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NCT Number: NCT07307768

Ketamine Biomarker Validation

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location contact

Yishai Valter, MS

CONTACT

[email protected]

8889908327

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Ketamine (0.25 mg/kg)

Drug

Low level ketamine infusion therapy.

Ketamine (0.5 mg/kg)

Drug

Medium level ketamine infusion therapy.

Ketamine (0.75 mg/kg)

Drug

High level ketamine infusion therapy.

Primary outcomes

  1. Hamilton Depression Rating Scale (HDRS) 22

    Time frame: Baseline, Hour 1, Hour 4, Hour 24, and Hour 72

    Twenty-two question Depression rating scale (excluding the two questions on weight loss and diurnal variation)

Secondary outcomes

  1. The Columbia Suicidality Severity Rating Scale (C-SSRS)

    Time frame: Baseline, Hour 1, Hour 4, Hour 24, and Hour 72

    A semi-structured, investigator-rated interview assessing both suicidal behavior and suicidal ideation.

  2. The Clinician Administered Dissociative States Scale (CADSS)

    Time frame: Baseline, and Hour 1

    A scale that rates dissociative symptoms with a 27-item scale, rated 0-4, 19 subjective, and 8 observer items

  3. Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: Baseline and Hour 24

    A ten-item diagnostic used for the assessment of depression severity

Study contacts

Contact information is provided by the study sponsor or research team.

Yishai Valter, MS

CONTACT

[email protected]

8889908327

Sponsors and collaborators

Lead sponsor

Soterix Medical

Industry

Collaborators

  • Columbia University

Registry information

Official study title

EEG Biomarker Development for Ketamine Administration

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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