New England Journal of Medicine
October 4, 2023
Andreas Reif, Istvan Bitter, Jozefien Buyze et al.
197 citations
In treatment-resistant depression, esketamine nasal spray combined with an SSRI or SNRI led to remission in 27.1% of patients at week 8, compared to 17.6% for extended-release quetiapine plus an SSRI or SNRI. Over 32 weeks, 21.7% of patients on esketamine had no relapse after remission versus 14.1% on quetiapine. The open-label, single-blind, randomized trial included 676 patients. Adverse events matched known safety profiles. Esketamine was superior to quetiapine for achieving remission and preventing relapse.
European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology
August 1, 2024
Roger S McIntyre, Istvan Bitter, Jozefien Buyze et al.
30 citations
In the ESCAPE-TRD trial, esketamine nasal spray caused treatment-emergent adverse events more often than quetiapine extended release (91.9% versus 78.0%), but these events were typically mild or moderate and transient: 92.0% resolved the same day, and only 4.2% of patients discontinued esketamine due to adverse events compared with 11.0% for quetiapine. The median proportion of days with adverse events was lower with esketamine (11.9% versus 21.3%). Along with greater efficacy, esketamine's tolerability profile supports its use for treatment-resistant depression.
The lancet. Psychiatry
January 1, 2025
Carolina Seybert, Nina Schimmers, Lucio Silva et al.
26 citations
Reporting on the psychological intervention component of psychedelic-assisted psychotherapy is mostly incomplete and inconsistent across studies, limiting replicability and clinical translation. A systematic review of 45 original studies on psilocybin, MDMA, LSD, or ayahuasca for mental disorders found that descriptions of psychotherapy varied widely and completeness of information was generally low, based on an adapted Template for Intervention Description and Replication checklist. Studies involving MDMA showed more homogeneous psychotherapy and more procedural details. Improved reporting on psychological interventions would support replicability, generalisability, and accurate interpretation of research, as well as enhance feasibility and safety of future clinical research and real-world implementation.
Nature Medicine
June 14, 2023
Carolina Seybert, Gonçalo Cotovio, Luís Madeira et al.
24 citations
No Summary
The American journal of psychiatry
January 1, 2025
Roger S McIntyre, Angela T H Kwan, Rodrigo B. Mansur et al.
23 citations
Psychedelics show promise for treating difficult-to-treat psychiatric disorders like major depressive disorder, treatment-resistant depression, and posttraumatic stress disorder, with preliminary evidence also supporting efficacy in tobacco and alcohol use disorders. However, concerns exist about the interpretability and translatability of study results due to insufficiently characterized short- and long-term safety, abuse liability, and the essentiality of the psychedelic experience and psychological support. This overview reviews methodological aspects affecting inferences and interpretation of extant psychedelic studies and provides guidance for future research and development critical to study interpretation and clinical implementation.
Frontiers in Psychiatry
October 31, 2023
Albino J Oliveira-Maia, Benoit Rive, Joachim Morrens et al.
6 citations
An adjusted indirect comparison of treatment strategies for treatment-resistant depression found that esketamine nasal spray plus an antidepressant led to a higher probability of response (49.7%) and remission (33.6%) at six months compared with real-world polypharmacy strategies (26.8% response, 19.4% remission). Esketamine was about 1.86 times as likely to produce a response and 1.74 times as likely to produce remission. Threshold and sensitivity analyses indicated these results were robust to potential unmeasured confounders.
Journal of Psychopharmacology
September 12, 2025
Stephan Tap, Kelan Thomas, Tomáš Páleníček et al.
5 citations
Classic psychedelics like psilocybin are being studied for psychiatric disorders. Current protocols typically require patients to stop antidepressants (ADs) for at least two weeks before psychedelic use to avoid serotonin syndrome and preserve efficacy, but discontinuation can worsen depression and increase suicidal ideation. This scoping review of 18 studies found that using ADs alongside classic psychedelics is generally safe and tolerable, with no increased risk of serotonin syndrome, especially with psilocybin. Some studies showed significant improvements in depression and other symptoms. Although some evidence suggests a potential reduction in acute subjective psychedelic effects, this was not consistent. The authors conclude that maintaining ADs may improve patient access and avoid discontinuation risks.
Frontiers in Psychiatry
January 1, 2024
Albino J Oliveira-Maia, Benoit Rive, Yordan Godinov et al.
3 citations
About 10-30% of people with major depressive disorder have treatment-resistant depression (TRD), and most do not respond to real-world treatments. An indirect comparison of two studies found that after six months, patients with TRD who received esketamine nasal spray plus an antidepressant had a 25.6% probability of achieving functional remission, measured by a Sheehan Disability Scale score of 6 or less, compared to an adjusted 11.5% probability for those receiving real-world treatments. This represents a relative risk of 2.226. Across both groups, patients who did not achieve clinical response or remission had low probabilities of functional remission (5.84% and 8.76%, respectively), while those who did had higher probabilities (43.
Brain Stimulation
October 5, 2021
Gonçalo Cotovio, Albino J Oliveira-Maia, Carter Paul et al.
3 citations
Transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex does not reduce depressive symptoms more than sham stimulation in patients with treatment-resistant depression. In a randomized controlled trial, both active and sham tDCS groups showed similar improvements in depression scores over six weeks, with no significant difference between them. The findings suggest that tDCS, as administered in this protocol, is not effective as a standalone treatment for this population.
Eur Neuropsychopharmacol
June 5, 2026
Andreas Reif, A. Elif Anıl Yağcıoğlu, Istvan Bitter et al.
No Summary
Revista Portuguesa de Psiquiatria e Saúde Mental
September 8, 2021
Gonçalo Cotovio, Ana Maia, Ana Velosa et al.
No Summary