Background: Terminally ill patients often experience significant psychosocial distress having depressed mood, death anxiety, pain, and an overall poor quality of life. Recent evidence from pilot studies suggests that serotonergic hallucinogens including lysergic acid diethylamide (LSD) and psilocybin produce significant and sustained reductions of depressive symptoms and anxiety, along with increases in quality of life, and life meaning in patients suffering from life-threatening diseases. Additionally, serotonergic hallucinogens may produce antinociceptive effects.
Objective and Design: The study aims to evaluate effects of LSD on psychosocial distress in 60 patients suffering from an end-stage fatal disease with a life expectancy ≥12wks and ≤2yrs in an active placebo-controlled double-blind parallel study. Patients will be allocated in a 2:1 ratio to one of the two intervention arms receiving either two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of LSD (25 µg and 25 µg) as active-placebo control.

Start Date11 Jun 2024

Sponsor / Collaborator

Universitätsspital Basel

[+1]

NCT05474989 / Not yet recruitingPhase 2IIT

LSD Treatment for Persons With Alcohol Use Disorder: A Multicenter, Double-blind, Randomized, Active-placebo Controlled Phase II Study

Alcohol use causes more overall harm than any other drug and is the seventh leading risk factor for both deaths and disability-adjusted life years. Alcohol use disorders (AUD) are among the most common and undertreated mental disorders in developed countries. Pharmacological and psychotherapeutic treatments only show limited efficacy and around 60% of the patients relapse in the short-term after withdrawal.
Lysergic acid diethylamide (LSD) was investigated in numerous clinical trials during the 1950s and 1960s. Specifically, the use of LSD in the treatment of AUD was investigated extensively. A pooled analysis of six historical clinical trials demonstrated, that a single dose of LSD significantly reduced alcohol use at three and six months after LSD administration. However, these trials are limited by several factors, including the use of diagnostic standards that are no longer not up to date, single, high-dose treatment regimes, missing biological assessment for alcohol use, and no consequent assessment of blinding.
Therefore, the present study aims to evaluate the safety and efficacy of LSD for the treatment of AUD and addresses the shortcomings of previous studies. The trial has a double-blind, active placebo-controlled, randomized, parallel design and will be conducted in specialized treatment centers for addictive disorders in Switzerland. The study will include 126 patients after withdrawal treatment and will primarily assess the efficacy of LSD for the treatment of AUD. Patients will be treated using a 1:1 allocation. Each arm will last 20 weeks and will comprise nine study visits without drug administration and two study days involving LSD or active placebo administration. In the first session, patients in the treatment group will receive a dose of 150 µg LSD, followed by another 150 µg or 250 µg LSD in the second session, which will take place approximately 4 weeks after the first session.
The primary outcome is the mean of percent heavy drinking days after administration of two doses of LSD at 3 months follow-up. Additionally, the study will assess neurobiological mechanisms of action and several other measures.

Start Date01 Jun 2024

Sponsor / Collaborator

Universitätsspital Basel

[+1]

100 Clinical Results associated with Lysergic acid diethylamide

100 Translational Medicine associated with Lysergic acid diethylamide

100 Patents (Medical) associated with Lysergic acid diethylamide

5,254

Literatures (Medical) associated with Lysergic acid diethylamide

01 Jan 2025·FOOD CHEMISTRY

The possible inhibition mechanism of low salt dry-curing on volatile flavor deterioration in refrigerated grass carp (Ctenopharyngodon idella) blocks: Metabolomics and microorganisms

Article

Author: Peng, Bin ; Hu, Mingming ; Li, Jinlin ; Tu, Zongcai ; Yu, Chengwei ; Xu, Linju ; Zhong, Bizhen

Complex microbial communities have an important impact on the flavor of low salt dry-curing (LSD)-pretreated grass carp blocks. Here, the flavors, metabolites, and bacterial diversity of LSD-pretreated fish during cold storage were analyzed using flavor analysis, metabolomics, and high-throughput sequencing to investigate their correlations in detail. LSD promoted the volatile flavor deterioration of grass carp blocks under 6 days of refrigeration but inhibited it under 15 days of refrigeration. Furthermore, 924 metabolites were identified in the refrigerated grass carp blocks, and LSD inhibited the growth of Psychrophilic dominant spoilage microorganisms (Proteobacteria) and promoted microbial abundance (Actinobacteriota, Firmicutes, Bacteroidota, and Cyanobacteria). Correlation analysis revealed that the degradation of phosphatidylcholine connected with the monomonas genus in LSD-pretreated fish blocks played a vital role in inhibiting the key volatile flavor (esters, aldehydes, and alcohols) deterioration. This information is useful for elucidating the inhibition mechanism of LSD on flavor deterioration in refrigerated fish blocks.

01 Jan 2025·JOURNAL OF AFFECTIVE DISORDERS

The association between study design and antidepressant effects in psychedelic-assisted therapy: A meta-analysis

Review

Author: Liang, Chih-Sung ; Li, Jia-Ru ; Yang, Fu-Chi ; Kao, Yu-Chen ; Hsu, Tien-Wei ; Chiang, Kuo-Tung ; Yu, Chia-Ling

Different study designs of psychedelic trials may impact the blinding and expectance, leading to biased treatment effects. This study aimed to examine the association between antidepressant efficacy and study designs in psychedelic trials. Six databases were systematically searched. Eligible trials were required to investigate the efficacy of psychedelics (psilocybin, lysergic acid diethylamide [LSD], 3,4-Methylenedioxymethamphetamine [MDMA], and ayahuasca) in adult patients with depressive symptoms. We only considered oral psychedelic-assisted therapy without concomitant use of antidepressants. The primary outcome was the change in depressive symptoms. There were five study designs of psychedelic trials, including non-active-drug-as-placebo, active-drug-as-placebo, waitlist-as-control, fixed-order, and pre-post designs. In non-active-drug -as-placebo design, psilocybin (k = 4, Hedges' g [g] = 0.87, 95 % confidence intervals[CIs] = 0.58 to 1.16) and MDMA (k = 2, g = 0.65, 95%CIs = 0.26 to 1.05) were associated with large and medium effect sizes, respectively. In active-drug-as-placebo design, both psilocybin (k = 2, g = 0.71, 95%CIs = -0.01 to 1.43) and MDMA (k = 3, g = 0.53, 95%CIs = -0.23 to 1.28) were not statistically significant. In pre-post single-arm (k = 3, g = 2.51, 95%CIs = 1.00 to 4.02) and waitlist-as-control (k = 1, g = 2.88, 95%CIs = 1.75 to 4.00) designs, psilocybin showed a large effect size of antidepressant effect. Ayahuasca also showed a large effect size in both pre-post (k = 2, g = 1.88, 95%CIs = 1.18 to 2.57) and non-active-drug-as-placebo (k = 1, g = 1.60, 95%CIs = 0.84 to 2.36) designs. LSD was associated with a significant antidepressant effect only in non-active-drug-as-placebo design (k = 1, g = 1.49, 95%CIs = 0.80 to 2.17) but not in active-drug-as-placebo design (k = 1, g = 0.44, 95%CIs = -0.90 to 1.78). The antidepressant effects of psychedelics may be overestimated in studies with pre-post single-arm, non-active-drugs-as placebo, and waitlist-control designs. Restricted sample size, difficulty with establishing blinding for participants, and over expectancy limit the estimation of the antidepressant effect of psychedelic-assisted therapy.

01 Jan 2025·PROGRESS IN NEURO-PSYCHOPHARMACOLOGY & BIOLOGICAL PSYCHIATRY

Psychedelic-related deaths in England, Wales and Northern Ireland (1997–2022)

Article

Author: Penttinen, Jenni ; Kopra, Emma I. ; Copeland, Caroline S. ; Copeland, Caroline S ; Kopra, Emma I ; Rucker, James J ; Rucker, James J.

BACKGROUND:

Psychedelic drugs are increasingly visible in society once more, but their risks and adverse effects have received less attention than perhaps they should. While fatalities associated with psychedelics appear rare, a systematic approach to characterising their aetiology is required to inform harm minimisation efforts.

AIMS:

This study aimed to analyse prevalence and characteristics of psychedelic-related deaths in England, Wales, and Northern Ireland, between 1997 and 2022.

METHODS:

We analysed coroner reports submitted to the National Programme on Substance Use Mortality where psychedelic serotonergic agonist drugs were involved in the death, and conducted a thematic framework analysis to explore potential factors associated with their occurrence.

RESULTS:

We identified 28 cases where psychedelics were implicated (75 %, N = 21) or potentially implicated (25 %, N = 7) in the death; 19 of these involving psychedelic tryptamines (LSD 39 %, N = 11; Psilocybin 21 %, N = 6; DMT 7 %, N = 2), and 9 psychedelic phenethylamines (incl. NBOMes 18 %, N = 5). Most deaths were deemed accidental by the coroner (86 %, N = 24), including both traumatic injuries and drug toxicities; most cases involved multiple implicated drugs (68 %, N = 19); and most of the deceased were under 30 years of age (82 %, N = 23). Thematic framework analysis identified nine themes in the deaths across three categories. 'Polysubstance use' was the most common theme (82 % of cases, N = 23/28), followed by a suboptimal 'physical environment' (70 % of cases where this information was available, N = 14/20).

CONCLUSIONS:

The profound and often unpredictable effects of psychedelics pose a unique profile of risks and adverse reactions. Nevertheless, psychedelic-related deaths remain very rare in comparison to other recreational drugs, and frequently involve polydrug use. Implications for harm reduction and policy are discussed.

158

News (Medical) associated with Lysergic acid diethylamide

16 Oct 2024

·www.globenewswire.com

Firefly Neuroscience Collaborates with Bright Minds Biosciences to Analyze the Data from its Positive Phase 1 Study using its Artificial Intelligence, FDA-Cleared BNA™ Technology

During the Phase 1 study, subjects utilized EEG headsets provided by Firefly partner, Zeto, after which the data was analyzed using Firefly’s advanced AI BNA technology analysis platformTORONTO, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly,” or the “Company”) (NASDAQ: AIFF), an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, today announced collaborating with Bright Minds Biosciences Inc. (CSE:DRUG) (NASDAQ:DRUG) (“Bright Minds” or the “Company”), a biotechnology company focused on developing novel drugs for the targeted treatment of neuropsychiatric disorders and refractory epilepsy, to analyze the data from its first-in-human Phase 1 study of its lead compound, BMB-101. The study demonstrated positive results of the qEEG (Quantitative Electroencephalogram) data. During the EEG recording, subjects were seated with a U.S. Food and Drug Administration (FDA)- approved 19 electrode EEG headset provided by Firefly strategic partner, Zeto™ Inc. Channels were sampled at 250 or 500 Hz and referenced to A1/A2 channels (linked-ears reference) during recording. The EEG recording time was 10 minutes (~5 minutes resting with eyes closed and ~5 minutes resting with eyes open). There were four EEG recording timepoints: day 1 pre-dose (immediately before dosing) and post-dose (1h after dosing), and day 7 pre-dose and post-dose. Data was analyzed using the FireFly Neuroscience advanced EEG analysis platform. “Our artificial intelligence platform has tremendous value for the advancement and insight of clinical studies,” said Jon Olsen, CEO of Firefly. “We are pleased to have successfully collaborated with Bright Minds to analyze the data of their phase 1 study and look forward to working closely with their team once again as well as other leading biotechnology companies.” “The positive topline findings from our recently completed Phase 1 study of BMB-101, together with the observations from the qEEG portion of the study, validate our approach, as we continue to evaluate this important product candidate. BMB-101 is clearly [getting into the brain/achieving brain penetration] and activating the target receptors as we had predicted, setting us up for potential success in a number of indications that have been validated with the 5-HT2C mechanism. With this study complete, BMB-101 is now a Phase 2 ready asset, and we intend to move forward with an investigative new drug submission immediately,” stated Ian McDonald, CEO of Bright Minds. About FireflyFirefly (NASDAQ: AIFF) is an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders. Firefly’s FDA-510(k) cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has built a comprehensive database of brain wave tests, securing patent protection, and achieving FDA clearance. The Company is now launching BNA™ commercially, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for clinical use. Brain Network Analytics was developed using artificial intelligence and machine learning on Firefly’s extensive proprietary database of standardized, high-definition longitudinal electroencephalograms (EEGs) of over 17,000 patients representing twelve disorders, as well as clinically normal patients. BNA™, in conjunction with an FDA-cleared EEG system, can provide clinicians with comprehensive insights into brain function. These insights can enhance a clinician’s ability to accurately diagnose mental and cognitive disorders and to evaluate what therapy and/or drug is best suited to optimize a patient’s outcome. Please visit https://fireflyneuro.com/ for more information. About BMB-101BMB-101, a highly selective 5-HT2C, Gq-protein biased agonist, has demonstrated compelling activity in a host of in vitro and in vivo nonclinical tests. Compared to Lorcaserin, BMB-101 exhibits strong Gq biased signaling, coupled with minimal beta-arrestin recruitment. Bright Minds believes that G-protein biased signaling translates to better tolerance profile for this second-generation 5-HT2C agonist, making BMB-101 a best-in-class 5-HT2C agonist. Mechanistically, Serotonin (5-Hydroxytryptamine, 5-HT) is a monoamine neurotransmitter widely expressed in the central nervous system, and drugs modulating 5-HT have made a major impact in mental health disorders. Central 5-HT systems have long been associated with the control of ingestive behaviors and the modulation of the behavioral effects of psychostimulants, opioids, alcohol, and nicotine. Results of clinical trials and animal studies indicate that 5-HT2C receptor agonists may have therapeutic potential in the treatment of addiction by decreasing the intake of opioids as well as impulsive behavior that can escalate compulsive drug use. BMB-101 is a new chemical entity (NCE) and constitutes a novel scaffold 5-HT2C agonist. 5-HT2C agonism is a well proven anticonvulsant mechanism. In translational animal models, BMB-101 demonstrated a significant reduction in both the number and intensity of epileptic seizures and is a promising candidate for the treatment of Dravet Syndrome and other epilepsies. The Phase 1 trial (NCT 05397041) has been completed and BMB-101 is now Phase 2 ready. About Bright MindsBright Minds is focused on developing novel transformative treatments for neuropsychiatric disorders, epilepsy, and pain. Bright Minds has a portfolio of next-generation serotonin agonists designed to target neurocircuit abnormalities that are responsible for difficult to treat disorders such as treatment resistant epilepsy, treatment resistant depression, PTSD, and pain. The Company leverages its world-class scientific and drug development expertise to bring forward the next generation of safe and efficacious drugs. Bright Minds’ drugs have been designed to potentially retain the powerful therapeutic aspects of psychedelic and other serotonergic compounds, while minimizing the side effects, thereby creating superior drugs to first-generation compounds, such as fenfluramine, psilocybin, LSD, and ibogaine. Forward-Looking StatementsCertain statements in this press release and the information incorporated herein by reference may constitute “forward-looking statements” for purposes of the federal securities laws concerning Firefly. These forward-looking statements include express or implied statements relating to Firefly’s management teams’ expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Firefly will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Firefly’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to development and commercialization of BNA™ technology; risks related to Firefly’s ability to recognize the anticipated benefits of the merger (the “Merger”) with WaveDancer, Inc. (“WaveDancer”); risks related to Firefly’s ability to correctly estimate its operating expenses and expenses associated with the Merger and other events and unanticipated spending and costs that could reduce Firefly’s cash resources; the ability of Firefly to protect its intellectual property rights; competitive responses to the business combination; unexpected costs, charges or expenses resulting from the Merger; potential adverse reactions or changes to business relationships resulting from the completion of the Merger; legislative, regulatory, political and economic developments; and those factors described under the heading “Risk Factors” in the in the registration statement on Form S-4 filed by WaveDancer with the Securities and Exchange Commission on January 22, 2024, as amended, and declared effective on February 6, 2024. Should one or more of these risks or uncertainties materialize, or should any of Firefly’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. It is not possible to predict or identify all such risks. Forward-looking statements included in this press release only speak as of the date they are made, and Firefly does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Firefly Neuroscience Investor ContactsKCSA Strategic CommunicationsValter Pinto / Jack Perkins(212) 896-1254Firefly@KCSA.com Firefly Neuroscience Media ContactKCSA Strategic CommunicationsRaquel Cona, Vice President(516) 779-2630Rcona@KCSA.com

Phase 1Phase 2Clinical Result

26 Sep 2024

·endpts.com

Endpoints 11 winner Seaport Therapeutics: The Karuna team is back with another big bet in neuroscience

On Thursday, members of Seaport Therapeutics’ founding team watched from afar as their old company, Karuna Therapeutics, got its schizophrenia drug approved by the FDA. Now they plan to do it again. Seaport, with $100 million to its name when it officially launched this spring, is working on major depressive disorder, generalized anxiety, mood disorders and other neuropsychiatric conditions. It’s a tall feat in one of the hardest therapeutic areas for drug development but, if successful, could impact tens of millions of people. The new company spent the last five years inside PureTech Health, which runs a hub-and-spoke model, incubating startups and then spinning them out into separate entities. “Investors actually often prefer to invest in a focused story that is more like a traditional biotech even though these hub-and-spoke models have been very successful from an R&D perspective,” said Daphne Zohar, the former PureTech CEO and now Seaport’s chief executive. Karuna generated an approximately 59x return for PureTech when it was sold to Bristol Myers Squibb for $14 billion. With Seaport, PureTech still holds more than 50% of the company, with more backing from blue-chip biotech investors like ARCH, Sofinnova Investments and Third Rock Ventures. Its Karuna alums include Zohar and Steve Paul, a neuroscience drug veteran whose career also includes stops as a co-founder of Sage Therapeutics and a longtime researcher at Eli Lilly. Several board members from Karuna are back as well, including Sofinnova Investments’ Jim Healy, former Johnson & Johnson executive Denice Torres, and ex-AstraZeneca SVP David Wheadon. They’re betting that Seaport can be the latest high-profile story in the neurology and psychiatry drug development resurgence. It’s also a personal mission for Zohar, whose mother has anxiety and teenage daughter has depression. There’s a large unmet need — and market — for the drugs as well. “If you actually look back across depression drugs that have been approved, it’s hard to find one that hasn’t been a commercial success,” Zohar said. Combined, mood and anxiety disorders are “as large as obesity, certainly in the US,” said Paul, who serves as Seaport’s chairman. Like Karuna, Seaport is working on turning older assets into novel treatments. And like Sage’s postpartum depression medicines Zulresso and Zurzuvae, it’s working on allopregnanolone, a neurosteroid made by the hormone progesterone. It’s working on creating prodrugs of two additional compounds that have already been tested in humans. “That’s what makes me excited, that we have a relatively high probability of technical success and that the timelines will also play out in the near term,” Paul said. In “the next two, three, four years, we’ll know a lot about all three programs,” he said on the startup’s first drugs. One key part of Seaport’s technology is what it calls its Glyph platform, which it has used in the first three programs. It “cloaks” a small molecule “as if it were a dietary fat,” co-founder and chief scientific officer Michael Chen said. “Once you do that, it’s absorbed through the lymphatic system of the gut, which is this very high capacity fat-absorbing machine.” The key is that the medicine avoids the liver, otherwise the liver could “chew up 99% of the drug and leave essentially nothing for the bloodstream and nothing for the brain to take advantage of.” The startup is preparing for a potentially registration-enabling Phase 2b of the allopregnanolone prodrug, SPT-300, in major depressive disorder, Zohar said. Its second asset, a prodrug of agomelatine, is further behind and being studied for generalized anxiety disorder. The third pipeline project, for mood and neuropsychiatric disorders, goes after a “rapidly-acting antidepressant in much the same way that the psychedelic drugs are believed to work, like LSD and psilocybin, but without that trip,” Paul said. Psychiatry trials can be full of risk, and unexpected placebo results have taken down other drugs. The Seaport team is doing what it can to mitigate that. “What we want to do, obviously, is execute these trials in a way very much like we did at Karuna, where we control placebo response rates, keep them manageable, where we recruit people that really should be in the trials, not professional patients — people that don’t have inflated ratings at baseline, and then all of a sudden get better,” Paul said. And it sees neuropsychiatric conditions as, potentially, just the start. Its Glyph platform is “broadly applicable” to oncology, metabolic diseases and other therapeutic areas, Chen said. The first three assets are “sort of the tip of the iceberg we feel for a revolution in CNS,” Chen said. Key backers: ARCH Venture Partners, Sofinnova Investments, Third Rock Ventures, PureTech Health Find the full list of 2024 Endpoints 11 winners here .

AcquisitionPhase 2Drug ApprovalIPO

24 Sep 2024

·www.businesswire.com

Sermo Barometer Finds 94% of Global Mental Healthcare Professionals Are Open to Integrating Psychedelic Treatments Into Their Practices If Legalized

NEW YORK--( BUSINESS WIRE )--The 34th Barometer from Sermo , an online physician and provider community and leader in healthcare insights, surveyed 430+ mental healthcare providers around the world, including psychiatrists, general practice physicians, and advanced practice providers, on their sentiments about psychedelic and dissociative drug treatments, finding that 94% would be open to integrating these treatments into their practices if legalized in their countries. Worldwide, there has been growing interest from industry, government, media, and patients in psychedelics for the treatment of mental health conditions. 89% of HCPs surveyed believe that psychedelic medicines have unique therapeutic potential compared to traditional medications in treating patients with significant mental health conditions, such as treatment-resistant depression, post-traumatic stress disorder, and anorexia nervosa. Existing Familiarity with Psychedelics: HCPs are keeping up with developing research about psychedelics for the treatment of mental health conditions. The majority of surveyed healthcare professionals (67%) were either moderately or extensively familiar with the current clinical research on psychedelic and dissociative drugs. Surveyed psychiatrists had more familiarity (71%) with clinical research than other specialties. Ketamine is the most well-known psychedelic and dissociative drug among surveyed HCPs, with 45% indicating they are extremely or very familiar with its use in treating mental health disorders. This is followed by MDMA at 29%, LSD at 26%, and psilocybin at 25%. According to one anonymous Sermo U.S. psychiatrist and survey respondent, “ Psychedelics may have potential significant benefits but they also carry significant risks. If we are to introduce them as psychiatric treatments there needs to be research on their safety and efficacy. They need to be regulated and safety measures need to be put into place. It's important that the right patients obtain benefit and that people do not abuse them. It's important that they be medically supervised to prevent just anyone from using them. Once enough research has been done, I see them integrating into psychiatric care like esketamine, with strict measures in place.” Potential Barriers & Practice Integration: If legalized, HCPs feel there are many barriers to integrating psychedelic and dissociative drug treatments into their practices. Healthcare professionals report needing clinical guidelines (80%), comprehensive training programs (78%), and guidance to legal considerations (60%). HCPs do not view psychedelic and dissociative drugs as a first-line treatment, with nearly half (45%) of surveyed HCPs citing lack of response to traditional treatments as key criteria to prescribe psychedelic and dissociative drugs to a patient. Patients are also open to the idea of psychedelic and dissociative drug treatments. 79% of those surveyed report that they noticed increasing patient interest in psychedelics as a treatment option. When asked why they felt patients are more open, the most common answer was a growing acceptance of alternative mental health treatments (64%) and increased media coverage of psychedelics (60%). Agreement with FDA Decisions Varies by Treatment: U.S. healthcare professionals aren’t always in agreement with the FDA's decisions. Despite the recent decision not to grant MDMA approval for the treatment of PTSD, 52% of HCPs believe an exception should be made for veterans, who have spent years lobbying for the drug, to receive the treatment. However, 73% agreed with the FDA’s decision to grant LSD-based medications breakthrough status for the treatment of generalized anxiety. Two U.S. states have already decriminalized psilocybin (magic mushrooms) creating easy access for residents to purchase, possess, and grow them. While many healthcare professionals are open to the future of psychedelics to treat mental health conditions, the majority (61%) do not feel patients should be able to readily access psilocybin without medical intervention for the purposes of treating depression, addiction, and PTSD. Eye on Ketamine: 52% of surveyed HCPs believe that ketamine is being prescribed “off-label” too often. Two-thirds (67%) of surveyed HCPs believe compounding pharmacies should not be allowed to distribute Ketamine. This survey was fielded August 28th- September 4th as the 34th edition of Sermo’s ongoing Barometer study. The survey included 431 psychiatrists, general practice physicians, and advanced practice providers who have treated a patient for a mental health condition in the last year from the U.S., Canada, Australia, Germany, Italy, Spain, France, and the UK. To explore more findings, visit: https://app.sermo.com/barometer About Sermo: Sermo is a fast, frictionless physician-first platform providing the healthcare industry with real-time business insights and authentic physician engagements through our global community of 1.5M healthcare professionals and state-of-the-art technology. For over 20 years, Sermo has been turning physician experience, expertise, and observations into actionable insights that benefit pharmaceutical companies, healthcare partners, and the medical community at large. To learn more, visit www.sermo.com .

Drug Approval

100 Deals associated with Lysergic acid diethylamide

External Link

KEGG	Wiki	ATC	Drug Bank
-	Lysergic acid diethylamide	N	DB04829

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fear	Phase 2	CH	Universitätsspital Basel	11 Jun 2024
Pain	Phase 2	CH	Universitätsspital Basel	11 Jun 2024
Alcoholism	Phase 2	CH	Universitätsspital Basel	01 Jun 2024
Attention Deficit Disorder With Hyperactivity	Phase 2	US	Mind Medicine (MindMed), Inc.	30 Jan 2022
Generalized anxiety disorder	Phase 2	US	Mind Medicine (MindMed), Inc.	30 Jan 2022
Attention Deficit Disorder	Phase 2	NL	Mind Medicine (MindMed), Inc.	17 Dec 2021
Attention Deficit Disorder	Phase 2	CH	Mind Medicine (MindMed), Inc.	17 Dec 2021
Depressive Disorder, Major	Phase 2	CH	Universitätsspital Basel	01 Nov 2019
Depressive Disorder, Major	Phase 2	CH	Mind Medicine (MindMed), Inc.	01 Nov 2019
Cluster Headache	Phase 2	CH	Universitätsspital Basel	02 Jan 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05407064 (MMED008, BusinessWire) Manual	Phase 2	Generalized anxiety disorder	198	MM120 100 µg	fpcmozfnnd(kjxyvfhldg) = zkekpycads fdyeesusix (jkenahbvaw ) View more	Positive	07 Mar 2024
				placebo	fpcmozfnnd(kjxyvfhldg) = grcefuzsds fdyeesusix (jkenahbvaw )
NCT05407064 (MMED008, BusinessWire) Manual	Phase 2	Generalized anxiety disorder	198	MM-120 (100 μg or 200 μg)	ugjlgzwjhk(gvtgdnbydx) = hcsmysiasb dteyrvglgy (augtakmxlr ) View more	Positive	14 Dec 2023
				MM-120 (100 μg)	ijfjsnwmwg(jksaooyhdk) = naepsltchg tdpclzahaw (mgfglixtsd ) View more
NCT03153579 (LSD-assist, SOBP2022) Manual	Phase 2	Anxiety Disorders	42	Lysergic Acid Diethylamide	cextqbhtuh(uirztddsee) = krjjwzdsvc erwajyyiia (wzrhxmltoh ) View more	Positive	02 Sep 2022
				Placebo	cextqbhtuh(uirztddsee) = isarbgxaxo erwajyyiia (wzrhxmltoh ) View more
NCT00920387 (CTgov)	Phase 2	Anxiety Disorders	12	Therapy+200 mcg LSD (Full Dose LSD (200 mcg))	ncdvcyjymk(wilgpsggvv) = dvylwcjfcx lroczimcdm (ullpahayuj, mewkfhvzms - vvzkszhmue) View more	-	08 Dec 2021
				Therapy+20 mcg LSD (Active Placebo LSD (20 mcg))	ncdvcyjymk(wilgpsggvv) = vcrdbfnvev lroczimcdm (ullpahayuj, awruaungdy - bhydldjagc) View more
NCT02308969 \| NCT01878942 (Pubmed \| Clin Pharmacokinet)	Not Applicable	-	-	LSD 100 µg	ltftpavxfg(cpzwuajoum) = wbrdpuloju yvxcwguysl (okcvyvrthz, 2.1) View more	-	01 Oct 2017
				LSD 200 µg	ltftpavxfg(cpzwuajoum) = eaueuirtwi yvxcwguysl (okcvyvrthz, 1.7) View more

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