Prova di conferma dell'efficacia e della sicurezza della terapia magnetica per la depressione (CREST-MST)

Il trattamento MST verrà somministrato utilizzando il MagPro MST con un Cool TwinCoil sopra la corteccia frontale nella posizione della linea mediana utilizzando la stimolazione a 100 Hz. La determinazione MST della soglia convulsiva verrà effettuata utilizzando l'uscita della macchina al 100% applicata a 100 Hz a durate del treno progressivamente crescenti, iniziando a 2 secondi e aumentando di 2 secondi con ogni successiva stimolazione fino a quando non viene prodotto un adeguato attacco. Durante le sessioni successive, verrà erogata una stimolazione utilizzando una durata del treno che è 4 secondi più lunga della durata del treno alla soglia (con una durata massima del treno di 10 secondi).

Questo sarà eseguito sotto l'effetto dell'anestesia. La procedura di trattamento è di circa 10 minuti, seguita da un periodo di recupero di circa 30 minuti.

• MST

• ECT

This scale is used to quantify the severity of symptoms of depression

• Scale range: 0-76 (total score)
• Lower scores indicate lower severity of depressive symptoms (i.e., better outcome)
• Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome) Remission defined as a HRSD-24 total score of ≤10 and 60% reduction from baseline on two consecutive assessments.

The outcome is reported as number of participants meeting remission criteria in each treatment group.

In the Autobiographical Memory Test (AMT), participants are presented with emotional cue words and asked to retrieve a personal memory within a brief response window; interview formats have been shown to produce fewer specific and more overgeneral memories.

The outcome is reported as the number of participants who meet the predefined worsening criterion at follow-up.

The binary outcome was defined as a worsening from baseline of >25% on the AMT total score.

Remission of suicidal ideation will be assessed using the Scale for Suicidal Ideation (SSI), a clinician-administered tool with 19 scored items rated 0-2, total score range 0-38. Higher scores indicate greater suicidal ideation severity.

Remission is defined as an SSI total score of 0 at follow-up. The outcome is the number of participants who meet remission criteria compared with baseline.

This scale is used to quantify the severity of symptoms of depression

• Scale range: 0-76 (total score)
• Lower scores indicate lower severity of depressive symptoms (i.e., better outcome)
• Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome) Response is defined as a HRSD-24 reduction of 50% or greater from baseline The outcome is reported as number of participants meeting response criteria in each treatment group.

The Brief Symptom Inventory (BSI) anxiety section (ANX) is a subscale comprised of 6 items designed to measure subjective experiences of tension, panic, and restlessness over the past week. It uses a 5-point Likert scale (0=not at all to 4=extremely) to identify symptoms like "nervousness," "feeling tense," or "spells of terror".

Higher = worse; lower = better. The total score ranges from 0 to 24.

The Clinical Global Impression-Improvement (CGI-I) scale is a 7-point, observer-rated tool used to measure how much a patient's illness has improved or worsened relative to their baseline. It is rated from 1 (very much improved) to 7 (very much worse).

Response is defined as a CGI-I score of 1 or 2.

The Columbia ECT Subjective Side Effects Schedule is a tool used to monitor adverse effects after each ECT session and at baseline. It tracks physical, cognitive, and mood side effects.

For the physical scale (range 0-15) and cognitive scale (range 0-6) it uses a 4-point Likert-type scale where 0 = none; 1 = yes, mild; 2 = yes, moderate; and 3 = yes, severe.

For the mood scale (range 0-3) it uses a 2-point Likert-type scale where 0 = no; 1 = yes.

For the physical and cognitive scales, higher values indicate a worse outcome. For the mood scale, higher values indicate a better outcome.