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Effects of General Anaesthetic Agents on the Efficacy of Electroconvulsive Therapy and EEG Changes in Patients with Depression

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524829-40-00
Enrollment
174
Registered
2026-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe unipolar depression treated with electroconvulsive therapy

Brief summary

The primary endpoint is the time to first clinical response, measured as the number of completed ECT sessions from treatment initiation to the first MADRS (Montgomery-Åsberg Depression Rating Scale) assessment showing a reduction of at least 50% from baseline.

Detailed description

The key secondary endpoint is the number of completed ECT sessions from treatment initiation to the first MADRS assessment showing a total score of <12., EEG-based endpoints comprise measures of anaesthetic depth derived from multichannel EEG before stimulus administration, seizure characteristics including seizure duration, amplitude, postictal suppression index, the presence of epileptiform discharges or burst suppression patterns, detection of non-convulsive seizures following ECT and comparisons between ECT/Thymatron frontal EEG and full-head EEG parameters., Clinical secondary endpoints include the incidence of adverse events related to anaesthesia or ECT, haemodynamic responses to anaesthesia induction and stimulus delivery, cognitive adverse effects, and patient-reported depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9), completed by the patient after the first, the sixth and the last ECT session.

Interventions

DRUGPROPOFOL
DRUGETOMIDATE

Sponsors

Varsinais-Suomen hyvinvointialue
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the time to first clinical response, measured as the number of completed ECT sessions from treatment initiation to the first MADRS (Montgomery-Åsberg Depression Rating Scale) assessment showing a reduction of at least 50% from baseline.

Secondary

MeasureTime frame
The key secondary endpoint is the number of completed ECT sessions from treatment initiation to the first MADRS assessment showing a total score of <12., EEG-based endpoints comprise measures of anaesthetic depth derived from multichannel EEG before stimulus administration, seizure characteristics including seizure duration, amplitude, postictal suppression index, the presence of epileptiform discharges or burst suppression patterns, detection of non-convulsive seizures following ECT and comparisons between ECT/Thymatron frontal EEG and full-head EEG parameters., Clinical secondary endpoints include the incidence of adverse events related to anaesthesia or ECT, haemodynamic responses to anaesthesia induction and stimulus delivery, cognitive adverse effects, and patient-reported depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9), completed by the patient after the first, the sixth and the last ECT session.

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 16, 2026