Psychiatric News
August 15, 2023
Nick Zagorski
3 citations
Australia became the first country to legalize MDMA and psilocybin for medical use by prescription, effective July 2023, as part of psychedelic-assisted psychotherapy for PTSD and treatment-resistant depression. Psychiatrists note that while phase 3 trials for MDMA are completed, psilocybin's phase 3 trials have just begun, with combined data from earlier studies involving just over 100 subjects and a larger phase 2 study of 233 participants showing positive results at 12 weeks. However, barriers include high costs (around $25,000 Australian dollars for a full course), lack of trained therapists, domestic manufacturers, and unclear standards of care. Experts caution that rigorous safety measures are needed and that Australia's decision may not influence U.S. regulatory timelines.
Psychiatric News
July 27, 2023
Terri D’arrigo
1 citation
The FDA granted fast track status to ACI-24.060, an investigational anti-amyloid beta vaccine for Alzheimer's disease, supported by early data from the phase 1b/2 ABATE trial. In that double-blind, placebo-controlled study of patients with prodromal Alzheimer's disease, the low-dose cohort showed an anti-amyloid beta antibody response as early as week 6, two weeks after the second injection. The treatment was safe and well-tolerated with no serious safety concerns. The FDA also issued draft guidance on clinical trials of psychedelics, covering classic psychedelics and entactogens, and Lumryz became available in the U.S. for adults with narcolepsy after a phase 3 trial showed improvements in sleepiness and cataplexy compared with placebo.
Psychiatric News
June 28, 2023
Nick Zagorski
1 citation
Clinicians offering psychedelic-assisted psychotherapy should provide enhanced informed consent that goes beyond standard practice, according to presenters at an APA Annual Meeting session. Because psychedelic effects are often ineffable and can include spiritual experiences, discomfort, or challenging reactions, patients need detailed information about possible outcomes. A survey of recreational psychedelic users found that about 40% rated a bad trip as one of the most challenging experiences of their lives. Clinicians should also discuss risks such as emergent psychosis, re-exposure to old traumas, and the potential for therapeutic touching, establishing clear boundaries beforehand to prevent violations.
Psychiatric News
March 31, 2021
Stanley N. Caroff
1 citation
A psychiatrist warns that the current revival of psychedelic drugs for therapeutic use risks repeating the opioid crisis if commercial interests are not restrained. While early trials show promise for conditions like PTSD and depression, most evidence comes from uncontrolled or underpowered studies, and serious adverse effects—including psychosis, hyperthermia, and life-threatening complications—are documented in unsupervised settings. The author argues that approval by agencies like the FDA, combined with aggressive marketing, could lead to widespread misuse, especially among vulnerable groups. He calls for rigorous safeguards, public education, and prioritizing broader access to primary care and social services over commercial psychedelic expansion.
Psychiatric News
September 29, 2020
Nicole Harrington Cirino
1 citation
The author argues that Oregon's ballot Measure 109, which would legalize psilocybin treatment without FDA approval, is premature and dangerous. Safety and efficacy for psilocybin have not been established according to FDA guidelines; phase 3 trials have not started. The measure would allow nonmedical providers to administer a Schedule 1 controlled substance for an overly broad range of psychiatric conditions, without oversight by psychiatrists. The Oregon Psychiatric Physicians Association and APA oppose the measure, urging the public to wait for scientific evidence before widespread use.
Psychiatric News
October 28, 2019
Nick Zagorski
1 citation
Johns Hopkins University has launched a Center for Psychedelic and Consciousness Research, funded by $17 million in private donations that will provide five years of operational support. The center will focus on studying psychedelic compounds, initially psilocybin, for treating psychiatric disorders. Planned clinical studies will examine psilocybin for opioid use disorder, posttraumatic stress disorder, alcohol use disorder with depression, Alzheimer's disease, Lyme disease, and anorexia nervosa. Researchers emphasize that these are early-stage studies and that psychedelic research must proceed cautiously, as the substances have risks and require supervised use.
Psychiatric News
May 10, 2024
Terri D’arrigo
Calls to U.S. poison centers about youth and young adults who took the psychedelic psilocybin have risen sharply since 2019, coinciding with the start of a psilocybin decriminalization movement across numerous states and cities. Over a 10-year period (2013–2022), there were 4,055 calls for psilocybin exposure among people aged 13 to 25, with about 66% involving psilocybin alone. Common clinical effects included hallucinations or delusions, agitation, elevated heart rate, or confusion. Most exposures required professional medical attention, but only two deaths were reported, both involving a secondary substance (fentanyl and amphetamine).
Psychiatric News
April 23, 2024
Terri D’arrigo
In a phase 2 trial, the psilocybin analog CYB003 given adjunctively to 34 patients with moderate to severe major depressive disorder produced an average 22-point reduction on the Montgomery–Åsberg Depression Rating Scale after four months; 60% of those receiving 12 mg and 75% of those receiving 16 mg achieved remission. No drug-related serious adverse events or suicidal ideation occurred. Separately, the LSD formulation MM120 for generalized anxiety disorder showed that 100 µg led to an average 21.3-point reduction on the Hamilton Anxiety Rating Scale at week 4 versus 13.7 points for placebo, with similar results at week 12.
Psychiatric News
April 19, 2024
Adrian Preda
Psychedelic clinical trials face unique methodological challenges in randomization, blinding, and control that require more stringent standards than typical psychotropic trials. Randomization is compromised when participants self-select based on interest in psychedelic experiences rather than clinical need; solutions include recruiting from clinical populations with documented diagnoses and excluding those with prior psychedelic use. Blinding is difficult because psychedelics produce noticeable physiological and psychological changes; active controls with similar effects but without therapeutic benefits, such as microdosing or subtherapeutic doses of other psychotropics, are recommended. Control is complicated by combining psychedelics with psychotherapy in nonclinical settings; a factorial design with additional arms for active control plus psychotherapy and active intervention plus placebo psychotherapy is proposed.
Psychiatric News
April 1, 2024
Adrian Preda
The author argues that societal attitudes toward psychedelics, like many other beliefs, follow a pendulum-like swing between acceptance and rejection driven more by cultural forces than by evidence. Historically, psychedelics were used under strict rules, became popular in the 1960s counterculture, then were demonized due to high-profile incidents. Today, a resurgence of interest is supported by both data and a cultural shift toward acceptance. The author, a clinician, expresses concern that current clinical trials on psilocybin and LSD, when stripped of the substance's name, would likely not be published in top medical journals, suggesting the evidence is weak. The article warns that hype and rapid momentum risk destabilizing a fragile body of knowledge.
Psychiatric News
March 26, 2024
Terri D’arrigo
A phase 2 clinical trial of the investigational psilocybin product PSX-001 for generalized anxiety disorder found that patients receiving psilocybin with psychotherapy showed a 12.8-point reduction on the Hamilton Anxiety Rating Scale, compared with a 3.6-point reduction in the placebo group. 44% of psilocybin patients achieved at least a 50% reduction in anxiety scores, more than four times the placebo rate, and 27% achieved full remission, more than five times the placebo rate. The FDA rejected the New Drug Application for roluperidone for negative symptoms of schizophrenia, citing insufficient evidence of effectiveness and safety.
Psychiatric News
June 28, 2023
Terri D’arrigo
Psychedelics differ from one another in their mechanism of action and potential effects, and psychiatrists should be prepared to discuss them with patients. Experts at APA's 2023 Annual Meeting offered an overview of research and talking points. An open-label trial of ibogaine and magnesium in veterans with traumatic brain injury found that one month after treatment, 80% of patients were within the healthy range on scales for PTSD, depression, and anxiety; six months after, more than 80% were within healthy range for PTSD and anxiety, and more than 70% for depression. Patients also showed reduced moral injury and suicidal ideation, and increased cortical thickness in mood-regulation brain areas.
Psychiatric News
March 27, 2023
Terri D’arrigo
A session at APA's Annual Meeting will address ethical and practical issues surrounding psychedelic-assisted psychotherapy, including informed consent, patient vulnerability, equity, and access. The panel, featuring members of APA's Council on Addictions, the American Indian, Alaska Native, and Native Hawaiian Caucus, and APA's Ethics Committee, will discuss challenges in the current investigational stage and considerations if psychedelics become available for broad clinical use. Topics include research equipoise, informed consent, patient vulnerability, equity and access, and psychedelic self-enhancement. The future success of psychedelic therapies depends on ensuring ethical use and responsible practice by mental health professionals.
Psychiatric News
February 16, 2023
Terri D'Arrigo
Between January 2019 and September 2022, 25 U.S. states considered 74 bills to reform laws restricting psychedelic drugs; 10 bills became law in seven states. Most bills (90%) referenced psilocybin, and 36% also included MDMA. Among decriminalization bills, 51% called for legalizing possession for therapeutic or recreational use, while only 35% required training or licensure for prescribing. The authors note that the proposed laws largely contradict the federal Controlled Substances Act. Psychiatrists quoted in the article emphasize that psychedelics remain almost exclusively investigational and that rigorous scientific study and FDA approval should guide therapeutic use, not ballot initiatives.
Psychiatric News
December 26, 2022
Nick Zagorski
A single 25-mg dose of psilocybin, given with psychological support, reduced depression symptoms for at least three weeks in adults with treatment-resistant depression. In a trial at 22 sites across 10 countries, 233 participants were randomized to 1 mg, 10 mg, or 25 mg of psilocybin. After three weeks, depression scores on the Montgomery–Åsberg Depression Rating Scale dropped by 12.0 points in the 25-mg group, 7.9 points in the 10-mg group, and 5.4 points in the 1-mg group; the difference between the 25-mg and 10-mg groups was statistically significant, but the difference between the 10-mg and 1-mg groups was not.
Psychiatric News
August 1, 2022
Terri D’arrigo
The FDA has granted fast track status to AD109, an investigational oral medication for obstructive sleep apnea that combines atomoxetine and aroxybutynin. In a phase 2 trial of 32 adults with mild to moderate obstructive sleep apnea, patients who took AD109 experienced less hypoxic burden and fewer episodes of apnea and hypopnea per hour of sleep compared with those who took placebo. Separately, the FDA accepted an Investigational New Drug application for a phase 2 trial of synthetic psilocybin (SYNP-101) for obsessive-compulsive disorder, in which 105 patients will receive 25 mg of SYNP-101 or niacin. An FDA advisory committee voted 9 to 3 that evidence does not support Nuplazid for Alzheimer's disease psychosis.
Psychiatric News
June 28, 2022
Nick Zagorski
At two APA Annual Meeting sessions, researchers discussed how psychedelics work in the brain and whether the out-of-body or mystical experiences they produce are necessary for therapeutic benefit. Robin Carhart-Harris proposed that psychedelics lower the brain's confidence in its prior beliefs, forcing it to build a model of the world from the bottom up rather than top-down, a state he calls REBUS (Relaxed Beliefs Under Psychedelics). This period of neural plasticity may enable positive change in therapy.
Psychiatric News
May 23, 2022
Richard Karel
In a small study of 24 adults with major depressive disorder, psilocybin-assisted therapy produced rapid and substantial antidepressant effects lasting up to one year, with no serious adverse effects. At 12 months, 75% of participants showed a treatment response (at least 50% reduction in depression scores) and 58% achieved remission. Participants' ratings of personal meaning, spiritual experience, and mystical experience after sessions predicted increased well-being at 12 months but did not predict improvement in depression, suggesting that well-being changes may not be captured by standard depression scales. The authors note that long-term efficacy and safety are not yet known and larger studies are needed.
Psychiatric News
January 28, 2022
Claire Zilber
The APA and district branch ethics committees have shifted from adjudicating complaints to proactively educating members about ethical dilemmas in psychiatry, such as physician aid in dying and psychedelic-assisted psychotherapy. The APA Ethics Committee now issues opinions and resource materials, hosts forums at annual meetings, and updates guidance on ethical decision-making. District branches like the Colorado Psychiatric Society have provided guidance on emerging issues, including physician aid in dying and psychedelic treatments. The goal is to help psychiatrists recognize and deliberate about dilemmas before acting, support ethical decision-making, and prevent ethics infractions.
Psychiatric News
January 1, 2022
T. D'Arrigo
Two phase 3 trials of Aduhelm (aducanumab) found that reductions in plasma p-tau correlated with less cognitive and functional decline in Alzheimer's disease patients. In the EMERGE trial, p-tau decreased 13% from baseline in the high-dose group and rose 8% in the placebo group; in the ENGAGE trial, p-tau decreased 16% from baseline in the high-dose group and rose 9% in the placebo group. A phase 2 trial of COMP360 psilocybin for treatment-resistant depression found that at week 3, 36.7% of patients receiving 25 mg improved on the MADRS scale versus 17.7% receiving 1 mg. A study in the New England Journal of Medicine found that oxytocin nasal spray did not improve social functioning in 277 children with autism spectrum disorder compared with placebo.
Psychiatric News
July 22, 2021
Nick Zagorski
A phase 3 trial of MDMA-assisted psychotherapy for chronic PTSD in 90 adults found that scores on the Clinician-Administered PTSD Scale for DSM-5 dropped by almost 25 points among those who received MDMA before therapy, compared with 14 points among those who received placebo. MDMA was well-tolerated, with no increase in suicidal ideation or abuse potential. A second phase 3 trial is underway. Experts caution that long-term effects remain unclear; psilocybin-assisted psychotherapy for cancer-related depression showed over 60% of participants still alive 4.5 years later continued to show an antidepressant response, but a separate study found psilocybin no more effective than escitalopram for major depression over six weeks.
Psychiatric News
April 1, 2021
Charles S. Grob
After decades of limited research, psychedelics have returned to clinical investigation, driven largely by private funding. Early 1950s and 1960s studies suggested potential benefits for serious, treatment-resistant conditions such as substance use disorders, obsessive-compulsive disorder, chronic posttraumatic stress disorder, and end-of-life anxiety. However, a cultural and political backlash led to restrictive laws that halted most research until the 21st century. The author argues that while psychedelic therapies hold promise, they also carry risks of adverse effects, which can be minimized through careful screening and controlled settings. Maintaining strong ethical structures is essential to avoid repeating past mistakes and to ensure patient safety and equitable access.
Psychiatric News
March 1, 2021
Nick Zagorski
No Summary
Psychiatric News
April 13, 2020
Nick Zagorski
A review by APA's Work Group on Biomarkers and Novel Treatments examines the pharmacology and clinical trials of four psychedelic agents—MDMA, psilocybin, LSD, and ayahuasca—for psychiatric disorders. Placebo-controlled trials show efficacy of MDMA for PTSD and psilocybin for depression and cancer-related anxiety; evidence for LSD and ayahuasca remains preliminary. The report calls for standard protocols and rating scales, and notes that Schedule I classification hinders research by requiring DEA approval and limiting federal funding. The work group does not advocate clinical use but suggests the field needs NIH support and an international symposium to set shared priorities.
Psychiatric News
March 20, 2020
Katie O’connor
Psychedelics such as LSD, MDMA, ketamine, and psilocybin show promise for treating substance use disorders, with early results suggesting patients may become substance-free for months or a year after a single treatment. Barriers to research persist, including Schedule I classification and misconceptions among psychiatrists, though 81% of surveyed psychiatrists agreed the drugs deserve further research. In one trial, psilocybin combined with cognitive-behavioral therapy produced a 56% smoking abstinence rate at one year versus 17% for nicotine patch. An observational study of ibogaine for opioid use disorder found half of 30 participants reported no opioid use one month after treatment.