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Not yet recruiting NCT07307768

Ketamine Biomarker Validation

Phase I Interventional Treatment Resistant Depression (TRD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketamine (0.25 mg/kg), Ketamine (0.5 mg/kg), Ketamine (0.75 mg/kg).
Who it may be relevant to
Registry conditions: Treatment Resistant Depression (TRD). Basic parameters: 18 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

EEG Biomarker Development for Ketamine Administration

Overview

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.

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.

Interventions

  • Drug Ketamine (0.25 mg/kg)
    Low level ketamine infusion therapy.
  • Drug Ketamine (0.5 mg/kg)
    Medium level ketamine infusion therapy.
  • Drug Ketamine (0.75 mg/kg)
    High level ketamine infusion therapy.

Primary outcome measures

  • Hamilton Depression Rating Scale (HDRS) 22 [Time frame: Baseline, Hour 1, Hour 4, Hour 24, and Hour 72]
Secondary outcome measures (3)
  • The Columbia Suicidality Severity Rating Scale (C-SSRS) [Time frame: Baseline, Hour 1, Hour 4, Hour 24, and Hour 72]
  • The Clinician Administered Dissociative States Scale (CADSS) [Time frame: Baseline, and Hour 1]
  • Montgomery-Asberg Depression Rating Scale (MADRS) [Time frame: Baseline and Hour 24]

Eligibility criteria

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,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Columbia University Irving Medical Center — New York

Identifiers

NCT: NCT07307768 · KETAEEG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗