우울증에 대한 전자기 경련 요법: 비열등성 연구 (EMCODE)
전기 충격 요법 대 자기 발작 요법: 임상 및 인지 결과
This study aims to compare the efficacy and safety profile of Magnetic Seizure Therapy and Electroconvulsive therapy.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Magnetic seizure therapy (MST) is a novel, experimental therapeutic intervention, which combines therapeutic aspects of electroconvulsive therapy (ECT) and transcranial magnetic stimulation, in order to achieve the efficacy of the former with the safety of the latter. While ECT remains the most efficacious treatment available for severe and treatment-resistant depression, it is hampered by its side effect profile, specially cognitive deficits, which albeit transitory might be particularly distressing for patient, not to mention the stigma that still clings to this method. MST employs high frequency magnetic pulses applied to the head to the patient in order to induce generalized epileptic activity, thus emulating the core feature of ECT. Though distributed over a large area, such pulses do not penetrate deeper areas of the brain, therefore sparing deeper areas such as the hippocampi, which are crucial for memory encoding.
The goal of this study is to compare the antidepressant action and safety profile of MST to ECT, using a non-inferiority approach. It also aims to compare the cognitive side effects profile of both interventions, as well as investigate possible neuroimaging changes and response predictors before and after treatments.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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São Paulo
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São Paulo, São Paulo, 브라질
- Institute of Psychiatry, HC-FMUSP
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Major Depressive Disorder or Bipolar Depression in accordance to the Diagnostic and Statistical Manual (DSM) criteria
- Score equal to or great than 17 points on the Hamilton Depression Rating Scale
- Treatment-resistant depression, defined as insufficient relief of symptoms after two different first line treatments using therapeutic doses and for four to six weeks
- Adequate health and clinical conditions, as assessed by an anaesthesiologist and a psychiatrist
Exclusion Criteria:
- Pregnancy
- Other psychiatric conditions such as Schizophrenia, Schizoaffective Disorder, Substance Abuse, Borderline Personality Disorder, PTSD, or Intellectual Deficiency
- Depressive symptoms due to a clinical condition
- Any clinical or neurological conditions without proper management
- ECT or any other neuromodulation treatment on the last six months
- Inability to consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: MST
Subjects will receive 12-18 sessions of frontal Magnetic Seizure Therapy under general anaesthesia, twice a week. Clinical and cognitive measures will be assessed before, during and after the treatment |
Subjects will receive a train of magnetic pulses (between 600 and 1400 pulses) at 100Hz under general anaesthesia using a Magventure device with a Twin Coil
다른 이름들:
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활성 비교기: ECT
Subjects will receive 12-18 sessions of bilateral Electroconvulsive Therapy under general anaesthesia, twice a week. Clinical and cognitive measures will be assessed before, during and after the treatment |
Subjects will receive a brief-pulse electrical stimulus (between 25 and 1008mC) under general anaesthesia using a ECT device
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Depressive symptoms
기간: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
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Score on the 17 items Hamilton Depression Rating Scale (HDRS-17). It measures the severity of clinical symptoms, ranging from 0 to 52, with higher scores indicating greater severity. |
Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
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Biographical memory
기간: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
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Score on the Autobiographical Memory Inventory (AMI). Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity. |
Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Depressive Symptoms
기간: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
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Score on the Montgomery-Asberg Depression Rating Scale (MADRS). It measures the severity of clinical symptoms, ranging from 0 to 60, with higher scores indicating greater severity. |
Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
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Depressive Symptoms
기간: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
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Score on the Beck Depression Inventory (BDI). It measures the severity of clinical symptoms, ranging from 0 to 63, with higher scores indicating greater severity. |
Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
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Suicidal Thoughts
기간: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
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Score on the Beck Scale for Suicidal Ideation (BSS). The BSS contains 19 items that measure the severity of actual suicidal wishes and plans. Scores range from 0 to 38, a higher score indicating a higher level of suicide ideation. |
Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: ANDRE R BRUNONI, FACULDADE DE MEDICINA DA USP
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 29979220.4.0000.0068
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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