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

Charles University, Czech Republic

Status and phase: Enrolling; Early Phase 1

Conditions: Major Depressive Disorder; Bipolar Depression

Treatments: Device: Electroconvulsive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05465915

1885/20 S-IV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Blue

Active Comparator group

Description:

1. Session - Titration with 0.30ms pulse width 2. Session - Titration with 0.15ms pulse width 3. Session and further - continue with 0.15ms pulse width

Treatment:

Device: Electroconvulsive therapy

Red

Active Comparator group

Description:

1. Session - Titration with 0.15ms pulse width 2. Session - Titration with 0.3ms pulse width 3. Session and further - continue with 0.3ms pulse width

Treatment:

Device: Electroconvulsive therapy