抑郁症磁惊厥疗法的验证性疗效和安全性试验 (CREST-MST)

实验性的：磁痉挛疗法 (MST)

MST 治疗将使用带有 Cool TwinCoil 的 MagPro MST 进行。

设备：磁痉挛疗法

MST 治疗将使用带有 Cool TwinCoil 的 MagPro MST 在中线位置使用 100 Hz 刺激在额叶皮质上进行。 癫痫发作阈值的 MST 确定将使用 100% 的机器输出以 100 Hz 的频率逐渐增加列车持续时间，从 2 秒开始，每次后续刺激增加 2 秒，直到产生足够的癫痫发作。 在随后的会话中，将使用比阈值处的训练持续时间长 4 秒的训练持续时间（最长训练持续时间为 10 秒）来提供一种刺激。

这将在麻醉作用下进行。 治疗过程大约需要 10 分钟，然后是大约 30 分钟的恢复期。

其他名称：

• MST

有源比较器：Electroconvulsive Therapy (ECT)

ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.

设备：Electroconvulsive Therapy

In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes

其他名称：

• 心电图

Remission of Depression on the Hamilton Rating Scale for Depression-24 Item (HRSD-24)

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.

Worsening of Autobiographical Memory on the Autobiographical Memory Test (AMT)

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 on the Scale for Suicidal Ideation (SSI)

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.

Response on the Hamilton Rating Scale for Depression-24 Item (HRSD-24)

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.

Score on the Brief Symptom Inventory Anxiety Section (BSI-A)

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.

Response on the Clinical Global Impression - Improvement Scale (CGI-I)

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.

Score on the Quality-of-Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

The Q-LES-Q-SF (Short Form) measures quality of life through 14 items, each rated on a 1-5 scale (1=Very Poor, 5=Very Good). Total raw scores range from 14 to 70, with higher scores indicating greater satisfaction.

Score on the Columbia ECT Subjective Side Effects Schedule (CSSES)

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.