2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T97e,Psychedelic-assisted therapy (PAT) trials have high levels of functional unblinding, which biases results when comparing PAT with blinded interventions. Because PAT is effectively always open label, treatment results should be compared with those of open-label traditional antidepressants (TADs), so potential benefits associated with patients knowing their treatment is equal between the interventions. To investigate the comparative effectiveness of PAT vs open-label traditional antidepressants (TADs; such as selective serotonin and norepinephrine reuptake inhibitors) for the treatment of major depression. PubMed was systematically searched in March 2024 for trials of PAT and open-label TADs for the treatment of major depression without comorbidity in adults without psychosis in the outpatient setting. Extraction was supplemented with data from a review and meta-analysis of antidepressant drugs to assess the open-label vs blinded TAD difference. Depression scores were extracted by 2 independent reviewers; estimates were pooled with both bayesian and frequentist mixed-effects models. Reporting follows the PRISMA guideline. Following predefined hypotheses, the mean within-arm effect from baseline to primary end point (ie, patient improvement between PAT and open-label TAD trials on the 17-item Hamilton Depression Rating Scale) was compared. To assess the potential role of blinding, the within-arm effect of blinded vs open-label trials in both PAT and TADs was also compared. Of the initially retrieved PubMed 619 records, 24 met inclusion criteria. Contrary to the first of 3 hypotheses, PAT (8 trials; 249 patients) was no more effective than open-label TAD treatment (16 open-label TAD trials; 7921 patients), with an estimated difference of 0.3 favoring open-label TADs (95% CI, -1.39 to 1.98; P = .73). Open-label TADs were associated with better outcomes than blinded treatment (144 blinded TAD trials; 31 792 patients), with an estimated difference of 1.3 (95% CI, 0.07-2.51; P = .04;), but the same difference was not observed for PAT (0.67; 95% CI, -3.08 to 1.73; P = .58). In trials of depression, PAT was not more effective than open-label TADs. Blinding made a difference for TADs, but not for PAT, confirming that PAT trials are effectively always open label. These results argue against highly optimistic narratives surrounding PAT and highlight the importance of blinding integrity.31:Tf7f, Importance Psychedelic-assisted therapy (PAT) trials have high levels of functional unblinding, which biases results when comparing PAT with blinded interventions. Because PAT is effectively always open label, treatment results should be compared with those of open-label traditional antidepressants (TADs), so potential benefits associated with patients knowing their treatment is equal between the interventions. Objective To investigate the comparative effectiveness of PAT vs open-label traditional antidepressants (TADs; such as selective serotonin and norepinephrine reuptake inhibitors) for the treatment of major depression. Data Sources PubMed was systematically searched in March 2024 for trials of PAT and open-label TADs for the treatment of major depression without comorbidity in adults without psychosis in the outpatient setting. Extraction was supplemented with data from a review and meta-analysis of antidepressant drugs to assess the open-label vs blinded TAD difference. Data Extraction and Synthesis Depression scores were extracted by 2 independent reviewers; estimates were pooled with both bayesian and frequentist mixed-effects models. Reporting follows the PRISMA guideline. Main Outcomes and Measure Following predefined hypotheses, the mean within-arm effect from baseline to primary end point (ie, patient improvement between PAT and open-label TAD trials on the 17-item Hamilton Depression Rating Scale) was compared. To assess the potential role of blinding, the within-arm effect of blinded vs open-label trials in both PAT and TADs was also compared. Results Of the initially retrieved PubMed 619 records, 24 met inclusion criteria. Contrary to the first of 3 hypotheses, PAT (8 trials; 249 patients) was no more effective than open-label TAD treatment (16 open-label TAD trials; 7921 patients), with an estimated difference of 0.3 favoring open-label TADs (95% CI, −1.39 to 1.98; P = .73). Open-label TADs were associated with better outcomes than blinded treatment (144 blinded TAD trials; 31 792 patients), with an estimated difference of 1.3 (95% CI, 0.07-2.51; P = .04;), but the same difference was not observed for PAT (0.67; 95% CI, −3.08 to 1.73; P = .58). Conclusions and Relevance In trials of depression, PAT was not more effective than open-label TADs. Blinding made a difference for TADs, but not for PAT, confirming that PAT trials are effectively always open label. These results argue against highly optimistic narratives surrounding PAT and highlight the importance of blinding integrity. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Psychedelic-Assisted Therapy: modality Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Psychedelic-Assisted Therapy (modality). Clinician-written summaries and actionable practice insights. 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All summary content is inferred from the title and journal context alone. Key details such as specific regulatory criteria, cited evidence, affected drug classes, and clinical implications could not be extracted and may differ from the article's actual content.","value_numeric":null},{"paper_doi":"10.1056/nejmsb2609286","tag_type":"warning","value":"The study design tag 'Policy/Regulatory Analysis' is an inference from the title; the article may be an editorial, perspective, or special report — exact format is unconfirmed.","value_numeric":null}],"summaries":{"what_studied":"This article describes the FDA's newly proposed regulatory framework for psychedelic drugs, addressing how these substances might be evaluated, approved, and monitored for therapeutic use.","key_result":"The FDA outlined a structured approach for the development and potential approval of psychedelic therapies, though specific numerical outcomes or trial results are not reported in the available metadata.","limitations":"The source text provided contains only metadata (title, DOI, journal, date) without the full article body, limiting extraction of specific regulatory details, evidence cited, or quantitative findings.","practice_takeaway":"Clinicians working in psychiatry or addiction medicine should monitor evolving FDA guidance on psychedelics, as new frameworks may shape how these therapies enter clinical practice in the near term."}},{"doi":"10.1001/jamanetworkopen.2026.30608","pmid":"42616497","title":"Safety and Mental Health Outcomes of Oregon State-Regulated Psilocybin Services","journal_title":"JAMA Network Open","journal_issn":"2574-3805","published_at":"2026-08-19T00:00:00.000Z","url":"https://doi.org/10.1001/jamanetworkopen.2026.30608","source_score":576,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-08-24T06:18:13.182Z","updated_at":"2026-08-24T06:18:13.182Z","tags":[{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"category","value":"Medicine, General & Internal","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"condition","value":"Anxiety","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"condition","value":"Depression","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"condition","value":"Post-Traumatic Stress Disorder","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"generic","value":"psilocybin","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"modality","value":"Psychedelic-Assisted Therapy","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"sample_size","value":"n=346","value_numeric":346},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"study_design","value":"Prospective Cohort Study","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"warning","value":"Adverse behavioral reactions were statistically significant per the abstract, but the absolute rate (1.2%) is low; clinical significance of this rate in broader implementation contexts is uncertain.","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"warning","value":"Dose information was facilitator-reported; participant-reported outcomes were self-assessed with no independent verification.","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"warning","value":"No control or comparator group was used; pre-to-post improvements cannot be attributed to psilocybin alone due to potential expectancy, placebo, and regression-to-the-mean effects.","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"warning","value":"The sample is not representative of the general population—it skews White, highly educated, and high-income, which substantially limits generalizability.","value_numeric":null},{"paper_doi":"10.1001/jamanetworkopen.2026.30608","tag_type":"warning","value":"The study covers only up to 3 months of follow-up for primary outcomes; longer-term safety and durability of mental health benefits are not yet reported.","value_numeric":null}],"summaries":{"what_studied":"This multisite cohort study (OPEN) enrolled 346 adults receiving Oregon state-regulated psilocybin services at 24 licensed centers (Nov 2024–Mar 2026), supervised by 83 facilitators. It tracked safety events, and participant-reported depression (PHQ-9), anxiety (HADS), PTSD (PCL-6), mental well-being, and life satisfaction at baseline, 1 week, 1 month, and 3 months post-session.","key_result":"Serious adverse behavioral reactions requiring medical attention occurred in 4 of 346 participants (1.2%), all psychedelic-naive. At 3 months, moderate-to-severe depression fell by 60% (RR 0.40; 95% CI 0.32–0.50), anxiety by 71% (RR 0.29; 95% CI 0.22–0.38), and PTSD symptoms by 65% (RR 0.35; 95% CI 0.27–0.45) vs. baseline. Life satisfaction improved (RR 1.31; 95% CI 1.19–1.44) and mental well-being scores rose by 3.21 points (95% CI 2.66–3.76). At 1 month, 92.2% reported benefit and 58.6% ranked the session among the 10 most meaningful experiences of their life.","limitations":"- No control group; pre–post changes may partly reflect regression to the mean, natural history, or expectancy effects.\n- Sample was highly educated (76.6% college graduates), predominantly White (86.7%), and high-income (29% >$200K/year), limiting generalizability.\n- Outcomes are entirely self-reported; no blinding or independent outcome verification.","practice_takeaway":"In this real-world Oregon cohort, regulated psilocybin sessions appeared safe for most adults, with serious adverse reactions concentrated in psychedelic-naive users—clinicians counseling patients considering these services should flag psychedelic-naive status as a key risk factor. Large self-reported improvements in depression, anxiety, and PTSD are encouraging but must be interpreted cautiously given the uncontrolled design."}},{"doi":"10.1007/s12671-026-02957-w","pmid":null,"title":"Perspectives on Meditation-based Preparation for Psychedelic Experiences: Insights from Practitioners with Combined Meditation and Psychedelic Experience","journal_title":"Mindfulness","journal_issn":"1868-8527","published_at":"2026-08-15T00:00:00.000Z","url":"https://doi.org/10.1007/s12671-026-02957-w","source_score":8,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":false,"crossref":true,"unpaywall":true},"created_at":"2026-08-21T06:28:05.999Z","updated_at":"2026-08-21T06:28:05.999Z","tags":[{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"category","value":"Psychology, Clinical","value_numeric":null},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"condition","value":"Mental Health","value_numeric":null},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"condition","value":"Psychedelic Experience Preparation","value_numeric":null},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"level_of_evidence","value":"4","value_numeric":null},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"modality","value":"Meditation","value_numeric":null},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"modality","value":"Psychedelic-Assisted Therapy","value_numeric":null},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"sample_size","value":"n=123","value_numeric":123},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"study_design","value":"Cross-Sectional Survey","value_numeric":null},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"warning","value":"The full text pages appear to be blank in the provided document — all structured data was extracted exclusively from the abstract. Findings may be more nuanced in the full paper.","value_numeric":null},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"warning","value":"The PBMPP scale appears to be a study-specific measure; its psychometric validation status is unclear from the abstract alone.","value_numeric":null},{"paper_doi":"10.1007/s12671-026-02957-w","tag_type":"warning","value":"The sample is 66.7% male and self-selected from online sources, which may limit representativeness across sex and geography despite the 24-country reach.","value_numeric":null}],"summaries":{"what_studied":"This cross-sectional online survey examined how experienced meditators (n=123, mean age 41.1 years, 24 countries) perceive meditation as a preparatory tool for psychedelic experiences, including which practices, formats, and durations they consider most beneficial.","key_result":"Loving-Kindness Meditation was rated the most beneficial preparatory practice over Focused Attention. Three underlying factors were identified: Positive Emotional States (PES), Mindful Awareness and Insight (MAI), and Concentration Techniques (CT) — with PES receiving strongest endorsement. Tradition adherence boosted perceived benefit for less experienced meditators (1–3 years), but reversed for those with 10+ years of practice. Participants recommended ~3 weeks of preparation with 30-min daily sessions, preferring online/asynchronous delivery.","limitations":"Self-selected sample limits generalizability; the study is cross-sectional and retrospective, relying entirely on self-report; no objective or clinical outcomes were measured — perceived benefits do not confirm actual efficacy.","practice_takeaway":"When preparing patients for psychedelic-assisted therapy, consider incorporating Loving-Kindness Meditation and positive emotional cultivation over pure concentration techniques. Tailor preparation intensity and tradition structure to the patient's prior meditation experience — beginners may benefit more from structured, tradition-based guidance."}},{"doi":"10.1177/02698811261464988","pmid":"42460632","title":"Silence is golden: Documenting the speech production of participants and support providers in psilocybin administration sessions for the treatment of post-traumatic stress disorder","journal_title":"Journal of Psychopharmacology","journal_issn":"0269-8811","published_at":"2026-07-16T00:00:00.000Z","url":"https://doi.org/10.1177/02698811261464988","source_score":78,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-07-20T13:36:07.259Z","updated_at":"2026-07-20T13:36:07.259Z","tags":[{"paper_doi":"10.1177/02698811261464988","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"brand","value":"COMP360","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"category","value":"Neurosciences","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"category","value":"Psychiatry","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"condition","value":"Post-Traumatic Stress Disorder","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"generic","value":"psilocybin","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"modality","value":"Psychedelic-Assisted Therapy","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"sample_size","value":"n=22","value_numeric":22},{"paper_doi":"10.1177/02698811261464988","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"study_design","value":"Mixed-Methods Clinical Trial Analysis","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"warning","value":"Level of evidence rated '3' reflecting a secondary analysis of a small single-arm trial with qualitative components.","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"warning","value":"Sex breakdown of the 22 participants is not reported in the abstract; 'mixed' is assumed.","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"warning","value":"Study design tag is approximate — the paper combines quantitative speech analysis of a clinical trial with qualitative thematic analysis; it is not a primary RCT report but a secondary/process analysis of trial data.","value_numeric":null},{"paper_doi":"10.1177/02698811261464988","tag_type":"warning","value":"The impact_flag 'practice_changing' is applied cautiously given the very small sample size, but the finding about silent/non-directive support as a distinct model from conventional psychotherapy is a clinically meaningful paradigm distinction.","value_numeric":null}],"summaries":{"what_studied":"This study analyzed audio transcripts from a 12-week clinical trial of 25 mg COMP360 psilocybin in 22 adults with PTSD (NCT05312151) to quantify speech rates (words-per-minute) for participants and support providers across session types, and conducted thematic analysis of post-dosing interviews to understand how support was experienced.","key_result":"During psilocybin administration sessions, 78% of time was filled with silence — compared to only 25–30% silence in preparation and follow-up sessions — indicating that verbal interaction was rare. Three themes emerged: support was minimally enacted but experientially salient; autonomy was promoted by the introspective state and non-directive support; and reassurance/validation were the primary support modes during altered states.","limitations":"Very small sample (n=22); single-trial data from one sponsor (Compass Pathfinder) limits generalizability; qualitative thematic analysis is inherently interpretive and subject to researcher bias.","practice_takeaway":"In psilocybin-assisted therapy for PTSD, the support role during dosing sessions is largely silent and non-directive — quite different from conventional psychotherapy or MDMA-assisted therapy. Clinicians and trial designers should expect that effective monitoring and support in this model requires comfort with extended silence, focused presence, and brief reassurance rather than active verbal intervention."}},{"doi":"10.1192/bjp.2026.10687","pmid":"42414058","title":"Psilocybin therapy for adult females with anorexia nervosa: pilot study","journal_title":"The British Journal of Psychiatry","journal_issn":"0007-1250","published_at":"2026-07-08T00:00:00.000Z","url":"https://doi.org/10.1192/bjp.2026.10687","source_score":70,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-07-14T13:24:21.508Z","updated_at":"2026-07-14T13:24:21.508Z","tags":[{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"brand","value":"COMP360","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"category","value":"Psychiatry","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"condition","value":"Anorexia Nervosa","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"generic","value":"psilocybin","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"level_of_evidence","value":"4","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"modality","value":"Psychedelic-Assisted Therapy","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"sample_size","value":"n=21","value_numeric":21},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"sex","value":"female","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"study_design","value":"Single-Arm Pilot Study","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"warning","value":"COMPASS Pathways (manufacturer of COMP360) provided the investigational drug; several authors report consulting relationships with psychedelic industry companies, representing a potential conflict of interest.","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"warning","value":"Participants discontinued SSRIs prior to dosing; SSRI withdrawal itself may have contributed to symptom changes and confounds efficacy interpretation.","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"warning","value":"The 1 mg dose was used as an active placebo comparator within a within-individual design, but was not statistically distinguishable from 25 mg doses, complicating dose-response interpretation.","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"warning","value":"The study is single-arm with no placebo or active control group; efficacy results cannot be attributed solely to psilocybin versus talk therapy, medication withdrawal, or natural course of illness.","value_numeric":null},{"paper_doi":"10.1192/bjp.2026.10687","tag_type":"warning","value":"Two serious adverse events (suicide attempts) occurred in one participant 7–9 months post-dosing; causality was deemed unlikely but cannot be fully excluded in this vulnerable population.","value_numeric":null}],"summaries":{"what_studied":"This single-arm, single-blind pilot study evaluated the safety, feasibility, and potential efficacy of three oral psilocybin (COMP360) dosing sessions (1 mg, 25 mg, 25 mg) over 6 weeks—alongside talk therapy and treatment as usual—in 21 adult females with treatment-resistant anorexia nervosa, with follow-up to 12 months.","key_result":"Psilocybin was well tolerated (most common AEs: headache 85.7%, nausea 57.1%, dizziness). Eating disorder symptoms improved significantly from baseline (EDE: p<0.0001, d=0.98 at 6 months); motivation to change improved and was sustained at 12 months (RMQ: p=0.0017, d=0.65). At 3-month follow-up, 47.6% of participants reached community-norm ('remission') range. Two serious adverse events (suicide attempts by one participant) occurred between months 6–12, deemed unlikely to be drug-related.","limitations":"- No control group; single-arm, fixed-order design prevents attribution of benefit to psilocybin specifically vs. talk therapy or time.\n- Small, homogenous sample (76% White British, highly educated, all female), limiting generalizability.\n- EDE interviewer was not blinded to dosing regimen, introducing assessment bias.","practice_takeaway":"For clinicians treating adults with severe, treatment-resistant anorexia nervosa, this pilot signals that psilocybin-assisted therapy appears feasible and safe in the short term, with meaningful symptom improvements—but the single-arm design means it cannot yet be recommended outside of controlled research settings. Larger, randomized trials with active comparators are needed before clinical adoption."}},{"doi":"10.1001/jamapsychiatry.2025.4809","pmid":"41848744","title":"Psychedelic Therapy vs Antidepressants for the Treatment of Depression Under Equal Unblinding Conditions","journal_title":"JAMA Psychiatry","journal_issn":"2168-622X","published_at":"2026-03-18T00:00:00.000Z","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13000746/","source_score":279,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2026-05-11","doi":"10.1001/jamapsychiatry.2025.4809","days":"7","issn":"2168-622X","rank":"4","field":"Clinical Medicine","score":"279","category":"Psychiatry","categories":["Psychiatry"],"_categories":["Psychiatry"]},"pubmed":{"doi":"10.1001/jamapsychiatry.2025.4809","title":"Psychedelic Therapy vs Antidepressants for the Treatment of Depression Under Equal Unblinding Conditions: A Systematic Review and Meta-Analysis.","journal":"JAMA psychiatry","methods":"","results":"Of the initially retrieved PubMed 619 records, 24 met inclusion criteria. Contrary to the first of 3 hypotheses, PAT (8 trials; 249 patients) was no more effective than open-label TAD treatment (16 open-label TAD trials; 7921 patients), with an estimated difference of 0.3 favoring open-label TADs (95% CI, -1.39 to 1.98; P = .73). Open-label TADs were associated with better outcomes than blinded treatment (144 blinded TAD trials; 31 792 patients), with an estimated difference of 1.3 (95% CI, 0.07-2.51; P = .04;), but the same difference was not observed for PAT (0.67; 95% CI, -3.08 to 1.73; P = .58).","abstract":"$30","keywords":[],"pubmed_id":"41848744","conclusions":"","publication_date":"2026-03-18T00:00:00"},"crossref":{"DOI":"10.1001/jamapsychiatry.2025.4809","URL":"https://doi.org/10.1001/jamapsychiatry.2025.4809","ISSN":["2168-622X"],"link":[{"URL":"https://jamanetwork.com/journals/jamapsychiatry/articlepdf/2846479/jamapsychiatry_williams_2026_oi_250081_1777052925.93618.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":"461","type":"journal-article","issue":"5","score":1,"title":["Psychedelic Therapy vs Antidepressants for the Treatment of Depression Under Equal Unblinding Conditions"],"author":[{"given":"Zachary J.","family":"Williams","sequence":"first","affiliation":[{"name":"Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles"},{"name":"Frist Center for Autism and Innovation, Vanderbilt University School of Engineering, Nashville, Tennessee"},{"name":"A.J. 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Accessed March 28, 2025. https://www.globenewswire.com/news-release/2025/02/03/3019385/0/en/GH-Research-Announces-Primary-Endpoint-Met-in-Phase-2b-Trial-with-GH001-in-TRD-Demonstrating-15-5-Point-Placebo-adjusted-MADRS-Reduction.html","article-title":null,"journal-title":null,"doi-asserted-by":null}],"short-title":[],"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,5,1]]}},"content-domain":{"domain":[],"crossmark-restriction":false},"original-title":[],"container-title":["JAMA Psychiatry"],"published-print":{"date-parts":[[2026,5,1]]},"reference-count":63,"published-online":null,"references-count":63,"short-container-title":["JAMA Psychiatry"],"is-referenced-by-count":3},"unpaywall":{"doi":"10.1001/jamapsychiatry.2025.4809","is_oa":true,"title":"Psychedelic Therapy vs Antidepressants for the Treatment of Depression Under Equal Unblinding Conditions","updated":"2026-03-22T08:27:26+00:00","published_date":"2026-03-18","best_oa_location":{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13000746/","pmh_id":"oai:pubmedcentral.nih.gov:13000746","url_for_pdf":null,"url_for_landing_page":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13000746/"}}},"created_at":"2026-05-12T13:18:06.315Z","updated_at":"2026-05-14T15:13:26.918Z","tags":[{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"category","value":"Psychiatry","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"condition","value":"Major Depressive Disorder","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"level_of_evidence","value":"1","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"modality","value":"Psychedelic-Assisted Therapy","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"modality","value":"Selective Serotonin Reuptake Inhibitor","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"modality","value":"Serotonin-Norepinephrine Reuptake Inhibitor","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"sample_size","value":"n=39962","value_numeric":39962},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"study_design","value":"Systematic Review and Meta-Analysis","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"warning","value":"Full text is under PMC embargo until March 18, 2027; summary is based on the abstract only — detailed methodology, subgroup analyses, and full results tables were not accessible.","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"warning","value":"The impact_flag 'practice_changing' is applied cautiously — the null result challenges prevailing optimism about PAT, but broader clinical adoption of PAT is not yet established.","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"warning","value":"The PAT arm sample (n=249 across 8 trials) is substantially smaller than the TAD comparator groups, which may affect the robustness of the null finding.","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4809","tag_type":"warning","value":"Total sample size (n=39,962) is an approximate sum of all arms across all trial types as reported in the abstract; individual patient overlap across trial pools cannot be verified without full text.","value_numeric":null}],"summaries":{"what_studied":"This systematic review and meta-analysis compared the effectiveness of psychedelic-assisted therapy (PAT) vs open-label traditional antidepressants (TADs; e.g., SSRIs/SNRIs) for major depression in adults, using equal unblinding conditions as a control for expectancy bias. 24 trials were included (8 PAT trials, n=249; 16 open-label TAD trials, n=7,921; 144 blinded TAD trials, n=31,792).","key_result":"PAT was no more effective than open-label TADs on the 17-item Hamilton Depression Rating Scale (estimated difference: 0.3 points favoring open-label TADs; 95% CI, −1.39 to 1.98; P=.73). Open-label TADs outperformed blinded TADs (difference: 1.3 points; 95% CI, 0.07–2.51; P=.04), but this open-label advantage was not seen for PAT (difference: 0.67; 95% CI, −3.08 to 1.73; P=.58), confirming PAT trials are effectively always open label.","limitations":"- PAT arm was small (only 8 trials, n=249), limiting statistical power for precise comparisons.\n- Indirect comparison across separate trial populations introduces potential confounding (patient selection, setting, adjunctive therapy).\n- Full text was under embargo; analysis relies on abstract-level data.","practice_takeaway":"When compared under equal unblinding conditions, PAT shows no meaningful advantage over open-label antidepressants for major depression — clinicians should weigh this against the highly optimistic narratives often cited for PAT. Blinding integrity in PAT trials remains a core methodological concern that should inform how PAT trial results are interpreted."}}],"initialOffset":6,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"modality","value":"Psychedelic-Assisted Therapy"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Modalities","href":"/hub/tag/modality"},{"name":"Psychedelic-Assisted Therapy"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"modality","hub_tag_value":"Psychedelic-Assisted Therapy"}}}]]

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