Not Yet RecruitingPhase 1ketamine

Ketamine Biomarker Validation

Sponsored by Soterix Medical

NCT ID
NCT07307768
Target Enrollment
20 participants
Start Date
2025-12-20
Est. Completion
2028-03-01

About This Study

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 Studied

Treatment Resistant Depression (TRD)

Interventions

  • Ketamine (0.25 mg/kg)
  • Ketamine (0.5 mg/kg)
  • Ketamine (0.75 mg/kg)

Eligibility

Age:18 Years - 59 Years
Healthy Volunteers:No
View full 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,

Study Locations (1)

Columbia University Irving Medical Center
New York, New York, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Yishai Valter, MS
CONTACT
8889908327trials@soterixmedical.com
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source

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