Treatment Resistant DepressionDNS-ECTNCT05905705
Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy
An observational study of Treatment Resistant Depression, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Electroconvulsive therapy (ECT) alleviates treatment-resistant depression (TRD) through repeated generalized seizures. The goal of this study is to evaluate how ECT impacts sleep-wake regulation and efficiency of information transfer in functional networks in different states of arousal. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Electroencephalography (EEG) and Quantitative Measurements of Sleep Microstructure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 31 Jul 2027
- Phase
- Observational
- 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 21 to 65 years
- All sexes
- Adult, Older adult
Study population: Treatment-Resistant Depression (TRD), unipolar major depressive disorder or bipolar depression
Who may be able to join
- Referral for initial ECT index course for Treatment-Resistant Depression (TRD), unipolar major depressive disorder or bipolar depression. Historic failure of response or remission to at least two antidepressant medications of sufficient dose and duration will be used for TRD diagnostic.
Who cannot join
- Diagnoses of schizophrenia or schizoaffective disorders.
- Subjects who are unable to tolerate the Dreem device for sleep recordings will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, 63110
Robby Greenspan, 314-273-6129, greenspan@wustl.edu
About this study
Electroconvulsive therapy (ECT) alleviates treatment-resistant depression (TRD) through repeated generalized seizures. The goal of this study is to evaluate how ECT impacts sleep-wake regulation and efficiency of information transfer in functional networks in different states of arousal.
Read the detailed description
Graph-based network analyses of electroencephalographic (EEG) signals allow characterization of functional networks. The robustness of local networks to disruption is quantified as local efficiency (Elocal), while network integration is quantified as global information transfer (Eglobal).
Aim 1: Assess relationships between sleep slow-wave activity (SWA) and awake Elocal over the course of ECT.
Aim 2: Quantify relationships between depression severity and awake Elocal over the course of ECT.
- Conditions
- Treatment Resistant Depression
- Being tested
- Electroencephalography (EEG), Quantitative Measurements of Sleep Microstructure
- 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.
Electroencephalography (EEG)Diagnostic test
High-density EEG will be acquired during resting wakefulness before each ECT session.
Quantitative Measurements of Sleep MicrostructureDiagnostic test
Overnight sleep EEG will be recorded one day before each ECT session using the DREEM device. The DREEM device allows continuous recording of multichannel EEG.
What is being measured
The primary outcome is the main question the study is designed to answer.
Slow wave activity (SWA) during non-rapid eye movement sleep (NREM) stage N2/N3
Total power of EEG slow waves per minute present during N2/N3 sleep
Measured: Up to 4 weeks during patients ECT treatment course
Graph-based neural connectivity measure of local efficiency of information transfer (Elocal) during wakefulness
Elocal will be calculated as the average inverse shortest path length among neighbors of a node within the network. Nodes will be constructed based on 5-minute recordings of eyes closed wakefulness theta band (4-8 Hz) EEG.
Measured: Up to 4 weeks during patients ECT treatment course
Graph-based neural connectivity measure of global information transfer (Eglobal) during ECT-induced seizure
Eglobal will be calculated as the average inverse shortest path length between node pairs in the networks. Nodes will be constructed based on ECT-induced seizure EEG data within the alpha band (8-13 Hz).
Measured: Up to 4 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 posted15 Jun 2023
- Study start7 Mar 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 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 Treatment Resistant DepressionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, MohammadMehdi Kafashan, Washington University School of Medicine
- Investigators
- MohammadMehdi Kafashan, Principal investigator, Washington University School of Medicine in St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905705
- Sponsor's protocol ID
- 202204161
- Other IDs
- K01MH128663
- Acronym
- DNS-ECT
- Status last verified
- Mar 2026
- First submitted
- 6 Jun 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Subramanian S, Labonte AK, Nguyen T, Luong AH, Hyche O, Smith SK, Hogan RE, Farber NB, Palanca BJA, Kafashan M; CET-REM Study Group. Correlating electroconvulsive therapy response to electroencephalographic markers: Study protocol. Front Psychiatry. 2022 Nov 3;13:996733. doi: 10.3389/fpsyt.2022.996733. eCollection 2022.
PubMed 36405897Hill AT, Zomorrodi R, Hadas I, Farzan F, Voineskos D, Throop A, Fitzgerald PB, Blumberger DM, Daskalakis ZJ. Resting-state electroencephalographic functional network alterations in major depressive disorder following magnetic seizure therapy. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Jun 8;108:110082. doi: 10.1016/j.pnpbp.2020.110082. Epub 2020 Aug 24.
PubMed 32853716Kafashan M, Lebovitz L, Greenspan R, Zhao S, Kim T, Husain M, Hershey T, Cristancho P, Hogan RE, Palanca BJA, Farber NB; DNS-ECT Study Team. Investigating the impact of electroconvulsive therapy on brain networks and sleep: an observational study protocol. BMJ Open. 2025 Mar 7;15(3):e098859. doi: 10.1136/bmjopen-2025-098859.
PubMed 40054874
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disruptions of Brain Networks and Sleep by Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT05905705
- Acronym / sponsor ID
- DNS-ECT / 202204161
- Conditions
- Treatment Resistant Depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 15 Jun 2023 (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.
Electroconvulsive therapy (ECT) alleviates treatment-resistant depression (TRD) through repeated generalized seizures. The goal of this study is to evaluate how ECT impacts sleep-wake regulation and efficiency of information transfer in functional networks in different states of arousal.
Detailed description
Graph-based network analyses of electroencephalographic (EEG) signals allow characterization of functional networks. The robustness of local networks to disruption is quantified as local efficiency (Elocal), while network integration is quantified as global information transfer (Eglobal).
Aim 1: Assess relationships between sleep slow-wave activity (SWA) and awake Elocal over the course of ECT.
Aim 2: Quantify relationships between depression severity and awake Elocal over the course of ECT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Treatment-Resistant Depression (TRD), unipolar major depressive disorder or bipolar depression
Key inclusion criteria (1 listed)
- Referral for initial ECT index course for Treatment-Resistant Depression (TRD), unipolar major depressive disorder or bipolar depression. Historic failure of response or remission to at least two antidepressant medications of sufficient dose and duration will be used for TRD diagnostic.
Key exclusion criteria (2 listed)
- Diagnoses of schizophrenia or schizoaffective disorders.
- Subjects who are unable to tolerate the Dreem device for sleep recordings will be excluded from the study.
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 |
|---|---|---|
| Electroencephalography (EEG)High-density EEG will be acquired during resting wakefulness before each ECT session. | Diagnostic test | – |
| Quantitative Measurements of Sleep MicrostructureOvernight sleep EEG will be recorded one day before each ECT session using the DREEM device. The DREEM device allows continuous recording of multichannel EEG. | Diagnostic test | – |
Primary outcome
Slow wave activity (SWA) during non-rapid eye movement sleep (NREM) stage N2/N3
Time frame: Up to 4 weeks during patients ECT treatment course
Total power of EEG slow waves per minute present during N2/N3 sleep
Graph-based neural connectivity measure of local efficiency of information transfer (Elocal) during wakefulness
Time frame: Up to 4 weeks during patients ECT treatment course
Elocal will be calculated as the average inverse shortest path length among neighbors of a node within the network. Nodes will be constructed based on 5-minute recordings of eyes closed wakefulness theta band (4-8 Hz) EEG.
Graph-based neural connectivity measure of global information transfer (Eglobal) during ECT-induced seizure
Time frame: Up to 4 weeks during patients ECT treatment course
Eglobal will be calculated as the average inverse shortest path length between node pairs in the networks. Nodes will be constructed based on ECT-induced seizure EEG data within the alpha band (8-13 Hz).
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 12 Mar 2026.
- Background: PubMed 36405897Subramanian S, Labonte AK, Nguyen T, Luong AH, Hyche O, Smith SK, Hogan RE, Farber NB, Palanca BJA, Kafashan M; CET-REM Study Group. Correlating electroconvulsive therapy response to electroencephalographic markers: Study protocol. Front Psychiatry. 2022 Nov 3;13:996733. doi: 10.3389/fpsyt.2022.996733. eCollection 2022.
- Background: PubMed 32853716Hill AT, Zomorrodi R, Hadas I, Farzan F, Voineskos D, Throop A, Fitzgerald PB, Blumberger DM, Daskalakis ZJ. Resting-state electroencephalographic functional network alterations in major depressive disorder following magnetic seizure therapy. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Jun 8;108:110082. doi: 10.1016/j.pnpbp.2020.110082. Epub 2020 Aug 24.
- Derived from this study: PubMed 40054874Kafashan M, Lebovitz L, Greenspan R, Zhao S, Kim T, Husain M, Hershey T, Cristancho P, Hogan RE, Palanca BJA, Farber NB; DNS-ECT Study Team. Investigating the impact of electroconvulsive therapy on brain networks and sleep: an observational study protocol. BMJ Open. 2025 Mar 7;15(3):e098859. doi: 10.1136/bmjopen-2025-098859.
- Individual participant dataSharing planned: Undecided
Related trials for Treatment Resistant Depression
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression
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.
MohammadMehdi Kafashan principal investigator
Washington University School of Medicine in St. Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. 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?
Contact Robby Greenspan (314-273-6129, greenspan@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slow wave activity (SWA) during non-rapid eye movement sleep (NREM) stage N2/N3 (time frame: Up to 4 weeks during patients ECT treatment course). The study lists 3 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 NCT05905705, 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 12 Mar 2026.