05/04/2024

Rejoyn 終於來了!FDA核准第一個治療重度憂鬱症 (MDD) 的處方數位療法

Rejoyn 終於來了!FDA核准第一個治療重度憂鬱症 (MDD) 的處方數位療法

蘇冠賓

中國醫藥大學 安南醫院副院長
精神醫學及神經科學教授 

由Otsuka與Click Therapeutics合作開發的Rejoyn,獲得FDA核准為首個治療重度憂鬱症 (MDD) 的處方數位療法。Rejoyn 為一種為期六週的療程,旨在透過結合經過臨床驗證的認知情緒訓練練習和簡短治療課程,幫助患者改善情緒控制能力。 不同於一般健康應用程式,Rejoyn是經FDA核准的醫療器材,需由醫療專業人員處方使用。


Otsuka and Click Therapeutics Announce the U.S. Food and Drug Administration (FDA) Clearance of Rejoyn™, the First Prescription Digital Therapeutic Authorized for the Adjunctive Treatment of Major Depressive Disorder (MDD) Symptoms. https://www.businesswire.com/news/home/20240401758231/en/




歐美治療指引建議常見身心疾病第一線治療是心理介入2023年英國NICE指引強調,治療輕中度憂鬱症不要以「開藥」做為常規,要和病人討論非藥物療法台灣健保資源有限,提供的是符合成本效益和社會公平的服務,無法根據臨床需求增加合理成本,來達到更好品質和效果的醫療服務。結果造成台灣精神疾病治療多以藥物為主,加上健保限制用藥成本,導致病人的治療常以最落伍的抗憂鬱劑、併用最便宜的安眠藥和鎮靜劑,以及於憂鬱症病人合併BZD使用的風險是國外2到6倍


二十一世紀人工智慧時代即將來臨,隨著人工智能進步和科技的創新,精神醫療服務的數位化是不可避免之趨勢,線上診療作為預防或治療輕度精神疾病應成為常規。英國的公醫健保和台灣一樣,即使治療指引強調非藥物治療,但面臨經費成本壓力,所以仍有70%的憂鬱症病人只以用藥為主。為了提高心理治療的普及、改善醫療資源不均的公平性、因應年輕族群最熟悉的求助方式、並減低個案求助專業的阻力,新版英國NICE指引推薦八種數位化、線上心理治療的App,在國民保健署 (NHS) 的治療師的支持下提供,用來治療憂鬱症和焦慮症未來的「情緒辨識科技、精神病理數位表徵、睡眠和腦部活動等資料常模建立」、「系統性、連續性、即時性、動態性數據型態」…,將把心靈健康的促進提升到不同的境界台灣有一流的醫療水準、大量臨床個案、完整健保資訊,若結合人工智能,推動精神醫療線上診斷和治療、以及健康資訊科技產業發展,以提供更完整的精神健康資訊,加速產業創新和技術轉移,促進精神健康醫療的升級和轉型。


Rejoyn的上世代表重度憂鬱症治療邁入新紀元。Rejoyn的核准是基於一項名為Mirai的大型臨床試驗數據。該試驗為期 13 週,多中心、遠距、雙盲、隨機對照試驗,納入 386 名正在服用抗憂鬱藥物治療憂鬱症的成年患者 (22-64 歲)。 試驗中,患者被隨機分配接受 Rejoyn 或安慰劑應用程式。 接受Rejoyn 治療的患者在憂鬱症狀嚴重程度方面在多個臨床評估量表上均觀察到優於對照組症狀改善的一致性。 在完成六週的療程後一個月,Rejoyn治療組的患者仍持續展現改善。試驗期間未觀察到任何與 Rejoyn 相關的副作用。


FDA approves first prescription-only digital treatment for depression


傳統的重度憂鬱症治療通常著重於改善腦內神經化學失衡,例如使用抗憂鬱藥物。 然而,近年研究發現,憂鬱症患者的大腦中負責情緒辨識、處理以及認知功能的區域之間的連結可能會出現異常,導致情緒調節更加困難。 Rejoyn透過設計特定的腦部訓練練習,靶向受憂鬱症影響的神經網絡,利用大腦本身俱有的可塑性來改變這些連接,從而達到減輕症狀的效果。


The six-weke program may stimulate the areas of the brain thought to be responsible for anti-depressant effects. 





1 comment:

  1. Rejoyn: A Fundamental Change in How Clinicians Can Treat MDD Symptoms
    https://www.psychiatrictimes.com/view/rejoyn-a-fundamental-change-in-how-clinicians-can-treat-mdd-symptoms

    April 11, 2024 Leah Kuntz John Kraus, MD, PhD News Article
    CLINICAL CONVERSATIONS
    Rejoyn (CT-152) recently became the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older who are on antidepressant medication. Rejoyn is expected to be available for download later in 2024. In the meantime, Psychiatric Times sat down with John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka, to learn more.

    PT: Can you describe Rejoyn in your own words? How and why is it effective?
    John Kraus, MD, PhD: Rejoyn (developed as CT-152) is a 6-week treatment intended to reduce MDD symptoms, delivered via smartphone app.

    Rejoyn is designed to help enhance cognitive control of emotion through a combination of clinically-validated cognitive emotional training exercises for the brain and brief therapeutic lessons. In the Mirai study, individuals treated with Rejoyn showed an improvement in depression symptoms from baseline. Symptom improvement was observed across multiple patient and clinician-reported scales, including the Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire nine-item depression scale (PHQ-9), and the Clinical Global Impression – Severity scale (CGI-S). One month after completing the 6-week treatment program, Rejoyn participants’ symptoms showed continued improvement. No side effects were assessed as related to Rejoyn during the trial.





    PT: Tell us a bit about the cognitive emotional training exercises included in Rejoyn’s 6-week program. Why is this approach novel?
    Kraus: Rejoyn offers a novel approach to the treatment of depression symptoms as it is designed to target neural networks affected by depression and is hypothesized to leverage the brain’s inherent neuroplasticity to alter those connections leading to symptom reduction over time. It introduces clinically-validated cognitive emotional brain training exercises (“Emotional Faces Memory Task” or “EFMT”) that were conceived and conceptually proven by a team of psychologists, psychiatrists, and neuroscientists. These brain exercises are designed to target and help alter those neural connections necessary to appropriately process emotions with the goal of reducing symptoms of depression.

    For your reference, Rejoyn’s 6-week treatment program is composed of:
    1. Clinically-validated cognitive emotional training exercises for the brain, which are designed to target and help alter the neural connections necessary to appropriately process emotions with the goal of reducing symptoms of depression. A neuromodulatory mechanism acts like physical therapy for the brain by delivering personalized, consistent brain-training exercises designed to help improve connections in the brain regions affected by depression symptoms. By creating stronger connections, the parts of the brain responsible for emotions and regulating emotions are better able to work together to process those emotions more appropriately.

    2. Brief therapeutic lessons to teach skills that can help manage depression symptoms, including handling strong emotions, reframing negative thinking, and engaging in positive actions.

    3. In-app notifications and SMS messages to reinforce lesson content and encourage engagement with the treatment program.

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