PDF(Pubmed)
Abstract：
BACKGROUND: Symptoms of anxiety and depression are common in patients with terminal illness and multiple challenges exist with timely and effective care in this population. Several centres have reported that one dose of the serotonergic psychedelic psilocybin, combined with therapeutic support, improves these symptoms for up to 6 months in this patient group. Drawing upon related therapeutic mechanisms, 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy may have the potential to achieve similar, positive mental health outcomes in this group. Preliminary evidence also supports the tolerability of MDMA-assisted therapy for anxiety and depression in advanced-stage cancer.
METHODS: Up to 32 participants with advanced-stage cancer and associated depression and anxiety will be randomised in a 1:1 ratio into one of two blinded parallel treatment arms. The intervention group will receive 120 mg (+ 60 mg optional supplemental dose) MDMA-assisted therapy. The psychoactive control group will receive 20 mg oral (+ 10 mg optional supplemental dose) methylphenidate-assisted therapy. For each medication-assisted therapy session, participants will undergo two 90-min therapeutic support sessions in the week preceding, and one 90-min support session the day after the experimental session. A battery of measures (mood, anxiety, quality of life, mystical experience, spiritual wellbeing, attitudes towards death, personality traits, holistic health and wellbeing, connectedness, demoralisation, expectations, qualitative data and safety measures) will be assessed at baseline and through to the end of the protocol. Participants will be followed up until either 12 months post-randomisation or death, whichever occurs first.
CONCLUSIONS: This study will examine the effect of MDMA-assisted therapy on symptoms of anxiety and depression in advanced-stage cancer. Potential therapeutic implications include establishing the safety and effectiveness of a novel treatment that may relieve mental suffering in patients with life-threatening illness.
BACKGROUND: Trial registered on Australian New Zealand Clinical Trials Registry.
BACKGROUND: ACTRN12619001334190p. Date registered: 30/09/2019. URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378153&showOriginal=true&isReview=true.
METHODS: Up to 32 participants with advanced-stage cancer and associated depression and anxiety will be randomised in a 1:1 ratio into one of two blinded parallel treatment arms. The intervention group will receive 120 mg (+ 60 mg optional supplemental dose) MDMA-assisted therapy. The psychoactive control group will receive 20 mg oral (+ 10 mg optional supplemental dose) methylphenidate-assisted therapy. For each medication-assisted therapy session, participants will undergo two 90-min therapeutic support sessions in the week preceding, and one 90-min support session the day after the experimental session. A battery of measures (mood, anxiety, quality of life, mystical experience, spiritual wellbeing, attitudes towards death, personality traits, holistic health and wellbeing, connectedness, demoralisation, expectations, qualitative data and safety measures) will be assessed at baseline and through to the end of the protocol. Participants will be followed up until either 12 months post-randomisation or death, whichever occurs first.
CONCLUSIONS: This study will examine the effect of MDMA-assisted therapy on symptoms of anxiety and depression in advanced-stage cancer. Potential therapeutic implications include establishing the safety and effectiveness of a novel treatment that may relieve mental suffering in patients with life-threatening illness.
BACKGROUND: Trial registered on Australian New Zealand Clinical Trials Registry.
BACKGROUND: ACTRN12619001334190p. Date registered: 30/09/2019. URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378153&showOriginal=true&isReview=true.
摘要：
背景：焦虑和抑郁症的症状在绝症患者中很常见，并且在该人群中，及时有效的护理存在多种挑战。几个中心报告说，一剂5-羟色胺能迷幻药psilocybin，结合治疗支持，在该患者组中，这些症状可改善长达6个月。借鉴相关的治疗机制，3,4-亚甲二氧基甲基苯丙胺（MDMA）辅助治疗可能具有实现类似，积极的心理健康结果在这个群体。初步证据还支持MDMA辅助治疗晚期癌症焦虑和抑郁的耐受性。
方法：多达32名患有晚期癌症和相关抑郁和焦虑的参与者将以1:1的比例随机分为两个双盲平行治疗组之一。干预组将接受120mg（+60mg可选的补充剂量）MDMA辅助治疗。精神活性对照组将接受20mg口服(+10mg任选补充剂量)哌醋甲酯辅助治疗。对于每个药物辅助治疗疗程，参与者将在前一周接受两次90分钟的治疗支持会议，和一个90分钟的支持会议的第二天实验会议。一系列措施(情绪，焦虑,生活质量,神秘的体验,精神健康，对死亡的态度，人格特质，整体健康和福祉，连通性，士气低落,期望,定性数据和安全措施）将在基线时进行评估，直到方案结束。参与者将接受随访，直到随机化后12个月或死亡，以先发生者为准。
结论：本研究将研究MDMA辅助治疗对晚期癌症患者焦虑和抑郁症状的影响。潜在的治疗意义包括建立一种新疗法的安全性和有效性，该疗法可以减轻危及生命的疾病患者的精神痛苦。
背景：试验在澳大利亚新西兰临床试验注册中心注册。
背景：ACTRN12619001334190p.注册日期：2019年9月30日。URL：https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378153&showOriginal=true&isReview=true。
方法：多达32名患有晚期癌症和相关抑郁和焦虑的参与者将以1:1的比例随机分为两个双盲平行治疗组之一。干预组将接受120mg（+60mg可选的补充剂量）MDMA辅助治疗。精神活性对照组将接受20mg口服(+10mg任选补充剂量)哌醋甲酯辅助治疗。对于每个药物辅助治疗疗程，参与者将在前一周接受两次90分钟的治疗支持会议，和一个90分钟的支持会议的第二天实验会议。一系列措施(情绪，焦虑,生活质量,神秘的体验,精神健康，对死亡的态度，人格特质，整体健康和福祉，连通性，士气低落,期望,定性数据和安全措施）将在基线时进行评估，直到方案结束。参与者将接受随访，直到随机化后12个月或死亡，以先发生者为准。
结论：本研究将研究MDMA辅助治疗对晚期癌症患者焦虑和抑郁症状的影响。潜在的治疗意义包括建立一种新疗法的安全性和有效性，该疗法可以减轻危及生命的疾病患者的精神痛苦。
背景：试验在澳大利亚新西兰临床试验注册中心注册。
背景：ACTRN12619001334190p.注册日期：2019年9月30日。URL：https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378153&showOriginal=true&isReview=true。
