Pulse Width 0.15ms vs 0.30ms in Electroconvulsive Therapy (PWECT015)

The Effect of 0.15ms Pulse Width on the Outcome of Electroconvulsive Therapy

The PWECT015 study was designed to compare the application of 0.15ms and 0.30ms pulse width in electroconvulsive therapy (ECT). Subjects will be compared both within groups and in-group via psychometric scales.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Depression; Major Depressive Disorder
• Intervention / Treatment: Device: Electroconvulsive therapy

Detailed Description

This study is a controlled randomized clinical trial. Patients (projected n=40 are randomized into two groups - blue (20) and red (20). Randomization will be blocked (size sample 4) - 1 allocator. ECT practitioners are aware which patient belongs to which group but are blinded to block size. Testers are blinded to what group the patients belong to and what ECT parameters are used. Patients and attending psychiatrists are also blinded as to which group the patient belongs to.

The MECTA SIGMA device will be used for ECT.

Cross-over titration by stimulation will be used during the application of ECT to find the seizure threshold (ST) as follows:

RED GROUP

1. Session - Titration with 0.15ms
2. Session - Titration with 0.3 ms
3. Session and further - continue with 0.3 ms pulse width and 6x ST found during the second session.

BLUE GROUP

1. Session - Titration with 0.30ms
2. Session - Titration with 0.15ms
3. Session and further - continue with 0.15ms pulse width and 6x ST found during the second session.

Delivered energy is measured in percentage (%) of the maximum charge (in millicoulombs, mC) that the European version of the MECTA SIGMA device is able to administer. Total amount of ECT applications is individual and based on the clinical state of the patient. ECT outcome will be predicted via seizure duration (SD). If the seizure duration is less than 15s, the ECT dosage will be increased during next session by 100%. Throughout the ECT course, patients will be closely monitored by the testers via psychometric scales.

Primary outcome of the study is measured via Time To Recovery (TTR) - which is measured after each ECT application. TTR is the time (in minutes) after which the patient is fully vigilant and aware of his surroundings after an ECT procedure. TTR will be compared both in-group and between groups. Other psychometric measures are specified in the outcome measures section.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jozef Buday; Phone Number: 00420731494884; Email: jozef.buday@vfn.cz

Study Locations

• Czechia
  • Czech Republic
    • Prague, Czech Republic, Czechia, 12000
      • Recruiting
      • Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
      • Contact: Jozef Buday; Phone Number: 00420731494884; Email: jozef.buday@vfn.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age equal to 18 or higher
• score equal or higher than 20 on the Montgomery-Asberg Depression Scale (MADRS),
• major depressive disorder or bipolar depression

Exclusion Criteria:

• other axis 1 disorder
• ECT in the last 3 months
• neurological disease
• psychosis
• pregnancy
• any somatic condition that contraindicates ECT

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Blue; Session - Titration with 0.30ms pulse width; Session - Titration with 0.15ms pulse width; Session and further - continue with 0.15ms pulse width	Device: Electroconvulsive therapy; Patients are treated with ECT.
Active Comparator: Red; Session - Titration with 0.15ms pulse width; Session - Titration with 0.3ms pulse width; Session and further - continue with 0.3ms pulse width	Device: Electroconvulsive therapy; Patients are treated with ECT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Recovery (TTR)	time to when the patient is fully vigilant and aware of his surroundings after an ECT procedure	immediately after each ECT procedure, measured in minutes.
ECCA (Electroconvulsive cognitive assesment)	cognitive screening optimized for measuring cognitive functions in patients before, during and after the course of ECT.	T1: baseline, 2 days before the commencement of an ECT course, T2: during the course of ECT, between second and third ECT application, T3: after the course of ECT, within 2 days
AMI (Autobiographical Memory Interview)	This interview is intended to quantify retrograde amnesia following electroconvulsive therapy (ECT).	T1: baseline, 2 days before the commencement of an ECT course, T2: after the course of ECT, within 2 days , T3: 2 months after the ECT course , T4: 4 months after the ECT course, T5: 6 months after the ECT course
MoCA (Montreal Cognitive Assessment)	Screening of cognitive functions, results used as an inclusion criteria of the study and for the determination of the cognitive baseline.	T1: baseline, 2 days before the commencement of an ECT course, T2: 2 months after the ECT course, T3: 4 months after the ECT course, T4: 6 months after the ECT course
QIDS (The Quick Inventory of Depressive Symptomatology)	Rates depression symptoms via self-assessment	T1: baseline, 2 days before the commencement of an ECT course, T2: during the course of ECT, between second and third ECT application, T3: after the course of ECT, within 2 days, T4: 2 months after ECT , T5: 4 months after ECT, T6: 6 months after ECT
MADRS (Montgomery-Asberg Depression Rating Scale)	Assessment of depression severity, objective scale based on clinicians interview with a patient, results also used as an inclusion criteria of the study.	T1: baseline, 2 days before the commencement of an ECT course, T2: during the course of ECT, between second and third ECT application, T3: after the course of ECT, within 2 days, T4: 2 months after ECT , T5: 4 months after ECT, T6: 6 months after ECT
BVMT-R (Brief Visuospatial Memory Test-Revised)	Neuropsychological assessment designed to evaluate visuospatial memory in patients.	1: baseline, 2 days before the commencement of an ECT course, T2: after the course of ECT, within 2 days , T3: 2 months after the ECT course , T4: 4 months after the ECT course, T5: 6 months after the ECT course
RAVLT (The Rey Auditory Verbal Learning Test)	Neuropsychological assessment designed to evaluate verbal memory in patients.	1: baseline, 2 days before the commencement of an ECT course, T2: after the course of ECT, within 2 days , T3: 2 months after the ECT course , T4: 4 months after the ECT course, T5: 6 months after the ECT course

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Principal Investigator: Jana Heidingerová, Department of Psychiatry, First Faculty of Medicine, Charles University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Anticipated): July 18, 2023
• Study Completion (Anticipated): January 18, 2024

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Electroconvulsive Therapy, Depression, Pulse-Width
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Bipolar Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 1885/20 S-IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD can be shared upon request from a verified researcher.
• IPD Sharing Time Frame: Data will be available after the end of study, indefinitely
• IPD Sharing Access Criteria: upon individual request by a verified researcher
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes