The therapeutic benefits of psychedelics for neuropsychiatric conditions have gathered significant attention in Europe and around the world, with treatments using psilocybin, MDMA, and ketamine as notable examples. However, the mind-altering effects of these substances, and the complexity of their regulatory frameworks, both within and outside of therapeutic use, imply careful clinical...
The research, understanding, and implementation of psychedelic therapies is characterised by a layered complexity that arises from the dynamic interactions between pharmacological and extra-pharmacological factors, and the embeddedness of psychedelics within broader societal, legal, and regulatory systems ill-equipped to accommodate them. This complexity is compounded by an epistemic...
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Optimising patient outcomes in treatment resistant depression (TRD) requires treatments which provide sustained remission, without relapse, and tolerability in the long term. ESCAPE-LTE (NCT04829318) was a phase IV, single-arm, 2-year (104 weeks) long-term extension of ESCAPE-TRD (NCT04338321; 32 weeks), a rater-blinded, randomised, active-controlled trial, which evaluated the safety,...
Ketamine-assisted psychotherapy (KAP) is considered a promising treatment strategy in psychiatric disorders, combining psychotherapeutic interventions with the rapid-acting pharmacological effects of ketamine towards enhancing outcomes. Although KAP has been practiced for many years across different diagnoses, evidence regarding optimal treatment methods and working mechanisms remains limited...
Classic psychedelics are increasingly studied as potential treatments for different psychiatric disorders. Current research protocols often require patients to discontinue antidepressants (ADs) for at least 2 weeks before psychedelic administration to decrease the risk of serotonin syndrome and limit their effect on efficacy and the acute subjective effects of psychedelics. Moreover, the...
Abstract The potential of psychedelic substances to treat mental illness is of significant clinical and societal interest, leading to academic and industry-based research to test their effects. Partly, such research was conducted to fulfil requirements of government agencies such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), that have started defining...
Although studies of psychedelic-assisted psychotherapy are accumulating, there is no consensus regarding best practice of the psychotherapeutic component. In this systematic review, we summarised the quality of reporting on psychological interventions in research about psychedelic treatments. The design followed PRISMA guidelines and was preregistered in PROSPERO (CRD42022319221). We searched...
During the past decade, there has been extraordinary public, media, and medical research interest in psychedelics as promising therapeutics for difficult-to-treat psychiatric disorders. Short-term controlled trial data suggest that certain psychedelics are effective and safe in the treatment of major depressive disorder, treatment-resistant depression, and posttraumatic stress disorder....
In ESCAPE-TRD (NCT04338321), esketamine nasal spray (NS) significantly increased the probability of remission at Week 8, and of being relapse-free through Week 32 after remission at Week 8, versus quetiapine extended release (XR) in patients with treatment resistant depression (TRD). Here, we explore the time course, burden and consequences of treatment emergent adverse events (TEAEs) in the...
Treatment resistant depression (TRD) affects approximately 10-30% of patients with major depressive disorder, and most patients with TRD do not respond to real-world treatments (RWT). Treatment with esketamine nasal spray (NS) plus a selective serotonin or serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) has significant long-term clinical benefit over RWT in patients with TRD. However,...
BackgroundThe efficacy of esketamine nasal spray (NS) as a rapid-acting agent for treatment resistant depression (TRD) was demonstrated in comparisons with placebo, when both were given in addition to a newly initiated selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI). How esketamine NS compares with commonly used real-world (RW) polypharmacy...
BACKGROUND: In treatment-resistant depression, commonly defined as a lack of response to two or more consecutive treatments during the current depressive episode, the percentage of patients with remission is low and the percentage with relapse is high. The efficacy and safety of esketamine nasal spray as compared with extended-release quetiapine augmentation therapy, both in combination with...
Funding Information: GC was funded by Funda??o para a Ci?ncia e Tecnologia (FCT; Portugal) through a PhD Scholarship (SFRH/BD/130210/2017). AJO-M was funded by FCT (Portugal) through a Junior Research and Career Development Award from the Harvard Medical School ? Portugal Program (HMSP-ICJ/0020/2011). GC and AJO-M were supported by grant PTDC/MED-NEU/31331/2017, and AJO-M by grant...