Health TrialsbyHealthPanel

Ketamine Biomarker Validation

ConditionTreatment Resistant Depression (TRD)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-59
SponsorSoterix Medical

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Low level ketamineExperimental treatment 1 intervention
Group B: Medium level ketamineExperimental treatment 1 intervention
Group C: High level ketamineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

Montgomery-Asberg Depression Rating Scale (MADRS)

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

Time frame
Baseline and Hour 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Soterix Medical

Lead sponsor

Columbia University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: