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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Merve rANA Altunel Ülkü, MD
- 電話番号：+90 506 303 10 68
- メール：ranaltunel@gmail.com
研究場所
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Istanbul、トルコ（Türkiye）、34000
- 募集
- Istanbul University - Cerrahpasa
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コンタクト：
- Merve rANA Altunel Ülkü, MD
- 電話番号：+90 506 303 10 68
- メール：ranaltunel@gmail.com
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コンタクト：
- Cana Aksoy Poyraz, Prof. Dr.
- 電話番号：+90 532 715 95 04
- メール：aksoycana@gmail.com
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主任研究者：
- Merve Rana Altunel Ülkü, MD
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副調査官：
- Cana Aksoy Poyraz, Prof. Dr.
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Hamilton Depression Rating Scale (HAM-D) Score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Treatment Response Rate Based on HAM-D
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- スタディチェア：Cana Aksoy Poyraz, Prof. Dr.、Istanbul University - Cerrahpasa
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- E-24687260-604.01-1433619
- TTU-2025-38714 (その他の助成金/資金番号：IU-Cerrahpasa Scientific Research Projects Unit)
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個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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