Pulse Width 0.15ms vs 0.30ms in Electroconvulsive Therapy

NCT05465915 | Unknown Early Phase 1 FDA Device

• 1 other identifier: 1885/20 S-IV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Bipolar Depression

Keywords

Electroconvulsive Therapy, Depression, Pulse-Width

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Blue

ACTIVE COMPARATOR

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

Device: Electroconvulsive therapy

Red

ACTIVE COMPARATOR

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

Device: Electroconvulsive therapy

Interventions

Electroconvulsive therapy DEVICE

Patients are treated with ECT.

Blue; Red

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• other axis 1 disorder
• ECT in the last 3 months
• neurological disease
• psychosis
• pregnancy
• any somatic condition that contraindicates ECT

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague

Prague, Czech Republic, 12000, Czechia

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jana Heidingerová

  Department of Psychiatry, First Faculty of Medicine, Charles University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jozef Buday

CONTACT

00420731494884; jozef.buday@vfn.cz

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurostimulation Center, General University Hospital in Prague

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: July 20, 2022
• Study Start: January 18, 2022
• Primary Completion: July 18, 2023
• Study Completion: January 18, 2024
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after the end of study, indefinitely
• Access Criteria: upon individual request by a verified researcher

Locations

CZ (1)