Major Depressive DisorderEarly Phase 1PWECT015NCT05465915
Pulse Width 0.15ms vs 0.30ms in Electroconvulsive Therapy
A Early Phase 1 study testing Electroconvulsive therapy in people with Major Depressive Disorder and Bipolar Depression, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Bipolar Depression
- What is being tested?
- Electroconvulsive therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 18 Jan 2022to 18 Jan 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- other axis 1 disorder
- ECT in the last 3 months
- neurological disease
- psychosis
- pregnancy
- any somatic condition that contraindicates ECT
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Psychiatric Department, General University Hospital and 1st Faculty of Medicine, Prague
Prague, Czech Republic, 12000
Jozef Buday, 00420731494884, jozef.buday@vfn.cz
About this study
Official title: The Effect of 0.15ms Pulse Width on the Outcome of Electroconvulsive Therapy
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.
Read the 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
- 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.
- Conditions
- Major Depressive Disorder, Bipolar Depression
- Being tested
- Electroconvulsive therapy
- Keywords
- Electroconvulsive Therapy, Depression, Pulse-Width
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive therapyDevice
Patients are treated with ECT.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Electroconvulsive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recovery (TTR)
time to when the patient is fully vigilant and aware of his surroundings after an ECT procedure
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start18 Jan 2022
- Primary completion18 Jul 2023 (estimated)
- Study completion18 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jozef Buday, Charles University, Czech Republic
- Investigators
- Jana Heidingerová, Principal investigator, Department of Psychiatry, First Faculty of Medicine, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465915
- Sponsor's protocol ID
- 1885/20 S-IV
- Acronym
- PWECT015
- Status last verified
- Jul 2022
- First submitted
- 18 Jan 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD can be shared upon request from a verified researcher.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 0.15ms Pulse Width on the Outcome of Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT05465915
- Acronym / sponsor ID
- PWECT015 / 1885/20 S-IV
- Conditions
- Major Depressive Disorder, Bipolar Depression
- Keywords
- Electroconvulsive Therapy, Depression, Pulse-Width
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 18 Jul 2023 (estimated)
- Study completion
- 18 Jan 2024 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Blue | Active comparator | Device: Electroconvulsive therapy1. 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 |
| Red | Active comparator | Device: Electroconvulsive therapy1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- other axis 1 disorder
- ECT in the last 3 months
- neurological disease
- psychosis
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive therapyPatients are treated with ECT. | Device | Blue, Red |
Primary outcome
Time to Recovery (TTR)
Time frame: immediately after each ECT procedure, measured in minutes.
time to when the patient is fully vigilant and aware of his surroundings after an ECT procedure
ECCA (Electroconvulsive cognitive assesment)
Time frame: 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
cognitive screening optimized for measuring cognitive functions in patients before, during and after the course of ECT.
AMI (Autobiographical Memory Interview)
Time frame: 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
This interview is intended to quantify retrograde amnesia following electroconvulsive therapy (ECT).
MoCA (Montreal Cognitive Assessment)
Time frame: 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
Screening of cognitive functions, results used as an inclusion criteria of the study and for the determination of the cognitive baseline.
QIDS (The Quick Inventory of Depressive Symptomatology)
Time frame: 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
Rates depression symptoms via self-assessment
MADRS (Montgomery-Asberg Depression Rating Scale)
Time frame: 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.
BVMT-R (Brief Visuospatial Memory Test-Revised)
Time frame: 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
Neuropsychological assessment designed to evaluate visuospatial memory in patients.
RAVLT (The Rey Auditory Verbal Learning Test)
Time frame: 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
Neuropsychological assessment designed to evaluate verbal memory in patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Yes. IPD can be shared upon request from a verified researcher.
Related trials for Major Depressive Disorder
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Not yet recruiting
Acceptance and Committment Therapy Combined With Ketamine in Difficult-to-Treat Depression.
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jana Heidingerová principal investigator
Department of Psychiatry, First Faculty of Medicine, Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Electroconvulsive therapy in people with Major Depressive Disorder and Bipolar Depression, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jozef Buday (00420731494884, jozef.buday@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Recovery (TTR) (time frame: immediately after each ECT procedure, measured in minutes.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.