2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/2iy5wruuedsh6.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/00yc7rcvua6a7.js","/_next/static/immutable/chunks/37ktb71aq3480.js","/_next/static/immutable/chunks/2d50b-7eu4558.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/2d6noqpp6ehas.js","/_next/static/immutable/chunks/1sx186c93bpzg.js","/_next/static/immutable/chunks/3dc-1n866s65i.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2w1bvggzb0ga8.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:Tbc9,The phase 2 data presented here support the development of TSND-201 for posttraumatic stress disorder (PTSD), a disorder for which there is a significant unmet need for rapid-acting and effective treatments. TSND-201 (methylone) is a highly selective, rapid-acting neuroplastogen that releases serotonin, norepinephrine, and dopamine without direct activity at 5-hydroxytryptamine (5-HT) 2A receptors that has shown rapid, robust, and long-lasting benefit for preclinical PTSD-related behaviors and has been well tolerated in phase 1 studies of healthy volunteers. To evaluate the efficacy and safety of TSND-201 vs placebo in adults with PTSD. A Study to Assess the Use of Methylone in the Treatment of PTSD (IMPACT-1) part B was a phase 2, multicenter, double-blind, placebo-controlled, 10-week randomized clinical trial of TSND-201 in people with PTSD conducted between November 29, 2023, and February 19, 2025, across 16 sites in the US, UK, and Ireland. Adults aged 18 to 65 years who met DSM-5 criteria for current PTSD and 6 months or more of symptoms (Clinician-Administered PTSD Scales for DSM-5 [CAPS-5] ≥35) were eligible. Participants were randomized 1:1 to receive TSND-201 or placebo. There were 4 once-weekly oral dosing sessions (150 mg followed by 100 mg or placebo). No psychotherapy was provided; however, dosing sessions were monitored by mental health professionals using a nondirective approach. Participants were followed up for 6 weeks after the last dose. The primary end point was change from baseline to day 64 in the CAPS-5 total severity score. Secondary end points included changes in PTSD Checklist for DSM-5 (PCL-5), Sheehan Disability Scale (SDS), and Montgomery-Åsberg Depression Rating Scale (MADRS) scores. Other measures included response (≥50% improvement from baseline), remission (≤11 total severity score), loss of PTSD diagnosis, changes in CAPS-5 symptom clusters, and incidence of treatment-emergent adverse events (TEAEs). Safety was assessed by monitoring adverse events, vital signs, and Columbia-Suicide Severity Rating Scale. Among the 65 participants (mean [SD] age, 43.7 [10.5] years; 39 female [60.0%]), TSND-201 demonstrated significantly greater improvement in CAPS-5 total score than placebo (least-squares mean difference, 9.64; 90% CI, -16.48 to -2.80; P = .01). PCL-5 (-28.46 vs -19.47; LS mean treatment difference, -8.99; 90% CI, -17.81 to -0.17), SDS (-8.29 vs -3.57; LS mean treatment difference, -4.72; 90% CI, -8.84 to -0.61), and MADRS (-13.94 vs -7.73; LS mean treatment difference, -6.21; 90% CI, -12.41 to -0.27) scores were also improved. Common TEAEs in the TSND-201 group included headache, decreased appetite, nausea, dizziness, blood pressure increased, dry mouth, insomnia. Results of this randomized clinical trial reveal that TSND-201 demonstrated statistically significant efficacy and was well tolerated, supporting its potential as a rapid-acting, durable treatment for PTSD. ClinicalTrials.gov Identifier: NCT05741710.31:T134c, Importance The phase 2 data presented here support the development of TSND-201 for posttraumatic stress disorder (PTSD), a disorder for which there is a significant unmet need for rapid-acting and effective treatments. TSND-201 (methylone) is a highly selective, rapid-acting neuroplastogen that releases serotonin, norepinephrine, and dopamine without direct activity at 5-hydroxytryptamine (5-HT) 2A receptors that has shown rapid, robust, and long-lasting benefit for preclinical PTSD-related behaviors and has been well tolerated in phase 1 studies of healthy volunteers. Objective To evaluate the efficacy and safety of TSND-201 vs placebo in adults with PTSD. Design, Setting, Participants A Study to Assess the Use of Methylone in the Treatment of PTSD (IMPACT-1) part B was a phase 2, multicenter, double-blind, placebo-controlled, 10-week randomized clinical trial of TSND-201 in people with PTSD conducted between November 29, 2023, and February 19, 2025, across 16 sites in the US, UK, and Ireland. Adults aged 18 to 65 years who met DSM-5 criteria for current PTSD and 6 months or more of symptoms (Clinician-Administered PTSD Scales for DSM-5 [CAPS-5] ≥35) were eligible. Interventions Participants were randomized 1:1 to receive TSND-201 or placebo. There were 4 once-weekly oral dosing sessions (150 mg followed by 100 mg or placebo). No psychotherapy was provided; however, dosing sessions were monitored by mental health professionals using a nondirective approach. Participants were followed up for 6 weeks after the last dose. Main Outcomes and Measures The primary end point was change from baseline to day 64 in the CAPS-5 total severity score. Secondary end points included changes in PTSD Checklist for DSM-5 (PCL-5), Sheehan Disability Scale (SDS), and Montgomery-Åsberg Depression Rating Scale (MADRS) scores. Other measures included response (≥50% improvement from baseline), remission (≤11 total severity score), loss of PTSD diagnosis, changes in CAPS-5 symptom clusters, and incidence of treatment-emergent adverse events (TEAEs). Safety was assessed by monitoring adverse events, vital signs, and Columbia-Suicide Severity Rating Scale. Results Among the 65 participants (mean [SD] age, 43.7 [10.5] years; 39 female [60.0%]), TSND-201 demonstrated significantly greater improvement in CAPS-5 total score than placebo (least-squares mean difference, 9.64; 90% CI, −16.48 to −2.80; P = .01). PCL-5 (−28.46 vs −19.47; LS mean treatment difference, −8.99; 90% CI, −17.81 to −0.17), SDS (−8.29 vs −3.57; LS mean treatment difference, −4.72; 90% CI, −8.84 to −0.61), and MADRS (−13.94 vs −7.73; LS mean treatment difference, −6.21; 90% CI, −12.41 to −0.27) scores were also improved. Common TEAEs in the TSND-201 group included headache, decreased appetite, nausea, dizziness, blood pressure increased, dry mouth, insomnia. Conclusions and Relevance Results of this randomized clinical trial reveal that TSND-201 demonstrated statistically significant efficacy and was well tolerated, supporting its potential as a rapid-acting, durable treatment for PTSD. 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Trial","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4625","tag_type":"warning","value":"No response rate (≥50% improvement) or remission (CAPS-5 ≤11) absolute numbers were reported in the abstract despite being listed as secondary endpoints — magnitude of clinical benefit at the individual level is unclear.","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4625","tag_type":"warning","value":"Publication date (2026-02-18) is in the future relative to typical indexing; verify access and final publication status before citing.","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4625","tag_type":"warning","value":"The 90% CI (not the conventional 95%) was used for all efficacy endpoints, which may overstate precision — clinicians should note this non-standard reporting when interpreting significance.","value_numeric":null},{"paper_doi":"10.1001/jamapsychiatry.2025.4625","tag_type":"warning","value":"TSND-201 (methylone) is a controlled substance; regulatory status and scheduling implications for clinical use are not addressed in the abstract.","value_numeric":null}],"summaries":{"what_studied":"Phase 2 double-blind RCT (IMPACT-1 part B) evaluating TSND-201 (methylone, a neuroplastogen) vs placebo in 65 adults aged 18–65 with DSM-5 PTSD (CAPS-5 ≥35, symptoms ≥6 months) across 16 US/UK/Ireland sites; 4 once-weekly oral sessions (150 mg + 100 mg) with 6-week follow-up, no formal psychotherapy.","key_result":"TSND-201 produced significantly greater CAPS-5 improvement vs placebo at day 64 (LS mean difference −9.64; 90% CI −16.48 to −2.80; P=.01). Secondary measures also favored TSND-201: PCL-5 (−28.46 vs −19.47), SDS (−8.29 vs −3.57), and MADRS (−13.94 vs −7.73). Common adverse events included headache, decreased appetite, nausea, dizziness, elevated blood pressure, dry mouth, and insomnia.","limitations":"- Small sample (n=65) limits power and generalizability.\n- No psychotherapy comparator arm; nondirective monitoring during sessions may itself be therapeutic and confound results.\n- 10-week trial with 6-week post-dose follow-up only; long-term durability and safety beyond this window are unknown.","practice_takeaway":"TSND-201 (methylone) showed statistically significant and clinically meaningful PTSD symptom reduction over ~10 weeks with an acceptable short-term safety profile, but this is a small phase 2 trial — phase 3 data are needed before clinical adoption. Monitor blood pressure and watch for sympathomimetic adverse effects during dosing sessions."}}],"initialOffset":1,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"brand","value":"TSND-201"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Brands","href":"/hub/tag/brand"},{"name":"TSND-201"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"brand","hub_tag_value":"TSND-201"}}}]]

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