Pulse Width 0.15ms vs 0.30ms in Electroconvulsive Therapy

Study Overview
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Brief Summary
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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
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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 Session - Titration with 0.15ms Session - Titration with 0.3 ms Session and further - continue with 0.3 ms pulse width and 6x ST found during the second session. BLUE GROUP Session - Titration with 0.30ms Session - Titration with 0.15ms 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.

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

Conditions
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Major Depressive Disorder, Bipolar Depression

Intervention / Treatment
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* Device: Electroconvulsive therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blue<br>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<br>* Patients are treated with ECT.<br>|
| Active Comparator: Red<br>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<br>* Patients are treated with ECT.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroconvulsive Therapy, Depression, Pulse-Width