EEG Biomarker Development for Ketamine Administration
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Hamilton Depression Rating Scale (HDRS) 22
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
Arms & Interventions
Low level ketamine
0.25 mg/kg ketamine infusion
Intervention: Ketamine (0.25 mg/kg) (Drug)
Medium level ketamine
0.5 mg/kg ketamine infusion
Intervention: Ketamine (0.5 mg/kg) (Drug)
High level ketamine
0.75 mg/kg ketamine infusion
Intervention: Ketamine (0.75 mg/kg) (Drug)
Outcomes
Primary Outcomes
Hamilton Depression Rating Scale (HDRS) 22
Time Frame: Baseline, Hour 1, Hour 4, Hour 24, and Hour 72
Twenty-two question Depression rating scale (excluding the two questions on weight loss and diurnal variation)
Secondary Outcomes
- The Columbia Suicidality Severity Rating Scale (C-SSRS)(Baseline, Hour 1, Hour 4, Hour 24, and Hour 72)
- Montgomery-Asberg Depression Rating Scale (MADRS)(Baseline and Hour 24)
- The Clinician Administered Dissociative States Scale (CADSS)(Baseline, and Hour 1)