Early Phase 1 N=11 Randomized Double-blind Diagnostic

EEG Characteristics in ECT

Electroconvulsive Therapy · Direct Current Electroencephalogram · Ketamine · Spreadind Depression

Bottom Line

View on ClinicalTrials.gov: NCT04022226 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Number of Participants Assessed for Clinical Efficacy of ECT — 11 Participants

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Ketamine (Drug); Methohexital (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of New Mexico
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Assessed for Clinical Efficacy of ECT	11	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04022226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.