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 The FDA also issued draft guidance on clinical trials of psychedelics, covering classic psychedelics and entactogens, and Lumryz became available in the U.S. for adults with narcolepsy after a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
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
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
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.