ECTNCT04451135
CET- REM (Correlating ECT Response to EEG Markers)
A study testing Electroencephalographic (EEG), Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) and Ictal Electroencephalographic (EEG) Measurements in people with ECT and Treatment Resistant Depression, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Single-center study to determine the relationship between changes in depression symptoms and electroencephalographic (EEG) patterns induced by electroconvulsive therapy (ECT) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ECT, Treatment Resistant Depression
- What is being tested?
- Electroencephalographic (EEG), Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) and Ictal Electroencephalographic (EEG) Measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2020to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years or greater
- Referral for ECT index course for treatment-resistant depression (unipolar major depressive disorder or bipolar depression), major depressive disorder with psychotic symptoms, schizophrenia or schizoaffective being treated for a depressed episode, unspecified depression
Who cannot join
- Schizophrenia or schizoaffective disorder not being treated for a depressed episode.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: Correlating Electroconvulsive Therapy Response to Electroencephalographic Ictal Complexes and Postictal Markers
Single-center study to determine the relationship between changes in depression symptoms and electroencephalographic (EEG) patterns induced by electroconvulsive therapy (ECT)
Read the detailed description
Electroconvulsive therapy (ECT) is an effective treatment for many psychiatric illnesses, including major depressive disorder. While effective, objective markers have not been developed to predict clinical outcome trajectories following ECT. This is important given the risks and costs incurred during a full treatment course. Electroencephalography (EEG) is typically employed to monitor the generation and termination of ECT-induced seizures but leverage of markers toward prognostication remains a future goal. The investigators have characterized two distinct EEG patterns associated with ECT-induced generalized seizures and have two sleep markers that may serve as markers for predicting response to treatment. Central Positive Complexes (CPCs) are large ictal complexes with a scalp topology of voltage declining from the top of the head. CPCs are localized to cortical areas that are involved in the formation of sleep spindles and slow wave sleep. A pattern of low-voltage activity, known as post-ictal generalized electroencephalographic suppression (PGES), is frequently used to document termination of these seizures. Additionally, two EEG markers of sleep microstructure may have utility given their association with synaptic plasticity, a process presumably invoked over the course of ECT-induced recovery from psychiatric illness as pathologic neural circuitry undergoes reconfiguration. These two markers, sleep spindles and slow waves show altered expression patterns in patients with psychiatric disorders, and thus may be useful as objective markers of ECT responsiveness. None of the above EEG markers have been explored for an association to interval changes in disease severity over the course of ECT. This project will incisively probe the relationships between temporal trajectories of major depressive disorder severity and longitudinal measurements of ictal and postictal EEG markers.
- Conditions
- ECT, Treatment Resistant Depression
- Being tested
- Electroencephalographic (EEG), Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16), Ictal Electroencephalographic (EEG) Measurements, Post-Ictal Electroencephalographic (EEG) Suppression Measurements
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalographic (EEG)Diagnostic test
EEG on nights after ECT session will be recorded using the DREEM device. Sleep EEG data will also be acquired for a minimum of one night prior to the first ECT session, providing a true baseline measure. The DREEM device allows continuous recording of multichannel EEG
Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16)Diagnostic test
The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) is a measure of depression symptom severity that has been validated for clinical and research use53. It is a standard self-report measurement completed by patients prior to each ECT session
Ictal Electroencephalographic (EEG) MeasurementsDiagnostic test
A high-density 65-electrode EEG scalp electrode net (EGI/Philips) with Elefix conductive gel injected within Ag/AgCl electrode sensors is utilized to monitor brain activity during the ictal period
Post-Ictal Electroencephalographic (EEG) Suppression MeasurementsDiagnostic test
A board-certified epileptologist will review all seizures to assess seizure parameters, including duration of seizure and interval of PGES. Preprocessing of the PGES periods will be accomplished with band-pass filtering from 2 to 30 Hz with 1st order Butterworth filters.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Treatment-Resistant Depression | Experimental | Not described Receives: Diagnostic Test: Electroencephalographic (EEG); Diagnostic Test: Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16); Diagnostic Test: Ictal Electroencephalographic (EEG) Measurements; Diagnostic Test: Post-Ictal Electroencephalographic (EEG) Suppression Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interval change in Quick Inventory of Depressive Symptomatology-16 Item Self Report (QIDS-SR16) between ECT sessions.
16 item Self-report questionnaire that best describes the participant's depressive symptoms over the last seven days. Scale: 0=never or do not, 3=nearly all the time, or the highest level of time listed on the question.
Measured: Up to 8 weeks during patients ECT treatment course
Duration of Central Positive Complexes during ECT treatments.
Total time (in seconds) during the ictal period for which CPCs are present in the EEG immediately following seizure induction until termination of the seizure.
Range of values: 0 - 300 seconds
Measured: Up to 8 weeks during patients ECT treatment course
Duration of PGES during ECT treatments.
Total time (in seconds) during the postictal period for which PGES is present in the EEG immediately following seizure termination for up to 5 minutes.
Range of values: 0 - 300 seconds
Measured: Up to 8 weeks during patients ECT treatment course
Density of EEG sleep spindles during non-rapid eye movement (NREM) stages N2 on evenings following ECT treatments.
The total number of EEG sleep spindles per minute present during N2 sleep. Range of values: 0 - 60 spindles/min
Measured: Up to 8 weeks during patients ECT treatment course
Slow wave activity (SWA) during N3 sleep on evenings following ECT treatments
Total power of EEG slow waves per minute present during the first identified cycle of N3 sleep Range of values: 0 - 50 dB/min
Measured: Up to 8 weeks during patients ECT treatment course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start9 Oct 2020
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ECTStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MohammadMehdi Kafashan, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451135
- Sponsor's protocol ID
- 202006108
- Status last verified
- Dec 2025
- First submitted
- 24 Jun 2020
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopez J, Hoffmann R, Armitage R. Reduced sleep spindle activity in early-onset and elevated risk for depression. J Am Acad Child Adolesc Psychiatry. 2010 Sep;49(9):934-43. doi: 10.1016/j.jaac.2010.05.014. Epub 2010 Jul 24.
PubMed 20732629Kho KH, van Vreeswijk MF, Simpson S, Zwinderman AH. A meta-analysis of electroconvulsive therapy efficacy in depression. J ECT. 2003 Sep;19(3):139-47. doi: 10.1097/00124509-200309000-00005.
PubMed 12972983Kafashan M, Brian Hickman L, Labonte AK, Huels ER, Maybrier H, Guay CS, Subramanian S, Farber NB, Ching S, Hogan RE, Kelz MB, Avidan MS, Mashour GA, Palanca BJA. Quiescence during burst suppression and postictal generalized EEG suppression are distinct patterns of activity. Clin Neurophysiol. 2022 Oct;142:125-132. doi: 10.1016/j.clinph.2022.07.493. Epub 2022 Jul 30.
PubMed 36030576
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlating Electroconvulsive Therapy Response to Electroencephalographic Ictal Complexes and Postictal Markers
- ClinicalTrials.gov ID
- NCT04451135
- Acronym / sponsor ID
- 202006108
- Conditions
- ECT, Treatment Resistant Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Jun 2020 (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.
Single-center study to determine the relationship between changes in depression symptoms and electroencephalographic (EEG) patterns induced by electroconvulsive therapy (ECT)
Detailed description
Electroconvulsive therapy (ECT) is an effective treatment for many psychiatric illnesses, including major depressive disorder. While effective, objective markers have not been developed to predict clinical outcome trajectories following ECT. This is important given the risks and costs incurred during a full treatment course. Electroencephalography (EEG) is typically employed to monitor the generation and termination of ECT-induced seizures but leverage of markers toward prognostication remains a future goal. The investigators have characterized two distinct EEG patterns associated with ECT-induced generalized seizures and have two sleep markers that may serve as markers for predicting response to treatment. Central Positive Complexes (CPCs) are large ictal complexes with a scalp topology of voltage declining from the top of the head. CPCs are localized to cortical areas that are involved in the formation of sleep spindles and slow wave sleep. A pattern of low-voltage activity, known as post-ictal generalized electroencephalographic suppression (PGES), is frequently used to document termination of these seizures. Additionally, two EEG markers of sleep microstructure may have utility given their association with synaptic plasticity, a process presumably invoked over the course of ECT-induced recovery from psychiatric illness as pathologic neural circuitry undergoes reconfiguration. These two markers, sleep spindles and slow waves show altered expression patterns in patients with psychiatric disorders, and thus may be useful as objective markers of ECT responsiveness. None of the above EEG markers have been explored for an association to interval changes in disease severity over the course of ECT. This project will incisively probe the relationships between temporal trajectories of major depressive disorder severity and longitudinal measurements of ictal and postictal EEG markers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Treatment-Resistant Depression | Experimental | Diagnostic Test: Electroencephalographic (EEG), Diagnostic Test: Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16), Diagnostic Test: Ictal Electroencephalographic (EEG) Measurements, Diagnostic Test: Post-Ictal Electroencephalographic (EEG) Suppression Measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or greater
- Referral for ECT index course for treatment-resistant depression (unipolar major depressive disorder or bipolar depression), major depressive disorder with psychotic symptoms, schizophrenia or schizoaffective being treated for a depressed episode, unspecified depression
Key exclusion criteria (1 listed)
- Schizophrenia or schizoaffective disorder not being treated for a depressed episode.
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 |
|---|---|---|
| Electroencephalographic (EEG)EEG on nights after ECT session will be recorded using the DREEM device. Sleep EEG data will also be acquired for a minimum of one night prior to the first ECT session, providing a true baseline measure. The DREEM device allows continuous recording of multichannel EEG | Diagnostic test | Patients with Treatment-Resistant Depression |
| Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16)The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) is a measure of depression symptom severity that has been validated for clinical and research use53. It is a standard self-report measurement completed by patients prior to each ECT session | Diagnostic test | Patients with Treatment-Resistant Depression |
| Ictal Electroencephalographic (EEG) MeasurementsA high-density 65-electrode EEG scalp electrode net (EGI/Philips) with Elefix conductive gel injected within Ag/AgCl electrode sensors is utilized to monitor brain activity during the ictal period | Diagnostic test | Patients with Treatment-Resistant Depression |
| Post-Ictal Electroencephalographic (EEG) Suppression MeasurementsA board-certified epileptologist will review all seizures to assess seizure parameters, including duration of seizure and interval of PGES. Preprocessing of the PGES periods will be accomplished with band-pass filtering from 2 to 30 Hz with 1st order Butterworth filters. | Diagnostic test | Patients with Treatment-Resistant Depression |
Primary outcome
Interval change in Quick Inventory of Depressive Symptomatology-16 Item Self Report (QIDS-SR16) between ECT sessions.
Time frame: Up to 8 weeks during patients ECT treatment course
16 item Self-report questionnaire that best describes the participant's depressive symptoms over the last seven days. Scale: 0=never or do not, 3=nearly all the time, or the highest level of time listed on the question.
Duration of Central Positive Complexes during ECT treatments.
Time frame: Up to 8 weeks during patients ECT treatment course
Total time (in seconds) during the ictal period for which CPCs are present in the EEG immediately following seizure induction until termination of the seizure. Range of values: 0 - 300 seconds
Duration of PGES during ECT treatments.
Time frame: Up to 8 weeks during patients ECT treatment course
Total time (in seconds) during the postictal period for which PGES is present in the EEG immediately following seizure termination for up to 5 minutes. Range of values: 0 - 300 seconds
Density of EEG sleep spindles during non-rapid eye movement (NREM) stages N2 on evenings following ECT treatments.
Time frame: Up to 8 weeks during patients ECT treatment course
The total number of EEG sleep spindles per minute present during N2 sleep. Range of values: 0 - 60 spindles/min
Slow wave activity (SWA) during N3 sleep on evenings following ECT treatments
Time frame: Up to 8 weeks during patients ECT treatment course
Total power of EEG slow waves per minute present during the first identified cycle of N3 sleep Range of values: 0 - 50 dB/min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Background: PubMed 20732629Lopez J, Hoffmann R, Armitage R. Reduced sleep spindle activity in early-onset and elevated risk for depression. J Am Acad Child Adolesc Psychiatry. 2010 Sep;49(9):934-43. doi: 10.1016/j.jaac.2010.05.014. Epub 2010 Jul 24.
- Background: PubMed 12972983Kho KH, van Vreeswijk MF, Simpson S, Zwinderman AH. A meta-analysis of electroconvulsive therapy efficacy in depression. J ECT. 2003 Sep;19(3):139-47. doi: 10.1097/00124509-200309000-00005.
- Derived from this study: PubMed 36030576Kafashan M, Brian Hickman L, Labonte AK, Huels ER, Maybrier H, Guay CS, Subramanian S, Farber NB, Ching S, Hogan RE, Kelz MB, Avidan MS, Mashour GA, Palanca BJA. Quiescence during burst suppression and postictal generalized EEG suppression are distinct patterns of activity. Clin Neurophysiol. 2022 Oct;142:125-132. doi: 10.1016/j.clinph.2022.07.493. Epub 2022 Jul 30.
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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.
MohammadMehdi Kafashan principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalographic (EEG), Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) and Ictal Electroencephalographic (EEG) Measurements in people with ECT and Treatment Resistant Depression, run by Washington University School of Medicine at 1 site in United States.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. 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 United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interval change in Quick Inventory of Depressive Symptomatology-16 Item Self Report (QIDS-SR16) between ECT sessions. (time frame: Up to 8 weeks during patients ECT treatment course). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04451135, which also lists 3 linked publications.
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 31 Dec 2025.