Ketamine Biomarker Validation

Phase 1Not Yet RecruitingNCT07307768

Soterix Medical20 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Treatment Resistant Depression (TRD)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

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,

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale (HDRS) 22

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

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

Secondary Outcomes

The Columbia Suicidality Severity Rating Scale (C-SSRS)

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

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

The Clinician Administered Dissociative States Scale (CADSS)

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

Time frame: Baseline, and Hour 1

Montgomery-Asberg Depression Rating Scale (MADRS)

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

Time frame: Baseline and Hour 24

Central Contacts

Yishai Valter, MS

CONTACT

8889908327 trials@soterixmedical.com

Data from ClinicalTrials.gov

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