A randomized sham controlled comparison of once vs twice-daily intermittent theta burst stimulation in depression: A Canadian rTMS treatment and biomarker network in depression (CARTBIND) study,Brain Stimulation

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A randomized sham controlled comparison of once vs twice-daily intermittent theta burst stimulation in depression: A Canadian rTMS treatment and biomarker network in depression (CARTBIND) study
Brain Stimulation ( IF 7.7 ) Pub Date : 2021-09-21 , DOI: 10.1016/j.brs.2021.09.003
Daniel M Blumberger ₁ , Fidel Vila-Rodriguez ₂ , Wei Wang ₃ , Yuliya Knyahnytska ₁ , Michael Butterfield ₂ , Yoshihiro Noda ₄ , Shahak Yariv ₅ , Moshe Isserles ₆ , Daphne Voineskos ₁ , Nicholas J Ainsworth ₂ , Sidney H Kennedy ₇ , Raymond W Lam ₂ , Zafiris J Daskalakis ₈ , Jonathan Downar ₉

Affiliation

Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, M6J1H4, Canada; Department of Psychiatry and Institute of Medical Science, Faculty of Medicine, University of Toronto, Toronto, M5S 1A8, Canada.
Department of Psychiatry, University of British Columbia, Vancouver, V6T 2A1, Canada.
Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, M6J1H4, Canada; College of Public Health, University of South Florida, Tampa, 33612, USA.
Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, 160-8582, Japan.
Department of Psychiary, Emek Medical Center General Hospital, Afula, 1834111, Israel; Faculty of Medicine, Technion- Israel Institute of Technology, Haifa, 3525433, Israel.
The Jerusalem Center for Mental Health, Jerusalem, 91060, Israel.
Department of Psychiatry and Institute of Medical Science, Faculty of Medicine, University of Toronto, Toronto, M5S 1A8, Canada; St. Michaels Hospital, Unity Health, Toronto, ON, M5B 1W8, Canada; Centre for Mental Health and Krembil Research Institute, University Health Network, Toronto, M5T 0S8, Canada.
Department of Psychiatry, University of California San Diego, California, USA, 92093.
Department of Psychiatry and Institute of Medical Science, Faculty of Medicine, University of Toronto, Toronto, M5S 1A8, Canada; Centre for Mental Health and Krembil Research Institute, University Health Network, Toronto, M5T 0S8, Canada.

Background

Intermittent theta burst stimulation (iTBS) is a newer form of repetitive transcranial magnetic stimulation (rTMS) for patients with treatment resistant depression (TRD). Applying multiple daily iTBS sessions may enable patients to achieve remission more rapidly.

Objective

We compared the efficacy and tolerability of a twice-daily versus once-daily iTBS protocol in patients with TRD. We hypothesized that twice-daily iTBS would result in a greater improvement in depression scores compared to once-daily iTBS.

Methods

208 participants (131 females) with TRD were randomized to receive either iTBS (600 pulses) delivered twice-daily with a 54-min interval between treatments or once-daily (1200 pulses) with 1 sham treatment with the same interval between treatments, to ensure equal levels of daily therapeutic contact and blinding of patients and raters. The primary outcome measure was change in depression scores on the Hamilton Rating Scale for Depression (HRSD-17) after 10 days of treatment and 30 days of treatments.

Results

HRSD-17 scores improved in both the twice-daily and once-daily iTBS groups; however, these improvements did not significantly differ between the two groups at either the 10-day or 30-day timepoints. Response and remission rates were low (<10%) in both groups after 10 days and consistent with prior reports at 30 days; these rates did not differ between the treatment groups.

Conclusions

These results suggest that twice-daily iTBS does not accelerate response to iTBS and is not different from once-daily treatment in terms of improving depressive symptoms in patients with TRD.

Clinicaltrials.gov ID: NCT02729792 (https://clinicaltrials.gov/ct2/show/NCT02729792)

中文翻译：

抑郁症中一次与每天两次间歇性 theta 爆发刺激的随机假对照比较：加拿大 rTMS 治疗和抑郁症生物标志物网络 (CARTBIND) 研究

背景

间歇性 theta 脉冲刺激 (iTBS) 是一种新形式的重复经颅磁刺激 (rTMS)，适用于难治性抑郁症 (TRD) 患者。应用多个每日 iTBS 会话可以使患者更快地实现缓解。

客观的

我们比较了每天两次与每天一次 iTBS 方案在 TRD 患者中的疗效和耐受性。我们假设与每天一次的 iTBS 相比，每天两次的 iTBS 会导致抑郁评分有更大的改善。

方法

208 名 TRD 参与者（131 名女性）被随机分配接受每天两次的 iTBS（600 次脉冲），治疗之间间隔 54 分钟，或每天一次（1200 次脉冲）接受 1 次假治疗，治疗之间的间隔相同，以确保患者和评估者的日常治疗接触和盲法水平相同。主要结果测量是治疗 10 天和治疗 30 天后汉密尔顿抑郁评定量表 (HRSD-17) 上抑郁评分的变化。