Trial Outcomes & Findings for EEG Characteristics in ECT (NCT NCT04022226)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

11 participants

Primary outcome timeframe

1 year

Results posted on

2024-10-26

Participant Flow

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.

We had initially envisioned this as a randomized trial, but due to COVID, we restricted it to a single-arm study.

Participant milestones

Participant milestones
Measure	Methohexital Standard of care anesthesia that does not affect slow wave characteristics Methohexital: Induction agent that does not suppress infra-slow waves
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methohexital n=11 Participants Standard of care anesthesia that does not affect slow wave characteristics Methohexital: Induction agent that does not suppress infra-slow waves
Age, Categorical <=18 years	0 Participants n=11 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=11 Participants
Age, Categorical >=65 years	0 Participants n=11 Participants
Sex: Female, Male Female	7 Participants n=11 Participants
Sex: Female, Male Male	4 Participants n=11 Participants
Region of Enrollment United States	11 Participants n=11 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Methohexital n=11 Participants Standard of care anesthesia that does not affect slow wave characteristics Methohexital: Induction agent that does not suppress infra-slow waves
Number of Participants Assessed for Clinical Efficacy of ECT	11 Participants

Adverse Events

Methohexital

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeremy Miller

The University of New Mexico

Phone: 5052724490

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place