Pulse Width 0.15ms vs 0.30ms in Electroconvulsive Therapy

Major Depressive Disorder Clinical Trial

— PWECT015  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05465915
• Other study ID #: 1885/20 S-IV
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 18, 2022
• Est. completion date: January 18, 2024

Study information

• Verified date: July 2022
• Source: Charles University, Czech Republic
• Contact: Jozef Buday
• Phone: 00420731494884
• Email: jozef.buday[@]vfn.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 18, 2024
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Electroconvulsive therapy
Patients are treated with ECT.

Locations

Country	Name	City	State
Czechia	Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague	Prague	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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