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    Efficacy, all-cause discontinuation, and safety of serotonergic psychedelics and MDMA to treat mental disorders: a living systematic review with meta-analysis
    (Elsevier B.V., 2025-12) Højlund, Mikkel; Yılmaz Kafalı, Helin; Kırmızı, Begüm; Fusar-Poli, Paolo; Correll, Christoph U.; Cortese, Samuele; Sabé, Michel; Fiedorowicz, Jess; Saraf, Gayatri; Zein, Josephine; Berk, Michael; Husain, Muhammad I.; Rosenblat, Joshua D.; Rubaiyat, Ruby; Corace, Kim; Wong, Stanley; Hatcher, Simon; Kaluzienski, Mark; Yatham, Lakshmi N.; Cipriani, Andrea; Gosling, Corentin J.; Carhart-Harris, Robin; Tanuseputro, Peter; Myran, Daniel T.; Fabiano, Nicholas; Moher, David; Mayo, Leah M.; Nicholls, Stuart G.; White, Tracy; Prisco, Michele De; Radua, Joaquim; Vieta, Eduard; Ladha, Karim S.; Katz, Jay; Veroniki, Areti A.; Solmi, Marco
    Serotonergic psychedelics and 3,4-methylendioxtmethamphetamine (MDMA) are promising treatments for mental disorders with a continuously evolving evidence base. We searched Pubmed/Scopus/clinical trial registries up to 08july2025 for double-blind randomized controlled trials (RCTs) testing MDMA or serotonergic psychedelics in patients with mental disorders. Primary outcomes were change in disease-specific symptoms and all-cause discontinuation. Standardized mean differences (SMD) and relative risk (RR) were estimated using random-effects meta-analysis. Risk of bias (RoB) was assessed with Cochrane’s RoB-tool version 2 and certainty of evidence with GRADE. The review is maintained as living systematic review ( https://ebipsyche-database.org/ ). We included 30 RCTs (1480 participants; female=45.8 %; with psychological support=83.3 %; high RoB=83.3 %). In post-traumatic stress disorder (PTSD), MDMA reduced PTSD symptoms compared to any control ( k = 11; SMD=-0.85 [-1.09; -0.60]; I2=0 %; GRADE=low). In major depressive disorder (MDD), psilocybin/ayahuasca/LSD reduced depressive symptoms ( k = 8; SMD=-0.62 [-0.97; -0.28]; I2=55 %; GRADE=very low). In anxiety disorders, both MDMA and serotonergic psychedelics reduced anxiety symptoms (SMDMDMA=-1.18 [-2.04; -0.32]; I2=0 %; k = 2; GRADE=low and SMDserotonergic=-0.88 [-1.70; -0.06]; I2=54 %; k = 5; GRADE=very low). In alcohol use disorder, neither psilocybin nor LSD reduced abstinence rates ( k = 6; RR=1.42 [0.89; 2.26]; I2=7 %; GRADE=very low). In attention-deficit hyperactivity disorder (ADHD), LSD did not reduce ADHD symptoms ( k = 1; SMD=0.22 [-0.32; 0.76]; GRADE=very low). Moderate certainty in evidence was only found for MDMA on PTSD symptoms when compared to placebo. MDMA/serotonergic psychedelics were not associated with higher risk of all-cause discontinuation (RRMDMA=0.74 [0.32; 1.72]; RRserotonergic=0.81 [0.56; 1.15]). Overall, MDMA/serotonergic psychedelics are promising for the treatment of PTSD, MDD, and anxiety disorders with moderate to large effect sizes. Pragmatic trials, long-term, head-to-head trials exploring the role of psychological support, aiming to identify predictors of response, and accounting for expectancy and functional unblinding are needed. Studies addressing these limitations will likely be required for regulatory approval of psychedelic drugs.
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    Therapist's assessment of their patient's session-level emotional processes: validation of the in-session patient affective reactions questionnaire–clinician form
    (John Wiley and Sons Inc, 2025-08-06) Stefana, Alberto; Ünver, Buket; Vieta, Eduard; Fusar-Poli, Paolo; Youngstrom, Eric Arden
    Background: The current study aimed to evaluate a therapist version of the in‐Session Patient Affective Reactions Questionnaire(SPARQ). The SPARQ was developed to assess a pattern of emotions, thoughts, and behaviors experienced by a patient towardtheir therapist during a session. The SPARQ has existed only as a patient self‐report measure and has demonstrated promise as apsychotherapy process measure. This study intended to validate a complementary clinician‐report version of the questionnaire:the SPARQ‐C.Methods: A sample of licensed mental health clinicians (N = 151) completed the SPARQ‐C along with other measures. Dataanalysis involved exploratory and confirmatory factor analyses (CFA). Reliability and convergent and criterion‐related validityof the SPARQ‐C were also evaluated.Results: The SPARQ‐C preserved the two‐factor structure: positive affect (k = 4, ω total = 0.84) and negative affect (k = 4, ωtotal = 0.70), which correlated r = 0.26. CFA using the a priori model two‐factor model based on the patient‐report versionprovided the following fit indices: χ2[19] = 26.01, CFI = 0.98; TLI = 0.97, RMSEA = 0.05 (90% CI [0.00, 0.09]), and SRMR = 0.05.The SPARQ‐C scales demonstrated convergent and criterion‐related validity with measures of other elements of the therapeuticrelationship, session outcome, and demographic‐clinical variables.Discussion: The SPARQ‐C is a reliable measure suitable for both clinical and research purposes. It allows for a nuancedassessment of patients' session‐level affective responses towards their therapist from the clinician's perspective.