Medium level ketamine; 0.5 mg/kg ketamine infusion	Drug: Ketamine (0.5 mg/kg); Medium level ketamine infusion therapy.
Experimental: High level ketamine; 0.75 mg/kg ketamine infusion	Drug: Ketamine (0.75 mg/kg); High level ketamine infusion therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale (HDRS) 22	Twenty-two question Depression rating scale (excluding the two questions on weight loss and diurnal variation)	Baseline, Hour 1, Hour 4, Hour 24, and Hour 72

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Columbia Suicidality Severity Rating Scale (C-SSRS)	A semi-structured, investigator-rated interview assessing both suicidal behavior and suicidal ideation.	Baseline, Hour 1, Hour 4, Hour 24, and Hour 72
The Clinician Administered Dissociative States Scale (CADSS)	A scale that rates dissociative symptoms with a 27-item scale, rated 0-4, 19 subjective, and 8 observer items	Baseline, and Hour 1
Montgomery-Asberg Depression Rating Scale (MADRS)	A ten-item diagnostic used for the assessment of depression severity	Baseline and Hour 24

Collaborators and Investigators

• Sponsor: Soterix Medical
• Collaborators: Columbia University Irving Medical Center, New York, NY

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Biomarker; Depression; Ketamine; MDD; EEG; unipolar Depression
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Behavior; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant; Organic Chemicals; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Ketamine
• Other Study ID Numbers: KETAEEG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No