A phase I, open-label, single-dose, mass balance study to investigate the absorption, distribution, metabolism, and excretion of COMP360 [14C]-psilocybin in healthy male participants

开始日期2024-11-12

申办/合作机构

Compass Pathfinder Ltd.

CTIS2023-505268-12-00 / Recruiting

A Phase III, multicentre, randomised, double-blind, controlled study to investigate the efficacy, safety, and tolerability of two initial administrations of COMP360 in participants with treatment-resistant depression - COMP 006

开始日期2024-02-09

申办/合作机构

Compass Pathfinder Ltd.

ISRCTN16636661 / Recruiting临床1期

A phase I, open-label, randomised-sequence, two-way crossover study to assess the relative oral bioavailability of 25 mg and 5 mg strength capsules of COMP360 in healthy volunteers

开始日期2022-10-24

申办/合作机构

Compass Pathfinder Ltd.

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2024-06-01·Journal of Child Psychology and Psychiatry

Editorial Perspective: Bridging the translational neuroscience gap in autism – development of the ‘shiftability’ paradigm

作者: McAlonan, Grainne M ; Murphy, Declan G M ; Malievskaia, Ekaterina ; Whelan, Tobias P ; Puts, Nicolaas A ; Daly, Eileen

Clinical trials of pharmacological candidates targeting the core features of autism have largely failed. This is despite evidence linking differences in multiple neurochemical systems to brain function in autism. While this has in part been explained by the heterogeneity of the autistic population, the field has largely relied upon association studies to link brain chemistry to function. The only way to directly establish that a neurotransmitter or neuromodulator is involved in a candidate brain function is to change it and observe a shift in that function. This experimental approach dominates preclinical neuroscience, but not human studies. There is little direct experimental evidence describing how neurochemical systems modulate information processing in the living human brain. Thus, our understanding of how neurochemical differences contribute to neurodiversity is limited, impeding our ability to translate findings from animal studies into humans. Here, we introduce our ‘shiftability’ paradigm, an approach to bridge the translational gap in autism research. We provide an overview of the guiding principles and methodologies we use to directly test the hypothesis that neurochemical systems function differently in autistic and non‐autistic individuals.

2023-09-01·Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology

Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication.

Article

作者: Stansfield, Susan C ; Croal, Megan ; Kelly, John R ; Marwood, Lindsey ; Simmons, Hollie ; Mistry, Sunil ; Feifel, David ; Sisa, Claudia ; Malievskaia, Ekaterina ; Peck, Stephanie Knatz ; O'Keane, Veronica ; Williams, Sam ; Tsai, Joyce ; Goodwin, Guy M

Psilocybin is being investigated as a treatment in adults with treatment-resistant depression (TRD). Withdrawal from serotonergic antidepressant drugs is a common prerequisite for taking part in trials of psilocybin due to the possibility of ongoing antidepressant drugs altering the psychedelic effect. This phase II, exploratory, international, fixed-dose, open-label study explored the safety, tolerability, and efficacy of a synthetic form of psilocybin (investigational drug COMP360) adjunct to a selective serotonin reuptake inhibitor in participants with TRD. Participants received a single 25 mg dose of psilocybin alongside psychological support and were followed-up for 3 weeks. The primary efficacy end point was change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from Baseline at Week 3. Secondary end points were safety, including treatment-emergent adverse events (TEAEs), the proportion of responders and remitters at Week 3, and the change from Baseline to Week 3 in Clinical Global Impression-Severity (CGI-S) score. Nineteen participants were dosed and the mean Baseline MADRS total score was 31.7 (SD = 5.77). Twelve (63.2%) participants had a TEAE, most of which were mild and resolved on the day of onset. There were no serious TEAEs or indication of increased suicidal ideation or behavior. At Week 3, mean change from Baseline in MADRS total score was -14.9 (95% CI, -20.7 to -9.2), and -1.3 (SD = 1.29) in the CGI-S. Both response and remission were evident in 8 (42.1%) participants. Larger, comparator-controlled trials are necessary to understand if this paradigm can optimize treatment-outcome where antidepressant drug withdrawal would be problematic.

2023-05-01·Journal of Affective Disorders

Unblinding and demand characteristics in the treatment of depression

Article

作者: Marwood, Lindsey ; Croal, Megan ; Malievskaia, Ekaterina ; Goodwin, Guy M

Blinding of treatment allocation in clinical trials in psychiatry is regarded as an ideal. The potential impact of unblinding chimes with a general concern for psychological research: so-called demand characteristics can undermine confidence in findings from experimental and clinical studies. Scepticism can result in nihilism. The reliance on subjective report of symptoms in clinical trials of drug efficacy in depression provides an important example. It is regularly implied that if subjective effects, including specific adverse reactions, unblind participants to an active treatment then evidence for its efficacy is suspect. In fact, the strong association between dose and subjective effects does not translate into a strong relationship with efficacy in randomised controlled trials (RCTs) of conventional antidepressant drugs; this observation falsifies the proposition that unblinding is the principal mechanism driving RCT outcomes in studies of depression. Instead, changes in brain function, that occur soon after treatment starts, do predict treatment outcomes and align with our understanding of neurotransmitter effects from neuroscience. Psychedelic experience for the treatment of depression must be unblinding, but the effect results directly from serotonergic receptor activation and changes in brain connectivity. Where such effects are part of a novel mechanism of action, a strong dose response relationship would be expected, irrespective of unblinding. We highlight the importance of exploring blinding as a mechanism, confirming dose-related outcomes, and dissociating unblinding effects from efficacy. Unblinding does not necessarily invalidate the subjective experience of sustained recovery from depression.

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