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NCT07307768WithdrawnPhase 1

Ketamine Biomarker Validation

EEG Biomarker Development for Ketamine Administration

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Reason given: Funding was not provided

Brief summary (registry, in English)

An EEG-based biomarker will be developed for the effects of ketamine infusion in patients with Depression. The effects of ketamine infusion on Depression symptoms and EEG signals will be analyzed.

Status (registry)
Withdrawn
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
0 (actual)
First submitted
15 Dec 2025
Start date
20 Dec 2025
Primary completion date
1 Dec 2027
Lead sponsor
Soterix Medical
Diseases
Depression
NCT number
NCT07307768

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receipt of electroconvulsive therapy within 3 months of enrolling in the study
  • Nonresponse or intolerance to ketamine administered either clinically or as part of a prior research study
  • No antipsychotics or medications (e.g. benzodiazepines, anti-epileptics) that are likely to interact with GABA or glutamate,

Other illness

  • Lifetime history of bipolar disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder, including MDD with psychotic features
  • History of IV drug use

Age

  • 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)

Other

  • Pregnancy, planning to conceive, or sexually active but not using adequate birth control.
  • Actively suicidal (CSSRS≥3)

Who the study is looking for

  • 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.

Age in the registry: 18 years to 59 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Columbia University Irving Medical CenterNew YorkUnited StatesUnknown status

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