Ketamine Biomarker Validation

Soterix Medical

Status and phase: Not yet enrolling; Phase 1

Conditions: Treatment Resistant Depression (TRD)

Treatments: Drug: Ketamine (0.75 mg/kg); Drug: Ketamine (0.25 mg/kg); Drug: Ketamine (0.5 mg/kg)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07307768

KETAEEG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 3 patient groups

Low level ketamine

Experimental group

Description:

0.25 mg/kg ketamine infusion

Treatment:

Drug: Ketamine (0.25 mg/kg)

Medium level ketamine

Experimental group

Description:

0.5 mg/kg ketamine infusion

Treatment:

Drug: Ketamine (0.5 mg/kg)

High level ketamine

Experimental group

Description:

0.75 mg/kg ketamine infusion

Treatment:

Drug: Ketamine (0.75 mg/kg)