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

Condition studied

Severe unipolar depression treated with electroconvulsive therapy

Investigational medicinal product(s)

Eligibility

Primary endpoint

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.

Endpoint detail

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.