Recruiting

ECT

Sponsor:

Washington University School of Medicine

Code:

NCT05905705

Conditions

Treatment Resistant Depression

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Electroencephalography (EEG)

Quantitative Measurements of Sleep Microstructure

Study Details

Brief 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.

Conditions

Treatment Resistant Depression

Study ID

NCT05905705

Start date

Mar 7, 2023

Status verified date

Mar, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Diagnoses of schizophrenia or schizoaffective disorders.
  • Subjects who are unable to tolerate the Dreem device for sleep recordings will be excluded from the study.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

Electroencephalography (EEG)

High-density EEG will be acquired during resting wakefulness before each ECT session.

Quantitative Measurements of Sleep Microstructure

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.

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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Washington University School of Medicine/Barnes-Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

More Information

Sponsor

Washington University School of Medicine

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-03-12.