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

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.

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.

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.

Blocked randomization is used to divide patients into blue and red group via an allocator. ECT practitioners are aware which patient belongs to which group but are blinded to block size. Testers, patients and attending psychiatrists are blinded to what group the patients belong to and what ECT parameters are used.

Session - Titration with 0.30ms pulse width Session - Titration with 0.15ms pulse width Session and further - continue with 0.15ms pulse width

Session - Titration with 0.15ms pulse width Session - Titration with 0.3ms pulse width Session and further - continue with 0.3ms pulse width

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

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

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

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

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

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

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

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