Phase 2 Psilocybin Therapy Trial For Patients With Treatment-Resistant PTSD: Latest Findings
Phase 2 Psilocybin Therapy Trial For Patients With Treatment-Resistant PTSD: Latest Findings
Cannabis company Creso Pharma (OTC:COPHF)'s wholly-owned psychedelics subsidiary Halucenex Life Sciences Inc. shared promising early findings on its ongoing Phase 2 clinical trial assessing the efficacy of psilocybin on treatment-resistant PTSD.
大麻公司克雷索製藥(場外交易代碼：COPHF)的全資子公司迷幻藥Halucenex生命科學公司分享了其正在進行的第二階段臨床試驗中有希望的早期發現，該試驗評估了裸蓋菇素對耐藥PTSD的療效。
The single-arm, open-lab study tests the efficacy of Halucenex's synthetic psilocybin aqueous solution, Lucenex, in both 10mg and 25mg formats on severe PTSD symptoms of 20 patients.
這項單臂開放實驗室研究測試了Halucenex合成裸蓋菇素水溶液Lucenex 10 mg和25 mg兩種形式對20名患者嚴重PTSD癥狀的療效。
The psychedelic is being administered in separate sessions in a microdose and macro dose format.
迷幻劑以微劑量和大劑量的形式在單獨的療程中給藥。
Severe PTSD symptoms measured are depression and anxiety. Other measures include sleep time, addiction severity, suicidal ideation, general psychological symptoms such as pain and interpersonal relationships, overall functioning, work capacity, and physiological measures such as weight and blood pressure.
嚴重的創傷後應激障礙癥狀包括抑鬱和焦慮。其他衡量標準包括睡眠時間、成癮嚴重程度、自殺意念、疼痛和人際關係等一般心理癥狀、整體功能、工作能力以及體重和血壓等生理指標。
Of the total participants, two patients to date have received both 10mg and 25mg subsequent doses, presenting no adverse effects and further highlighting particularly promising results: two doses of psilocybin, spread one week apart, lead to a marked decrease (40% after the first dose) in symptoms presented within severe, treatment-resistant PTSD.
在所有參與者中，到目前為止，有兩名患者接受了10 mg和25 mg的後續劑量，沒有出現不良反應，進一步突出了特別有希望的結果：兩次劑量的裸蓋菇素，間隔一週，導致嚴重的、耐藥的PTSD的癥狀顯著減少(第一次劑量後40%)。
Further, the second, macro-dose resulted in immediate decrease and full remission (av. 95%) in symptoms associated with PTSD: the patients presented zero symptoms of PTSD at one month post-macro dose, and a further 75% reduction of symptoms at three-months
此外，第二次大劑量治療導致立即減少和完全緩解(av.95%)與創傷後應激障礙相關的癥狀：患者在服用宏觀劑量後一個月沒有出現創傷後應激障礙癥狀，三個月後癥狀進一步減輕75%
Specifically, severe depression symptoms were abruptly discontinued after the macrodose, sustaining their remission into month three. Severe anxiety was reduced 50% immediately following macrodose in one case and 100% in the other, and month threes after still presented minimal, or remission scores.
具體地說，嚴重的抑鬱症狀在大劑量後突然停止，持續緩解到第三個月。嚴重焦慮在大劑量後立即減少了50%，在另一個病例中是100%，三個月後仍然表現出最低或緩解評分。
Other outcomes include notable improvements in total sleep time, reduced cravings and need for THC during daytime and for sleep, significant improvements in blood pressure and social improvement with interpersonal relationships, all through the three months post-macrodose.
其他結果包括總睡眠時間顯著改善，白天和睡眠時對THC的渴望和需求減少，血壓顯著改善，人際關係改善，所有這些都是在大劑量服藥後的三個月內完成的。
The outcomes have led Halucenex to apply for a Clinical Trial Amendment (CTA) with Health Canada to streamline the clinical trial process, de-risk attrition rates and mitigate scheduling stressors for participants.
結果導致Halucenex與加拿大衛生部申請了臨床試驗修正案(CTA)，以簡化臨床試驗流程，降低風險流失率，並緩解參與者的日程安排壓力。
The amendments were approved on April 26 and include a larger window for pre-screening, the ability of the company's CSO to prepare doses without the need for a compounding pharmacist, and the possibility to spread each patient's seventh visit over 1-3 days.
修正案於4月26日獲得批准，包括更大的預篩查窗口，該公司的CSO能夠在不需要復合藥劑師的情況下準備劑量，以及可能將每個患者的第七次就診時間分散在1-3天內。
Pending the amendment's outcome, Halucenex still aims to administer the psychedelic to a weekly average of two patients and expects trial completion by the third quarter of 2023.
在修正案公佈結果之前，Halucenex的目標仍然是每週平均給兩名患者服用迷幻劑，預計試驗將於2023年第三季度完成。
Photo: Benzinga edit with photo by YAKOBCHUK VIACHESLAV and Alexander_Volkov on Shutterstock.
圖片：Benzinga編輯與YAKOBCHUK Viacheslav和Alexander_Volkov在Shutterstock上的照片。
譯文內容由第三人軟體翻譯。