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Not yet recruitingPhase 1

Ketamine Biomarker Validation

NCT07307768 · Soterix Medical

Closed to entry
Status
Not accepting participants
Phase 1
Phase
20
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Hamilton Depression Rating Scale (HDRS) 22

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

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 59 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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,

Where

1 study site

FacilityCityRegionCountry
Columbia University Irving Medical CenterNew YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07307768 on ClinicalTrials.gov →

Last updated in the registry 2025-12-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits