LSD Microdosing For PMS? After Confirming Antidepressant Effects, Clinical Trials Will Assess If It Addresses Mood Issues
LSD Microdosing For PMS? After Confirming Antidepressant Effects, Clinical Trials Will Assess If It Addresses Mood Issues
The Australian-based biopharma company MindBio Therapeutics Corp. (CSE:MBIO) obtained regulatory approval for a series of clinical trials in women's health using its proprietary LSD drug, MB22001. The company said it is the only one in the world with regulatory approvals of the take-home use of this type of scheduled drug in clinical trials.
總部位於澳大利亞的生物製藥公司MindBio Therapeutics Corp.（CSE: MBIO）使用其專有的迷幻藥物 MB22001 進行一系列女性健康臨床試驗獲得了監管部門的批准。該公司表示，這是世界上唯一一家獲得監管部門批准在臨床試驗中將此類附表藥物帶回家的公司。
MB22001 is designed for take-home self-administration by patients. The company's thesis is that it can be used acutely during specific periods of the menstrual cycle, with targeted dosing to treat negative mood symptoms. This thesis is based on three main facts a) The acute dose day mood-elevating effects of MB22001 have been demonstrated in MindBio's Phase 1 trials b) MindBio's Phase 2a open-label trial in depressed patients show long-term improvements in mood and c) reports in the grey literature of people self-medicating for PMS/PMDD using LSD microdoses.
MB22001 專爲患者自給藥而設計。該公司的論點是，它可以在月經週期的特定時期急性使用，有針對性的劑量治療負面情緒症狀。本論文基於三個主要事實 a) MindBio的1期試驗證實了MB22001 的急性劑量日情緒提升作用 b) MindBio針對抑鬱症患者的2a期開放標籤試驗顯示情緒長期改善，c) 灰色文獻中有關於人們使用迷幻藥微劑量自我藥物治療PMS/PMDD的報道。
The Two Trials Approved
兩項試驗獲得批准
Premenstrual syndrome (PMS) is estimated to affect ~25% of all women who menstruate – equivalent to 956 million women worldwide. A particularly severe form of PMS is termed premenstrual dysphoric disorder (PMDD) which affects 3-8% of women who menstruate.
據估計，經前綜合症（PMS）影響到所有月經女性的約25％，相當於全球9.56億女性。一種特別嚴重的經前綜合徵被稱爲經前焦慮症（PMDD），其影響3-8％的月經期女性。
Current treatments for these issues are selective serotonin reuptake inhibitors (SSRIs), given either continuously or daily during the luteal phase of the menstrual cycle. While SSRIs can be effective for some with PMDD approximately 40% of women with PMDD do not respond to SSRIs, and common side effects of SSRIs when used for PMDD include nausea, decreased energy, somnolence, fatigue, decreased libido and sweating.
目前針對這些問題的治療方法是選擇性血清素再攝取抑制劑（SSRI），在月經週期的黃體期持續或每天給藥。儘管SSRI對一些PMDD患者可能有效，但大約40％的PMDD女性對SSRI沒有反應，而SSRI在用於PMDD時常見的副作用包括噁心、精力下降、嗜睡、疲勞、性慾下降和出汗。
MindBio obtained approvals for two women's health trials:
MindBio獲得了兩項女性健康試驗的批准：
- An open-label trial to test menstrual cycle effects and tolerance to MB22001 microdosing in healthy people with a menstrual cycle (MDMENS).
- 一項開放標籤試驗，旨在測試有月經週期的健康人群（MDMENS）的月經週期影響和對 MB22001 微劑量的耐受性。
- The MDPMD trial is a randomized, double-blind, placebo-controlled, parallel groups, trial of MB22001 microdosing in persons with Premenstrual Syndrome (PMS)/Premenstrual Dysphoric Disorder (PMDD).
- MDPMD 試驗是一項隨機、雙盲、安慰劑對照的平行組試驗，針對經前綜合症 (PMS) /經前焦慮症 (PMDD) 患者 MB22001 微劑量。
The research team for MindBio's women's health trials includes leading menstrual cycle researchers from three continents. To the company's knowledge, MDMENS will be the first study to investigate the response to psychedelics across the menstrual cycle.
MindBio女性健康試驗的研究團隊包括來自三大洲的領先月經週期研究人員。據該公司所知，MDMENS將是第一項調查整個月經週期中迷幻藥反應的研究。
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Photo: Courtesy of Andre Furtado via Unsplash
照片：由 Andre Furtado 通過 Unsplash 提供
譯文內容由第三人軟體翻譯。