Clinical trial NCT05465915: Pulse Width 0.15ms vs 0.30ms in Electroconvulsive Therapy
Official title: The Effect of 0.15ms Pulse Width on the Outcome of Electroconvulsive Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Major Depressive Disorder
Bipolar Depression
Keywords: Electroconvulsive Therapy, Depression, Pulse-Width
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects are randomized into two groups (blue and red) where crossover titration of ECT is used. From the 3. application and onwards, subjects continue either with 0.15ms or 0.30ms pulse width.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Recovery (TTR)
timeFrame: immediately after each ECT procedure, measured in minutes.
measure: ECCA (Electroconvulsive cognitive assesment)
timeFrame: 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
measure: AMI (Autobiographical Memory Interview)
timeFrame: 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
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: 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
measure: QIDS (The Quick Inventory of Depressive Symptomatology)
timeFrame: 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
measure: MADRS (Montgomery-Asberg Depression Rating Scale)
timeFrame: 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
measure: BVMT-R (Brief Visuospatial Memory Test-Revised)
timeFrame: 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
measure: RAVLT (The Rey Auditory Verbal Learning Test)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
state: Czech Republic
Study officials:
affiliation: Department of Psychiatry, First Faculty of Medicine, Charles University
name: Jana Heidingerová
role: PRINCIPAL_INVESTIGATOR
References: