Electroconvulsive Therapy, Direct Current Electroencephalogram, Ketamine, Spreadind Depression
Conditions
Brief summary
The investigators will be examining slow-wave characteristics in depressed patients receiving electroconvulsive therapy (ECT) using direct current electroencephalogram (dcEEG) by anesthesia induction agent.
Detailed description
This is a pilot project using dcEEG to look at infra-slow waves in depressed patients receiving ECT randomized to ketamine or methohexital where ketamine suppresses infra-slow waves. The rationale for this project is to identify biomarkers of treatment adequacy in ECT, which could lead to decreased morbidity and mortality with the procedure and lessen the burden of depression in our patient population.
Interventions
DRUGKetamine
Induction agent that suppresses infra-slow waves
DRUGMethohexital
Induction agent that does not suppress infra-slow waves
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Structured Clinical Interview for DSM-5 will confirm diagnosis of MDD or BPD-depressed (with or without psychotic features * The clinical indications for ECT including treatment resistance or a need for a rapid and definitive response; * Hamilton Depression Rating Scale 24-item (HDRS-24) \> 21; and * Age range between 18 and 65 years of age.
Exclusion criteria
* Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness \> 5 minutes, epilepsy, Alzheimer's disease); * Other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder) * Current drug or alcohol use disorder, except for nicotine and marijuana * Adults unable to consent, pregnant women, prisoner * Non-English speakers * Patients that cannot tolerate Methohexital and Ketamine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Assessed for Clinical Efficacy of ECT | 1 year | Quick Inventory of Depressive Symptomatology (QIDS) and Self Reporting version (QIDS-SR) - Range 0 - 48 with higher number indicating worsening depression. Inadequate sample size due to COVID. Study was closed. |
Countries
United States
Participant flow
Recruitment details
The funding cycle was cut short secondary to COVID and it was decided to analyze DCEEG Characteristics with only one arm, the Methohexital arm (standard of care). The Ketamine arm was cancelled.
Pre-assignment details
We had initially envisioned this as a randomized trial, but due to COVID, we restricted it to a single-arm study.
Participants by arm
| Arm | Count |
|---|---|
| Methohexital Standard of care anesthesia that does not affect slow wave characteristics
Methohexital: Induction agent that does not suppress infra-slow waves | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Methohexital | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 11 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 11 Participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Number of Participants Assessed for Clinical Efficacy of ECT
Quick Inventory of Depressive Symptomatology (QIDS) and Self Reporting version (QIDS-SR) - Range 0 - 48 with higher number indicating worsening depression. Inadequate sample size due to COVID. Study was closed.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methohexital | Number of Participants Assessed for Clinical Efficacy of ECT | 11 Participants |