Ketamine Biomarker Validation

NCT07307768 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: KETAEEG
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Ketamine; EEG; Depression; MDD; unipolar Depression; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Columbia Suicidality Severity Rating Scale (C-SSRS)

  Baseline, Hour 1, Hour 4, Hour 24, and Hour 72

• The Clinician Administered Dissociative States Scale (CADSS)

  Baseline, and Hour 1

• Montgomery-Asberg Depression Rating Scale (MADRS)

  Baseline and Hour 24

Study Arms (3)

Low level ketamine

EXPERIMENTAL

0.25 mg/kg ketamine infusion

Drug: Ketamine (0.25 mg/kg)

Medium level ketamine

EXPERIMENTAL

0.5 mg/kg ketamine infusion

Drug: Ketamine (0.5 mg/kg)

High level ketamine

EXPERIMENTAL

0.75 mg/kg ketamine infusion

Drug: Ketamine (0.75 mg/kg)

Interventions

Ketamine (0.25 mg/kg) DRUG

Low level ketamine infusion therapy.

Low level ketamine

Ketamine (0.5 mg/kg) DRUG

Medium level ketamine infusion therapy.

Medium level ketamine

Ketamine (0.75 mg/kg) DRUG

High level ketamine infusion therapy.

High level ketamine

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Soterix Medical: lead
• Columbia University Irving Medical Center, New York, NY: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression; Depressive Disorder

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Yishai Valter, MS

CONTACT

8889908327; trials@soterixmedical.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)