EEG Characteristics in ECT

NCT04022226 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: 19-228
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Electroconvulsive Therapy; Direct Current Electroencephalogram; Ketamine; Spreadind Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

Methohexital

ACTIVE COMPARATOR

Standard of care anesthesia that does not affect slow wave characteristics

Drug: Methohexital

Ketamine

EXPERIMENTAL

Standard of care anesthesia that suppresses slow wave characteristics

Drug: Ketamine

Interventions

Ketamine DRUG

Induction agent that suppresses infra-slow waves

Ketamine

Methohexital DRUG

Induction agent that does not suppress infra-slow waves

Methohexital

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Mental Health Center

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Interventions

Ketamine; Methohexital

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jeremy Miller
• Organization: The University of New Mexico

jermiller@salud.unm.edu

5052724490

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Psychiatrist

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 17, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 26, 2024
• Results First Posted: October 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: An embargo of 2 years will be placed on the data after Master's Thesis is published and placed into the vault to allow for publications. Afterwards, it will be available as along as the vault is maintained.
• Access Criteria: Pilot project is being done as a part of a Master's Thesis which will be uploaded to the University of New Mexico digital repository and may contain supporting information as above.

Locations

US (1)