Importance: Psychedelic drugs possess acute psychoactive effects that can compromise blinding integrity in randomized clinical trials (RCTs). Functional unblinding, when participants or raters correctly identify treatment allocation based on subjective effects, may bias outcomes through expectancy effects, challenging the validity of efficacy estimates and regulatory acceptance. Objective: To...
Background: Results from contemporary clinical trials of serotonergic psychedelic therapies have led to an increasing focus on their potential clinical use across mental disorders. However, studies examining mechanisms of clinical response to psychedelic therapy in psychiatric populations are limited. This review aimed to synthesize evidence from studies examining biomarkers of clinical...
Background: Suicidal ideation, attempts, and deaths present a major and tragic public health concern. Recent trials of psilocybin therapy (PT) have shown promise in treating treatment-resistant depression and have found a reduction in suicidal ideation. Given the growth of PT research, there is a need to further understand its effect on suicidal ideation, attempts, and deaths. Objective: To...
Accumulating evidence suggests that psilocybin can produce rapid and sustained clinical benefits when administered in conjunction with psychological support. Though non-pharmacological procedures are considered integral, the field lacks therapeutic guidelines and little is known about current practices. This systematic review sought to provide a comprehensive and cross-diagnostic synthesis of...
Objective: Psychiatric inpatients represent an acutely vulnerable population with high rates of suicidality (ie, suicidal ideation, attempts, and completed suicide). This systematic review aimed to evaluate treatments for suicidality delivered within inpatient settings. Data Sources: MEDLINE, Embase, APA PsycInfo, CINAHL, and The Cochrane Library were systematically searched using 3 concepts:...
Mindfulness-Based (non-contact) Boxing Therapy (MBBT) is a novel intervention designed to empower and promote self-agency through behavioral interventions, while reducing barriers to exercise for individuals with mental disorders. MBBT is an instructor-led, manualized, non-contact boxing group-exercise program (delivered in 90 min sessions, twice a week, over 10 weeks) that blends principles of...
Introduction: Effective blinding is especially challenging in randomized controlled trials (RCTs) involving psychedelics due to the inherent alterations in consciousness that these compounds induce. In this systematic review and exploratory analysis, we aim at synthesizing the methodologies used in RCTs involving classic psychedelics and identify procedures that can help minimize unblinding and...
There has been a resurgence of interest in the use of psychedelic therapies for several mental and substance use disorders. Psilocybin, a "classic" serotonergic psychedelic, has emerged as one of the primary compounds of interest in clinical research. While research on psilocybin's potential mental health benefits has grown, data on the safety and efficacy of other serotonergic psychedelics...
Background Randomised controlled trials (RCTs) of psilocybin have reported large antidepressant effects in adults with major depressive disorder and treatment-resistant depression (TRD). Given psilocybin's psychedelic effects, all published studies have included psychological support. These effects depend on serotonin 2A (5-HT2A) receptor activation, which can be blocked by 5-HT2A receptor...
Antidepressants are associated with symptomatic worsening in a subgroup of patients. Replicated evidence has demonstrated rapid and robust antidepressant effects with intravenous (IV) ketamine in treatment resistant depression (TRD); however, the risk of ketamine worsening depressive symptoms in a subgroup of patients remains unknown. Herein we report a retrospective analysis on the rates of...
Most interventions for treatment-resistant depression (TRD) are added as augmenters. We aimed to determine the relative effectiveness of augmentation treatments for TRD. This systematic review and network meta-analysis (NMA) sought all randomized trials of pharmacological and psychological augmentation interventions for adults meeting the most common clinical criteria for TRD. The NMA compared...