AUSTIN, Texas--(BUSINESS WIRE)--SÄPT today shared new data, presented by researchers this weekend, which showed that long-term efficacy was maintained for almost 2 years among adult patients participating in the LSD-Assist Study that investigated the efficacy and safety of LSD in the treatment of anxiety..

德克萨斯州奥斯汀--（商业新闻短讯）--SÄPT今天分享了研究人员本周末提供的新数据，该数据显示，参与LSD辅助研究的成年患者的长期疗效维持了近2年，该研究调查了LSD治疗焦虑症的有效性和安全性。。

Data presented at the annual meeting of the SOBP in Austin, Texas, demonstrated that 1 year after the conclusion of the 50-week-long placebo-controlled period of the LSD-Assist Study, participants’ scores on the clinically validated State-Trait Anxiety Inventory–Global (STAI-G), showed that remission rates remained the same – 32% at week 50 vs.

在德克萨斯州奥斯汀举行的SOBP年会上提供的数据表明，在LSD Assist研究的50周安慰剂对照期结束后1年，参与者在临床验证的状态-特质焦虑量表-全球（STAI-G）上的得分显示，缓解率保持不变，第50周为32%。

33% at week 102..

第102周为33%。。

“The statistically significant, rapid, strong and long-lasting reductions in STAI-G scores, combined with similarly sustained responses in all secondary endpoints are extremely encouraging,” said Friederike Holze PhD, UHB, who presented the study. “While LSD has shown beneficial effects on reducing anxiety, there has still been a need for a deeper understanding of its long-lasting effects and safety.

UHB的Friederike Holze博士介绍了这项研究，他说：“STAI-G评分在统计学上显着，快速，强烈和持久的下降，加上所有次要终点的类似持续反应，非常令人鼓舞。”。“虽然迷幻剂已显示出对减轻焦虑的有益作用，但仍需要对其持久作用和安全性有更深入的了解。

This is why we designed a robust, randomized, double-blind placebo-controlled clinical trial with a pre-planned long-term follow-up period.”.

这就是为什么我们设计了一个强大的，随机的，双盲的安慰剂对照临床试验，并有预先计划的长期随访期。”。

In the 50-week placebo-controlled period of the LSD-Assist study, the primary endpoint was achieved with LSD treatment resulting in statistically significant and robust reductions of STAI-G scores 16 weeks after treatment in the between-subjects analysis (least square mean (± SE) change from baseline difference = -16.2 (5.8), 95% CI=-27.8 to -4.5, p=0.007).

在LSD辅助研究的50周安慰剂对照期间，主要终点是通过LSD治疗实现的，导致受试者间分析中治疗16周后STAI-G评分的统计学显着和稳健降低（最小二乘平均值（±SE）从基线差异变化=-16.2（5.8），95%CI=-27.8至-4.5，p=0.007）。

Effects were maximal 2 weeks after the second LSD session and sustained throughout the study..

在第二次LSD治疗后2周，效果最大，并在整个研究过程中持续存在。。

Acute positive effects or mystical experiences significantly correlated with long-term therapeutic outcomes at 16 weeks. LSD was well-tolerated, with only one SAE that was considered related to treatment, which consisted of acute transient anxiety and delusions during an LSD session with a positive outcome for the patient.

急性积极影响或神秘体验与16周时的长期治疗结果显着相关。LSD耐受性良好，只有一种SAE被认为与治疗有关，包括LSD治疗期间的急性短暂性焦虑和妄想，对患者有积极的结果。

There were no recorded instances of treatment-emergent suicidal ideation with intent, suicidal behavior, or intentional self-injury..

没有记录在案的治疗紧急自杀意念，包括意图，自杀行为或故意自伤。。

About the LSD-Assist Study

关于LSD辅助研究

This investigator-initiated, two-center, clinical trial was a double-blind, placebo-controlled, cross-over trial that investigated the safety and efficacy of LSD for the treatment of anxiety. The trial enrolled 46 patients either suffering from anxiety symptoms with life-threatening illnesses or with an anxiety disorder without severe somatic illness.

这项由研究者发起的双中心临床试验是一项双盲，安慰剂对照，交叉试验，研究了LSD治疗焦虑症的安全性和有效性。该试验招募了46名患有威胁生命的疾病的焦虑症状或没有严重躯体疾病的焦虑症患者。

Patients were randomly assigned to two sessions, separated by 6 weeks, with either oral LSD (200 μg) or placebo administration in the first period and vice versa after the cross-over in the second period and were initially followed for 50 weeks..

患者被随机分配到两个疗程，间隔6周，第一阶段口服LSD（200μg）或安慰剂，第二阶段交叉后反之亦然，最初随访50周。。

The primary efficacy endpoint was the reduction in anxiety symptoms 16 weeks after the second LSD or placebo administration in the first period. The primary outcome measure was the State-Trait Anxiety Inventory (STAI) global score, which is used to assess the severity of anxiety symptoms. Secondary outcome measures included improvements in Hamilton Depression Scale (HAM-D-21), Beck Depression Index (BDI), and several other major psychiatric symptoms (Symptom-Check-List-90-R) scores.

主要疗效终点是第一阶段第二次LSD或安慰剂给药后16周焦虑症状的减轻。主要结局指标是状态-特质焦虑量表（STAI）全球评分，用于评估焦虑症状的严重程度。次要结局指标包括汉密尔顿抑郁量表（HAM-D-21），贝克抑郁指数（BDI）和其他几种主要精神症状（Symptom-Check-List-90-R）评分的改善。

For additional information on this trial see clinicaltrials.gov [NCT03153579]..

有关该试验的更多信息，请参阅clinicaltrials.gov[NCT03153579]。。

Long-term Follow-up from LSD-Assist

LSD Assist的长期随访

The long-term data presented at SOBP were based upon an a priori-planned long-term follow-up designed to help understand the long-term impact of LSD on participants’ anxiety. Participants were contacted 52 weeks after their last visit from the placebo-controlled study for assessments utilizing the same validated questionnaires administered in previous study visits.

SOBP提供的长期数据是基于先验计划的长期随访，旨在帮助了解LSD对参与者焦虑的长期影响。在安慰剂对照研究的最后一次访问后52周，参与者被联系起来，使用之前研究访问中使用的相同验证问卷进行评估。

This study revealed potential long-lasting benefits from LSD in patients with anxiety, showing sustained improvements in anxiety (STAI-G scores) 12 months post-study with no additional adverse effects reported..

这项研究揭示了LSD对焦虑患者的潜在长期益处，显示研究后12个月焦虑（STAI-G评分）持续改善，没有其他不良反应报告。。

'We are pleased to see the results from this study persist for the participants in this trial one year after its placebo-controlled portion concluded and are encouraged that they continue to benefit from their treatment,” added Peter Gasser, MD, co-investigator of the study and President of SÄPT. “Dr.

“我们很高兴看到这项研究的结果在安慰剂对照部分结束一年后持续存在，并鼓励他们继续从治疗中受益，”该研究的联合研究员兼SÄPT总裁Peter Gasser医学博士补充道。“博士。

Holze and I feel honored to receive SOBP’s Somerfeld-Ziskind award and thank all the patients whose long-term participation made these findings possible.”.

霍尔兹和我很荣幸获得SOBP的Somerfeld Ziskind奖，并感谢所有长期参与使这些发现成为可能的患者。”。

About SÄPT, the Swiss Medical Society for Psychedelic Treatment

关于瑞士迷幻剂治疗医学会SÄPT

The Swiss Medical Association for Psycholytic (Psychedelic) Therapy was founded in 1985 and has now developed into a specialist society with around 210 members, primarily from Switzerland and Germany. Its statutory purpose is to make psychoactive substances accessible for practical psychotherapeutic use, to control their handling, to stimulate further research and to offer the theoretical and practical training necessary for their handling..

瑞士心理（迷幻）治疗医学协会成立于1985年，现已发展成为一个拥有约210名成员的专业协会，主要来自瑞士和德国。其法定目的是使精神活性物质可用于实际的心理治疗用途，控制其处理，刺激进一步的研究，并为其处理提供必要的理论和实践培训。。

From 1988 to 1993, five SÄPT therapists received an exemption from the Swiss Federal Office of Public Health (BAG) to carry out psychedelic treatment with the substances MDMA and LSD in their practices. During these five years, about 170 patients were treated, undergoing just over a thousand full-day sessions, and the results were published in 1996.

从1988年到1993年，五名SÄPT治疗师获得了瑞士联邦公共卫生局（BAG）的豁免，在他们的实践中使用MDMA和LSD物质进行迷幻治疗。在这五年中，约有170名患者接受了治疗，接受了1000多次全天治疗，结果于1996年公布。

Since then, SÄPT has conducted or co-sponsored numerous studies and initiated the limited-use program, which has given around 60 therapists the opportunity to treat several hundred patients with psychedelic substances under individual licenses over the last ten years. SÄPT has been led by Dr. Gasser since 1997..

从那时起，SÄPT进行或共同赞助了许多研究，并启动了有限使用计划，该计划在过去十年中为大约60名治疗师提供了根据个人许可证治疗数百名迷幻药物患者的机会。自1997年以来，SÄPT一直由Gasser博士领导。。