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Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia (RCC2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02761330
Recruitment Status : Completed
First Posted : May 4, 2016
Results First Posted : June 28, 2021
Last Update Posted : June 28, 2021
Sponsor:
Collaborator:
James S McDonnell Foundation
Information provided by (Responsible Party):
Ben Palanca, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Conditions Depression
Delirium
Seizures
Cognitive Disorders
Interventions Drug: Ketamine
Procedure: Electroconvulsive Therapy
Enrollment 17
Recruitment Details 17 patients were enrolled for study participation between May 2016 and July 2018 at Barnes Jewish Hospital in St. Louis, MO.
Pre-assignment Details 14 of 17 participants were randomized. Of those not randomized, 1 participant's treatment course was canceled by clinical staff, 1 participant withdrew consent prior to any study participation, and 1 participant was deemed ineligible.
Arm/Group Title Ketamine +ECT, Etomidate + ECT, Ketamine Sham Ketamine +ECT, Ketamine Sham, Etomidate + ECT Etomidate +ECT, Ketamine + ECT, Ketamine Sham Etomidate +ECT, Ketamine Sham, Ketamine +ECT Ketamine Sham, Etomidate +ECT, Ketamine +ECT Ketamine Sham, Ketamine +ECT, Etomidate +ECT
Hide Arm/Group Description

Participants first received ECT treatment under Ketamine general anesthesia, then ECT treatment under Etomidate anesthesia, and finally participants received Ketamine general anesthesia with sham ECT.

Ketamine+ECT: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine Sham: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Etomidate + ECT: General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Participants first received ECT treatment under Ketamine general anesthesia, then Ketamine general anesthesia with sham ECT and finally participants received ECT treatment under Etomidate anesthesia.

Ketamine+ECT: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine Sham: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Etomidate + ECT: General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Participants first received ECT treatment under Etomidate general anesthesia, then ECT treatment under Ketamine general anesthesia and finally participants received Ketamine general anesthesia with sham ECT.

Ketamine+ECT: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine Sham: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Etomidate + ECT: General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Participants first received ECT treatment under Etomidate general anesthesia, then Ketamine general anesthesia with sham ECT and finally participants received ECT treatment under Ketamine anesthesia.

Ketamine+ECT: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine Sham: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Etomidate + ECT: General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Participants first received Ketamine general anesthesia with sham ECT, then ECT treatment under Etomidate general anesthesia and finally participants received ECT treatment under Ketamine anesthesia.

Ketamine+ECT: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine Sham: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Etomidate + ECT: General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Participants first received Ketamine general anesthesia with sham ECT, then ECT treatment under Ketamine general anesthesia and finally participants received ECT treatment under Etomidate anesthesia.

Ketamine+ECT: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine Sham: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Etomidate + ECT: General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Period Title: Treatment Week 1
Started 2 3 2 3 1 3
Completed 2 3 2 2 1 2
Not Completed 0 0 0 1 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             1             0             1
Period Title: Treatment Week 2
Started 2 3 2 1 [1] 1 1 [2]
Completed 2 3 2 1 1 1
Not Completed 0 0 0 0 0 0
[1]
1 pt. in this group completed Week 1, but did not begin Week 2 due to withdraw.
[2]
1 pt. in this group completed Week 1, but did not begin Week 2 due to cancellation of treatment.
Arm/Group Title AllParticipants
Hide Arm/Group Description All participants enrolled in study procedures.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Per the participant flow report, 17 patients were enrolled in study procedures. Only 10 completed the study, per the full protocol, as reported. However, data from 15 participants are eligible for analyses. So, all analyses were done with 15 participants.
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
37  (13.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
8
  53.3%
Male
7
  46.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
15
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
15
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Change in Cognitive Function During Recovery: Rate of Recovery
Hide Description

A cognitive test battery was administered at 0, 30, 60, 90, and 120 minutes following return of consciousness after general anesthesia on each treatment day (1-6). The data from each treatment day (1-6) were averaged for analyses.

Cognition Test Battery:

  • Psychomotor Vigilance Task (PVT)
  • Digital Symbol Substitution Task (DSST)
  • Motor Praxis Task (MP)
  • Visual Object Learning Task (VOLT)
  • Abstract Matching (AM)

Rate of Recovery for this measure is defined as the time (in inverse hours) for participants to return to their baseline performance for each task.

Time Frame 0, 30, 60, 90, 120 minutes following return of consciousness, assessed on treatment days 1-6.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with cogntive task data complete for the majority of timepoints following return of responsiveness for more than one treatment day were included in analyses. Additional participants were excluded for individual cognitive task measures for being extreme outliers.
Arm/Group Title Etomidate + ECT Ketamine + ECT Ketamine Alone
Hide Arm/Group Description:

General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Overall Number of Participants Analyzed 9 9 11
Median (Inter-Quartile Range)
Unit of Measure: inverse hours
PVT Reaction Time Number Analyzed 7 participants 9 participants 11 participants
3.5
(2.2 to 4.0)
6.3
(5.4 to 7.1)
24.7
(8.1 to 27.5)
DSST Reaction Time Number Analyzed 8 participants 9 participants 11 participants
9.7
(6.8 to 10)
3.0
(2.2 to 3.1)
2.9
(2.4 to 3.7)
MP Reaction Time Number Analyzed 9 participants 9 participants 11 participants
3.9
(3.5 to 4.4)
2.5
(1.4 to 3.1)
2.6
(2.6 to 2.6)
VOLT Reaction Time Number Analyzed 9 participants 7 participants 11 participants
9.2
(8.9 to 9.3)
11.6
(5.2 to 12.8)
3.1
(2.8 to 3.3)
AM Reaction Time Number Analyzed 9 participants 9 participants 11 participants
4.8
(4.8 to 4.8)
1.6
(1.6 to 1.6)
2.3
(2.2 to 2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT, Ketamine + ECT
Comments Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT, Ketamine Alone
Comments Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT, Ketamine + ECT
Comments Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Digital Symbol Substitution Task (DSST) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT, Ketamine Alone
Comments Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Digital Symbol Substitution Task (DSST) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.203
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT, Ketamine + ECT
Comments Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Motor Praxis Task (MP) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT, Ketamine Alone
Comments Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Motor Praxis Task (MP) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.496
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT, Ketamine + ECT
Comments Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Visual Object Learning Task (VOLT) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.844
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT, Ketamine Alone
Comments Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Visual Object Learning Task (VOLT) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT, Ketamine + ECT
Comments Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Abstract Matching task (AM) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT, Ketamine Alone
Comments Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Abstract Matching task (AM) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
2.Primary Outcome
Title Change in Cognitive Function During Recovery: Initial Decrement
Hide Description

A cognitive test battery was administered at 0, 30, 60, 90, and 120 minutes following return of consciousness after general anesthesia on each treatment day (1-6). The data from each treatment day (1-6) were averaged for analyses.

Cognition Test Battery:

  • Psychomotor Vigilance Task (PVT)
  • Digital Symbol Substitution Task (DSST)
  • Motor Praxis Task (MP)
  • Visual Object Learning Task (VOLT)
  • Abstract Matching (AM)

Initial Decrement for this measure is defined as the difference between response times (in seconds) at baseline and t=0 for each task.

Time Frame 0, 30, 60, 90, 120 minutes following return of consciousness, assessed on treatment days 1-6.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with cogntive task data complete for the majority of timepoints following return of responsiveness for more than one treatment day were included in analyses. Additional participants were excluded for individual cognitive task measures for being extreme outliers.
Arm/Group Title Etomidate + ECT Ketamine + ECT Ketamine Alone
Hide Arm/Group Description:

General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Overall Number of Participants Analyzed 9 9 11
Median (Inter-Quartile Range)
Unit of Measure: seconds
PVT Initial Decrement Number Analyzed 7 participants 9 participants 11 participants
0.4
(0.4 to 0.4)
3.5
(2.4 to 5.7)
6.8
(1.3 to 8.2)
DSST Initial Decrement Number Analyzed 8 participants 9 participants 11 participants
2.4
(1.3 to 3.3)
5.1
(2.7 to 9.3)
3.1
(2.3 to 12.6)
MP Initial Decrement Number Analyzed 9 participants 9 participants 11 participants
1.9
(0.6 to 2.8)
3.0
(1.7 to 4.1)
2.4
(1.2 to 4.4)
VOLT Initial Decrement Number Analyzed 9 participants 7 participants 11 participants
4.9
(1.4 to 6.6)
20.9
(20.4 to 21.2)
6.5
(0.3 to 11.4)
AM Initial Decrement Number Analyzed 9 participants 9 participants 11 participants
3.2
(1.5 to 4.9)
2.0
(1.1 to 4.6)
6.7
(3.2 to 7.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT, Ketamine + ECT
Comments Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Psychomotor Vigilance Task (PVT) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT, Ketamine Alone
Comments Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT, Ketamine + ECT
Comments Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Digital Symbol Substitution Task (DSST) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT, Ketamine Alone
Comments Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Digital Symbol Substitution Task (DSST) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT, Ketamine + ECT
Comments Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Motor Praxis task (MP) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.195
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT, Ketamine Alone
Comments Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Motor Praxis task (MP) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.570
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT, Ketamine + ECT
Comments Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Visual Object Learning Task (VOLT) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT, Ketamine Alone
Comments Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Visual Object Learning Task (VOLT) reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT, Ketamine + ECT
Comments Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Abstract Matching (AM) task reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT, Ketamine Alone
Comments Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Abstract Matching (AM) task reaction time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
Comments Not adjusted for multiple comparisons.
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
3.Secondary Outcome
Title Delirium Incidence and Severity
Hide Description

Assessed using 3D Confusion Assessment Method (CAM).

The groups/arms for this outcome are separated by anesthetic regimen; however, due to the crossover design of this study all participants are included in analyses for each group.

Time Frame Immediately following return of consciousness (t=0) during treatment days 1-6.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants (12) who completed both baseline and t=0 delirium assessments on at least one treatment day.
Arm/Group Title Ketamine + ECT Etomidate + ECT Ketamine Alone
Hide Arm/Group Description:
General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.
General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.
General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.
Overall Number of Participants Analyzed 12 12 12
Overall Number of Units Analyzed
Type of Units Analyzed: Delirium Assessments
42 46 44
Measure Type: Number
Unit of Measure: Delirium Assessments
Positive Delirium at Baseline 1 0 0
Negative Delirium at Baseline 20 23 23
Positive Delirium at t=0 1 0 2
Negative Delirium at t=0 20 23 19
4.Secondary Outcome
Title Suicidality
Hide Description

The groups/arms for this outcome are combined as a whole-group analysis due to the crossover design of this study, as pre-specified by the study protocol. Breaking up the analyses into the various arms of the study would change our scientific questions and approach. All participants included in analyses completed all treatments, the various arms for the study vary only in the order in which participants received each treatment. These data show the change in suicidality from baseline to treatment 6 based on the Scale of Suicide Ideation.

The measure completed was the Scale of Suicide Ideation. For this study, participants completed the following questions of the questionnaire:

  1. wish to live (0 Moderate to Strong, 1 Weak, 2 None)
  2. wish to die (0 None, 1 Weak, 2 Moderate to Strong)

The total scores range from 0-4. Lower scores indicate high suicide ideation, and high scores indicate low suicide ideation.

Time Frame assessed at baseline on treatment days 1-6.
Hide Outcome Measure Data
Hide Analysis Population Description
114 Assessments of suicidality were completed across 13 participants on days 1-6. Data reported show the average change in suicidality from baseline to treatment 6 based on the Scale of Suicide Ideation.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants enrolled in study procedures
Overall Number of Participants Analyzed 13
Overall Number of Units Analyzed
Type of Units Analyzed: Suicide Assessments
114
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change in Will to live 0.077  (0.277)
Change in Will to die 0.077  (0.277)
5.Secondary Outcome
Title ECT Seizure Duration
Hide Description Duration (in seconds) of seizure induced by ECT treatment
Time Frame up to days 1-6
Hide Outcome Measure Data
Hide Analysis Population Description
These data were not collected from patient ECT procedure records and therefore were not analyzed.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants enrolled in study procedures.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title ECT Electrical Dose
Hide Description

The electrical dose necessary for seizure induction is determined during a dose-charge titration session prior to participant randomization and session 1. These results report the average electrical dose across all participants for the first treatment session during Treatment Week 1.

The range for these data is 0 - 100% electrical charge.

Time Frame First ECT treatment session during Treatment Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Results are shown for all 13 participants who completed at least one treatment session following the dose charge titration session.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants enrolled in study procedures.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: percentage of electrical charge
32.5  (8.66)
7.Secondary Outcome
Title Subjective Assessment of Whether ECT Was Performed, Determined by Asking the Patient.
Hide Description

To assess patient blinding of treatment performed, the patient will be asked: "Based on how you feel, did you have ECT today?"

Results indicate participants correctly answering the subjective assessment.

Time Frame Assessed at 120 minutes after return of responsiveness on treatment days 1-6
Hide Outcome Measure Data
Hide Analysis Population Description
The sample analyzed for each group consists of the total number of treatments performed with paired subjective assessments out of 12 participants.
Arm/Group Title Etomidate + ECT Ketamine + ECT Ketamine Alone
Hide Arm/Group Description:

General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Overall Number of Participants Analyzed 12 12 12
Overall Number of Units Analyzed
Type of Units Analyzed: Subjective Assessments w/ paired Tx
23 21 22
Count of Units
Unit of Measure: Subjective Assessments w/ paired Tx
18
  78.3%
18
  85.7%
6
  27.3%
8.Secondary Outcome
Title Change in Mood Assessed Using the Mood Self-Assessment Manikin
Hide Description

Mood Self-Assessment Manikin (SAM) Scale: 1 (very unpleasant) - 9 (very pleasant).

The groups/arms for this outcome are combined as a whole-group analysis due to the Crossover design of this study, as pre-specified by the study protocol. Breaking up the analyses into the various arms of the study would change our scientific questions and approach. Further, any statistical analyses would be underpowered due to low participant numbers in each arm. Thus, the results are combined and reported as a whole group analysis. All participants included in analyses completed all treatments included in the study, the various arms for the study vary only in the order in which participants received each treatment. These data show the change in mood from baseline to treatment 6 based on the SAM. Additionally, data collected at baseline are not dependent on the study group/arm.

Time Frame baseline and 120 minutes after return of responsiveness, assessed on treatment days 1-6
Hide Outcome Measure Data
Hide Analysis Population Description
The average change in SAM score from baseline to t=120 for all sessions across all participants (t=120 - baseline).
Arm/Group Title AllParticipants
Hide Arm/Group Description:
All participants enrolled in study procedures.
Overall Number of Participants Analyzed 13
Overall Number of Units Analyzed
Type of Units Analyzed: SAM Assessments
64
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.266  (1.043)
9.Secondary Outcome
Title Average Change in Mood Based on the Depression PROMIS-CAT
Hide Description

PROMIS-CAT (Patient Reported Outcomes Measurement Information System-Computer Adaptive Testing) for depression

The groups/arms for this outcome are combined as a whole-group analysis due to the Crossover design of this study, as pre-specified by the study protocol. Breaking up the analyses into the various arms of the study would change our scientific questions and approach. Further, any statistical analyses would be underpowered due to low participant numbers in each arm. Thus, the results are combined and reported as a whole group analysis. All participants included in analyses completed all treatments included in the study, the various arms for the study vary only in the order in which participants received each treatment. These data show the change in mood from baseline to treatment 6 based on the PROMIS-CAT. Additionally, data collected at baseline are not dependent on the study group/arm.

Time Frame baseline and 120 minutes after return of responsiveness, assessed on treatment days 1-6
Hide Outcome Measure Data
Hide Analysis Population Description
All 13 participants who completed the depression PROMS-CAT both before and after treatment (baseline and 120 minutes following return of responsiveness) on at least one treatment day.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants enrolled in study procedures.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.5108  (1.975)
10.Secondary Outcome
Title Change in Delta Band (0.5-4 Hz) Relative Power in the Scale EEG During Recovery
Hide Description High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Results are reported as the percent of total power in the delta band over the sum of total power between 0.5 - 70Hz.
Time Frame baseline, post-ECT from 0-120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with EEG data collected at baseline at T0 post-ECT for at least 1 ECT session were included in analyses.
Arm/Group Title Etomidate + ECT Ketamine + ECT Ketamine Alone
Hide Arm/Group Description:

General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Overall Number of Participants Analyzed 9 9 10
Median (Inter-Quartile Range)
Unit of Measure: percent of total power
-0.064
(-0.182 to 0.033)
-0.111
(-0.160 to 0.00)
-0.038
(-0.106 to 0.118)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT
Comments Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.301
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT
Comments Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.301
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ketamine Alone
Comments Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.557
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
11.Secondary Outcome
Title Change in Theta Band (4-8 Hz) Relative Power in the Scalp EEG During Recovery
Hide Description High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Results are reported as the percent of total power in the theta band over the sum of total power between 0.5 - 70Hz.
Time Frame baseline, post-ECT from 0-120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with EEG data collected at baseline at T0 post-ECT for at least 1 ECT session were included in analyses.
Arm/Group Title Etomidate + ECT Ketamine + ECT Ketamine Alone
Hide Arm/Group Description:

General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Overall Number of Participants Analyzed 9 9 10
Median (Inter-Quartile Range)
Unit of Measure: percent of total power
-0.008
(-0.048 to 0.051)
-0.015
(-0.038 to 0.077)
0.015
(-0.040 to 0.156)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT
Comments Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.910
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT
Comments Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.734
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ketamine Alone
Comments Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.322
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
12.Secondary Outcome
Title Change in Alpha Band (8-13 Hz) Power in the Scalp EEG During Recovery
Hide Description High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Results are reported as the percent of total power in the alpha band over the sum of total power between 0.5 - 70Hz.
Time Frame baseline, post-ECT from 0-120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with EEG data collected at baseline at T0 post-ECT for at least 1 ECT session were included in analyses.
Arm/Group Title Etomidate + ECT Ketamine + ECT Ketamine Alone
Hide Arm/Group Description:

General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Overall Number of Participants Analyzed 9 9 10
Median (Inter-Quartile Range)
Unit of Measure: percent of total power
0.016
(-0.001 to 0.142)
0.053
(0.016 to 0.112)
0.006
(-0.026 to 0.053)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT
Comments Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT
Comments Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ketamine Alone
Comments Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.375
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
13.Secondary Outcome
Title Change in Beta Band (13-20 Hz) Relative Power in the Scalp EEG During Recovery
Hide Description High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Results are reported as the percent of total power in the beta band over the sum of total power between 0.5 - 70Hz.
Time Frame baseline, post-ECT from 0-120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with EEG data collected at baseline at T0 post-ECT for at least 1 ECT session were included in analyses.
Arm/Group Title Etomidate + ECT Ketamine + ECT Ketamine Alone
Hide Arm/Group Description:

General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Overall Number of Participants Analyzed 9 9 10
Median (Inter-Quartile Range)
Unit of Measure: percent of total power
-0.001
(-0.010 to 0.029)
-0.004
(-0.012 to 0.039)
-0.008
(-0.019 to 0.014)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT
Comments Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.910
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT
Comments Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.910
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ketamine Alone
Comments Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.625
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
14.Secondary Outcome
Title Change in Anterior-Posterior Functional Connectivity in the Scalp During Recovery
Hide Description

High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Results are reported as the coherence measure, which is used for tracking changes in anterior-posterior functional connectivity.

Coherence is a measure of synchronization between two signals which is used to measure anterior-posterior functional connectivity. Coherence is a unitless measure between 0 and 1. High coherence between time-series of two neural populations reflects higher efficiency in communication between those populations and therefore stronger functional connectivity.

Time Frame baseline, post-ECT from 0-120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with EEG data collected at baseline at T0 post-ECT for at least 1 ECT session were included in analyses.
Arm/Group Title Etomidate + ECT Ketamine + ECT Ketamine Alone
Hide Arm/Group Description:

General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Overall Number of Participants Analyzed 9 9 10
Median (Inter-Quartile Range)
Unit of Measure: unitless
-0.014
(-0.052 to 0.004)
-0.002
(-0.010 to 0.014)
-0.004
(-0.043 to 0.0023)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT
Comments Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT
Comments Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.910
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ketamine Alone
Comments Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.625
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
15.Secondary Outcome
Title Change in Anterior-Posterior Phase-lag in the Scalp EEG During Recovery
Hide Description High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Phase-lag was assessed using the Phase-Lag Index (PLI), a measure ranging from 0 - 1. A consistent phase-lag between two tim-series results in a PLI of 1. A time-series without coupling results in a PLI near or equaling 0. Results show the difference in anterior-posterior PLI between baseline and post-ECT.
Time Frame baseline, post-ECT from 0 -120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etomidate + ECT Ketamine + ECT Ketamine Alone
Hide Arm/Group Description:

General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Overall Number of Participants Analyzed 9 9 10
Median (Inter-Quartile Range)
Unit of Measure: Phase Lag Index (PLI)
-0.001
(-0.034 to 0.044)
-0.049
(-0.089 to 0.066)
-0.017
(-0.058 to -0.005)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT
Comments Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT
Comments Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.496
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ketamine Alone
Comments Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments [Not Specified]
Method Wilcoxon signed-rank paired test
Comments [Not Specified]
16.Secondary Outcome
Title Change in EEG Entropy in the Scalp EEG During Recovery
Hide Description

High-density EEG collected during 5-minute epochs of eyes-closed quiet resting at baseline and post-ECT. Results are reported as permutation entropy (PE) measures in posterior regions, which we are using to track changes in scalp EEG entropy.

Permutation Entropy (PE) is a measure that is used to quantify the complexity of time series signals. It is a unitless measure between 0 and 1. Lower the PE represents a more regular and more deterministic time series while higher PE represents a more complex time series.

Time Frame baseline, Post-ECT from 0 -120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with EEG data collected at baseline at T0 post-ECT for at least 1 ECT session were included in analyses.
Arm/Group Title Etomidate + ECT Ketamine + ECT Ketamine Alone
Hide Arm/Group Description:

General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Electroconvulsive Therapy: Dose of the ECT charge will be determined during titration session prior to randomization.

General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.

Ketamine: Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.

Overall Number of Participants Analyzed 9 9 10
Median (Inter-Quartile Range)
Unit of Measure: unitless
-0.018
(-0.047 to -0.005)
-0.003
(-0.039 to 0.013)
-0.006
(-0.012 to 0.003)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etomidate + ECT
Comments Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ketamine + ECT
Comments Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.359
Comments [Not Specified]
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ketamine Alone
Comments Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.375
Comments [Not Specified]
Method Wilcoxon Signed-Ranked Test
Comments [Not Specified]
Time Frame approximately 3 weeks
Adverse Event Reporting Description

Each group/arm of this crossover study were reported separately. All participants who completed at least 1 treatment session were included in adverse event reporting.

Each group contains a total of 15 participants, as each participant completed each arm of the study at least once.

 
Arm/Group Title Ketamine +ECT Etomidate +ECT Ketamine Sham
Hide Arm/Group Description General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose. General anesthesia for ECT will be induced with etomidate, approximately 0.2 mg/kg (0.1-0.6 mg/kg). Following application of stimulation electrodes to the patients scalp, an ECT charge will be administered at the previously determined therapeutic dose. General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.
All-Cause Mortality
Ketamine +ECT Etomidate +ECT Ketamine Sham
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Hide Serious Adverse Events
Ketamine +ECT Etomidate +ECT Ketamine Sham
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine +ECT Etomidate +ECT Ketamine Sham
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alyssa Labonte
Organization: Washington Universtiy School of Medicine
Phone: 314-273-7338
EMail: alabonte@wustl.edu
Layout table for additonal information
Responsible Party: Ben Palanca, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02761330    
Other Study ID Numbers: 201512110
First Submitted: April 30, 2016
First Posted: May 4, 2016
Results First Submitted: September 11, 2020
Results First Posted: June 28, 2021
Last Update Posted: June 28, 2021