Accelerated iTBS for Major Depression (AIM-D)
Investigation of the Relationship Between Changes in Neurobiological Biomarkers After Accelerated Transcranial Magnetic Stimulation Treatment and Treatment Response in Patients With Major Depressive Disorder
연구 개요
상태
상세 설명
Major depressive disorder (MDD) is a highly prevalent and disabling psychiatric disorder. A substantial proportion of patients do not achieve sufficient improvement with conventional antidepressant treatments, resulting in treatment-resistant or difficult-to-treat depression. Noninvasive neuromodulation approaches such as transcranial magnetic stimulation (TMS) have emerged as effective alternatives for these patients. Accelerated intermittent theta burst stimulation (iTBS), delivered in multiple daily sessions over a short period, may provide faster clinical improvement compared with conventional protocols.
This prospective single-arm interventional study aims to evaluate the clinical efficacy and biological correlates of accelerated bilateral dorsomedial prefrontal cortex (DMPFC) iTBS in adults with MDD who have shown inadequate response to at least one adequate antidepressant treatment trial.
Participants aged 18 to 65 years will receive accelerated bilateral DMPFC iTBS for five consecutive days, with four sessions per day (20 total sessions). Participants demonstrating partial clinical improvement without remission after 20 sessions may receive an additional 10 sessions according to clinical evaluation.
Clinical assessments will be performed at baseline, during treatment, at the end of treatment, and at one-month follow-up. Outcome measures include Hamilton Depression Rating Scale (HAM-D), Beck Depression Inventory, Beck Anxiety Inventory, suicidal ideation measures, self-rated depressive symptom scales, and Clinical Global Impression ratings.
Blood samples will be collected at baseline and after treatment to evaluate neurobiological biomarkers, including cortisol, adrenocorticotropic hormone (ACTH), brain-derived neurotrophic factor (BDNF), interleukin-1 beta (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP).
The primary objective is to determine treatment response based on reduction in depressive symptom severity. Secondary objectives are to examine biomarker changes associated with treatment, identify predictors of response, and explore the relationship between early symptom improvement and final clinical outcomes.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Merve rANA Altunel Ülkü, MD
- 전화번호: +90 506 303 10 68
- 이메일: ranaltunel@gmail.com
연구 장소
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Istanbul, 터키 (Türkiye), 34000
- 모병
- Istanbul University - Cerrahpasa
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연락하다:
- Merve rANA Altunel Ülkü, MD
- 전화번호: +90 506 303 10 68
- 이메일: ranaltunel@gmail.com
-
연락하다:
- Cana Aksoy Poyraz, Prof. Dr.
- 전화번호: +90 532 715 95 04
- 이메일: aksoycana@gmail.com
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수석 연구원:
- Merve Rana Altunel Ülkü, MD
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부수사관:
- Cana Aksoy Poyraz, Prof. Dr.
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age between 18 and 65 years
- Diagnosis of Major Depressive Disorder according to DSM-5 criteria
- Inadequate response to at least one adequate antidepressant treatment trial
- Hamilton Depression Rating Scale (HAM-D) score ≥14 at baseline
- Stable dose of antidepressant medication for at least 4 weeks prior to study entry
- Ability to provide written informed consent
Exclusion Criteria:
- History of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic depression
- Current substance use disorder
- Neurological disorders that may affect brain function (e.g., epilepsy, multiple sclerosis, dementia, Parkinson's disease)
- History of epileptic seizures
- Severe head trauma
- Presence of metal implants in the head or neck region
- Cochlear implants
- Cardiac pacemaker or implanted electronic devices
- History of deep brain stimulation or vagus nerve stimulation
- Previous neurosurgical procedures
- Pregnancy or breastfeeding
- Use of medications that may significantly affect neuroendocrine or inflammatory markers (e.g., corticosteroids, immunomodulators)
- Endocrine disorders affecting the hypothalamic-pituitary-adrenal axis (e.g., Cushing's syndrome, Addison's disease, thyroid disorders)
- Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, Hashimoto thyroiditis)
- Recent surgery or acute infection
- Active suicidal crisis, severe agitation, or inability to comply with study procedures
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Accelerated iTBS
Participants receive accelerated bilateral dorsomedial prefrontal cortex intermittent theta burst stimulation (iTBS) administered over five consecutive days, with four sessions per day (20 sessions total).
Participants with partial clinical response may receive an additional 10 sessions.
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Accelerated intermittent theta burst stimulation (iTBS) is administered bilaterally to the dorsomedial prefrontal cortex using a double-cone coil, targeting the stimulation site based on anatomical landmarks.
Treatment is delivered over five consecutive days with four sessions per day (total of 20 sessions).
Each session consists of 600 pulses per hemisphere (1200 pulses total) at an intensity of 120% of the individual motor threshold.
Participants with partial response may receive an additional 10 sessions.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Hamilton Depression Rating Scale (HAM-D) Score
기간: Baseline, within 3 days after completion of treatment and 1-month follow-up
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Change in depressive symptom severity measured by the 17-item Hamilton Depression Rating Scale (HAM-D-17).
Scores range from 0 to 53, with higher scores indicating greater depression severity.
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Baseline, within 3 days after completion of treatment and 1-month follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Treatment Response Rate Based on HAM-D
기간: within 3 days after completion of treatment
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Proportion of participants achieving ≥50% reduction in HAM-D score from baseline.
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within 3 days after completion of treatment
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Remission Rate Based on HAM-D
기간: Within 3 days after completion of treatment
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Proportion of participants achieving remission defined as HAM-D score ≤7.
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Within 3 days after completion of treatment
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Sustained Treatment Response at 1-Month Follow-Up
기간: 1 month after treatment completion
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Proportion of participants maintaining ≥50% reduction in HAM-D score at 1-month follow-up.
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1 month after treatment completion
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Sustained Remission at 1-Month Follow-Up
기간: 1 month after treatment completion
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Proportion of participants maintaining remission, defined as HAM-D score ≤7, at 1-month follow-up.
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1 month after treatment completion
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Change in Serum Cortisol and ACTH Levels
기간: Baseline, within 3 days after completion of treatment and 1-month follow-up
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Change in serum cortisol and adrenocorticotropic hormone (ACTH) levels following treatment.
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Baseline, within 3 days after completion of treatment and 1-month follow-up
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Change in Serum BDNF Levels
기간: Baseline, within 3 days after completion of treatment, and 1-month follow-up
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Change in serum brain-derived neurotrophic factor (BDNF) levels following treatment.
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Baseline, within 3 days after completion of treatment, and 1-month follow-up
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Change in Inflammatory Biomarkers
기간: Baseline, within 3 days after completion of treatment, and 1-month follow-up
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Change in serum IL-1β, IL-6, TNF-α, and C-reactive protein (CRP) levels following treatment.
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Baseline, within 3 days after completion of treatment, and 1-month follow-up
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Change in Beck Depression Inventory (BDI) Score
기간: Baseline, within 3 days after completion of treatment, and 1-month follow-up
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Change in depressive symptom severity measured by the Beck Depression Inventory(BDI).
Scores range from 0 to 63, with higher scores indicating greater depressive symptom severity.
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Baseline, within 3 days after completion of treatment, and 1-month follow-up
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Change in Beck Anxiety Inventory (BAI) Score
기간: Baseline, end of treatment, and 1-month follow-up
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Change in anxiety symptom severity measured by the Beck Anxiety Inventory (BAI).
Scores range from 0 to 63, with higher scores indicating greater anxiety severity.
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Baseline, end of treatment, and 1-month follow-up
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Change in Clinical Global Impression (CGI) Score
기간: Baseline, within 3 days after completion of treatment and 1-month follow-up
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The scale includes three clinician-rated dimensions assessing illness severity (1-7), clinical improvement (1-7), and side effect severity (1-4).
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Baseline, within 3 days after completion of treatment and 1-month follow-up
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공동 작업자 및 조사자
수사관
- 연구 의자: Cana Aksoy Poyraz, Prof. Dr., Istanbul University - Cerrahpasa
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- E-24687260-604.01-1433619
- TTU-2025-38714 (기타 보조금/기금 번호: IU-Cerrahpasa Scientific Research Projects Unit)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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