Back to table of contents Previous article Next article Clinical & ResearchFull AccessAustralia Legalizes Psychedelics for Use in Depression, PTSD TherapyNick ZagorskiNick ZagorskiSearch for more papers by this authorPublished Online:15 Aug 2023https://doi.org/10.1176/appi.pn.2023.09.9.20AbstractThe country is the first to make psilocybin and MDMA available ...
Back to table of contents Previous article Next article Med CheckFull AccessMed Check: FDA, Anti-Amyloid Beta Vaccine, Clinical Trials of Psychedelics, and LumryzTerri D’ArrigoTerri D’ArrigoSearch for more papers by this authorPublished Online:27 Jul 2023https://doi.org/10.1176/appi.pn.2023.08.8.3FDA Expedites Review of Anti-Amyloid Beta Vaccine for Alzheime...
Observing that designing clinical studies to evaluate the safety and effectiveness of psychedelic substances presents a number of unique challenges that require careful consideration to the industry, the U.S. Food and Drug Administration (FDA) last month issued, for the first time, draft guidance for conducting clinical trials with psychedelic drugs such as ...
Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety, depression, and increased risk for self-medicating substance abuse. Currently, there are only two approved medications in the United...
Back to table of contents Previous article Next article Annual MeetingFull AccessExperts Offer Tips on Talking With Patients About PsychedelicsTerri D’ArrigoTerri D’ArrigoSearch for more papers by this authorPublished Online:28 Jun 2023https://doi.org/10.1176/appi.pn.2023.07.7.51AbstractPsychedelics differ from one another in their mechanism of action and po...
Abstract Psychoactive substances such as psilocybin and 3,4-methylenedioxy-methamphetamine (MDMA) are currently being investigated for a variety of psychiatric indications including major depressive disorder and post-traumatic stress disorder. It is critical that clinicians working in the mental health field understand the regulatory framework that balances ...
This Special Issue of Neuropharmacology on psychedelics provides a timely and comprehensive update on progress following the previous Neuropharmacology Special Issue "Psychedelics: New Doors, Altered Perceptions". Remarkable advances have been made in basic and clinical research on psychedelics in the five years since 2018. It is partly based on the seminar ...
With the Food and Drug Administration designation in 2017 of 3,4-methylenedioxymethamphetamine (MDMA) as a breakthrough therapy in post-traumatic stress disorder and psilocybin in treatment-resistant depression, psychedelic drugs have continued to garner the attention of researchers and clinicians for their promise of unmatched, rapid improvement in a multit...
Major depressive disorder presents a substantial global health burden, and at least 30-40% of patients exhibit treatment resistance to antidepressants. Ketamine, an NMDA receptor antagonist, is used as an anesthetic agent. In 2019, the U.S. Food and Drug Administration (FDA) approved esketamine (the S-enantiomer of ketamine) as a therapeutic agent for treatm...
The clinical evaluation of hallucinogens and other small molecules, conventionally termed psychedelics, has seen a dramatic increase in the past 5 years. Several key clinical trials recently demonstrated the potential efficacy of these compounds in treating a variety of mental health conditions including depression, anxiety, and substance use disorders. Conc...
One in three adults with major depressive disorder (MDD) do not experience clinically significant improvement after multiple sequential courses of antidepressants and have treatment-resistant depression (TRD). The presence of TRD contributes to the morbidity and excess mortality associated with MDD and has been linked to significantly increased health care e...
Back to table of contents Previous article Next article Government & LegalFull AccessPsychedelics Legislation Gains MomentumTerri D'ArrigoTerri D'ArrigoSearch for more papers by this authorPublished Online:16 Feb 2023https://doi.org/10.1176/appi.pn.2023.03.3.4AbstractBills that would decriminalize the use of psychedelics are popping up faster than magic mush...
Participants with depression will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo positron emission tomography (PET) imaging before and one week after psilocybin using a marker of synaptic density. This design allows us to assess the relationship between neurotrophic, ...
Objective: Psychedelic drug therapy is banned in all countries of the world except Australia, where the government regulatory watchdog, the Therapeutic Goods Administration, is planning to allow approved psychiatrists, as of July 1, 2023, to prescribe psilocybin to treat depression and MDMA to treat post-traumatic stress disorder, a move precipitated by the ...
BACKGROUND: Psychedelics are an increasingly active area of research and pharmaceutical development. This includes abuse potential assessment to better understand their pharmacological mechanisms and effects and guide controlled substance regulation. Psychedelics pose challenges to abuse assessments to ensure valid, reliable, and generalizable outcomes and s...
Acknowledging the barrage of research, media attention and capital investment focused on psychedelic compounds and the race to reach U.S. Food and Drug Administration (FDA) approval for such currently illegal drugs as psilocybin, nearly two dozen experts have weighed in on a new report that, among other things, calls attention to the critical role they said ...
Post-traumatic stress disorder (PTSD) is a devastating psychiatric disorder afflicting millions of people around the world. Characterized by severe anxiety, intrusive thoughts, pervasive nightmares, an assortment of somatic symptoms, associations with severe long-term health problems, and an elevated risk of suicide, as much as 40-70% of patients suffer from...
There is mounting evidence suggesting psychedelic and entactogen medicines (namely psilocybin and 3,4-methylenedioxymethamphetamine [MDMA]), in conjunction with proper psychosocial support, hold the potential to provide safe, rapid acting, and robust clinical improvements with durable effects. In the US, both psilocybin and MDMA have been granted Breakthroug...
Back to table of contents Previous article Next article Med CheckFull AccessMed Check: Psilocybin for OCD, Nuplazid Vote, and MoreTerri D’ArrigoTerri D’ArrigoSearch for more papers by this authorPublished Online:4 Aug 2022https://doi.org/10.1176/appi.pn.2022.08.8.2AD109 Fast Tracked for Obstructive Sleep ApneaThe U.S. Food and Drug Administration (FDA) has g...
The Food and Drug Administration (FDA) granted breakthrough therapy status to 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) in 2017 due to preliminary evidence supporting its efficacy and safety in treating post-traumatic stress disorder (PTSD). A series of six phase-II clinical trials studying MDMA-AT for treatment-resistant PTSD found that...
