Treatment Resistant Depression (TRD)
Conditions
Keywords
Ketamine, EEG, Depression, MDD, unipolar Depression, Biomarker
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.
Interventions
Low level ketamine infusion therapy.
Medium level ketamine infusion therapy.
DRUGKetamine (0.75 mg/kg)
High level ketamine infusion therapy.
Sponsors
Columbia University Irving Medical Center, New York, NY
Soterix Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale (HDRS) 22 | 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
| Measure | Time frame | Description |
|---|---|---|
| The Columbia Suicidality Severity Rating Scale (C-SSRS) | Baseline, Hour 1, Hour 4, Hour 24, and Hour 72 | A semi-structured, investigator-rated interview assessing both suicidal behavior and suicidal ideation. |
| The Clinician Administered Dissociative States Scale (CADSS) | Baseline, and Hour 1 | A scale that rates dissociative symptoms with a 27-item scale, rated 0-4, 19 subjective, and 8 observer items |
| Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline and Hour 24 | A ten-item diagnostic used for the assessment of depression severity |
Countries
United States
Contacts
Primary ContactYishai Valter, MS
Outcome results
None listed