Mental-health treatments, SSRIs and newer antidepressants

Regulatory change — October 15: MHRA announced clearer antidepressant safety information after a review involving patients, families and independent experts. Updated UK patient information leaflets will include a prominent boxed signpost to suicidal-thought/behavior warnings. Selected leaflets will explicitly use the term post-SSRI sexual dysfunction (PSSD) for symptoms that can persist after treatment stops.

Practical implementation: A patient card is initially available electronically, with a portable printed card expected in or on medicine packaging. A separate supporting safety leaflet is being developed for new and existing patients and is expected in 2027; no month is specified.

Evidence and limitations: This improves communication of existing recognized risks. It is not a newly observed trial safety rate, evidence that every patient will experience persistent symptoms, or proof of a particular PSSD frequency. MHRA says additional research is needed. Antidepressant benefit, diagnosis, age, early treatment changes and withdrawal need individual consideration; patients should not abruptly stop prescribed treatment without clinical advice.

U.S. status: This is UK regulatory communication, not an FDA labeling change. It does not alter U.S. approval or availability.

Next milestone: UK implementation and the supporting leaflet in 2027; withdrawal-communication review is ongoing, with no dependable publication date.

Sources: gov.uk · news release; gov.uk · news release; gov.uk · news release; assets.publishing.service.gov.uk · PDF document.

Remaining gaps: Focused safety and human-program discovery update. MHRA October 15 press release, Drug Safety Update, patient guidance and public assessment report were accessed. Saved named registries were retrieved; broad new-registration discovery returned 596 records, only the first 100 retrieved, so mental-health coverage is explicitly incomplete. Small SAINT memory pilot and LIFU-OCD imaging experiment were reviewed as protocol leads but not promoted to established clinical benefit. Prior PEACE, BALANSYA and WELTRUZA items were deduplicated. No full successful-check advancement.

Informal-source coverage: Targeted indexed Reddit safety/antidepressant searches mostly surfaced personal experiences and secondary reporting. These were not used to estimate PSSD incidence or infer efficacy. MHRA safety changes are an official regulatory communication, not a rumor. No distinct attributable new development rumor selected; full podcast/talk coverage incomplete.

Full coverage record.

First posted: October 9, 2026. PEACE/NCT07868536, University of North Carolina, plans 30 people assigned female at birth, aged 18–45, after sexual assault within the preceding 120 hours. A randomized masked comparison tests one oral 17β-estradiol exposure against matching placebo, with three-month follow-up.

Primary: Enrollment feasibility, retention, acceptability and tolerability. PTSD symptom severity, musculoskeletal pain and biological responses are secondary/preliminary. The study is designed to inform a larger trial, not establish prevention of PTSD or chronic pain.

Safety/status/U.S.: Not yet recruiting, despite an elapsed September 28 estimated start. No comparative benefit or harms data are posted. Established uses of estradiol do not constitute approval for post-traumatic PTSD prevention, and this is a hormone-based approach, not an SSRI or psychedelic.

Next: Confirm actual initiation; March 31, 2028 primary / July 31, 2028 final completion estimates, no promised result date.

Sources: ClinicalTrials.gov · NCT07868536.

Source: Orimed/JAMP's October 1, 2026 launch announcement for BALANSYA escitalopram 2 mg/mL oral solution in Canada. Health Canada's March 4, 2026 monograph establishes the earlier authorization date. A current indexed database summary says marketed; the individual-page web cache still says approved, so exact first-market timing is not conclusively reconciled.

Limits/safety: This is the same SSRI molecule, with liquid measurement flexibility rather than demonstrated superior efficacy, withdrawal outcomes or safety. No new comparative tapering trial was announced. An October 11–12 Reddit lead describes it as the first liquid escitalopram in North America; that assertion is contradicted by older U.S. DailyMed oral-solution labels. The sponsor claims Canada's only solution, which is a narrower geography claim.

U.S.: This Canadian brand/formulation announcement is not a new FDA approval or verified U.S. availability. Existing U.S. escitalopram liquids have separate 1 mg/mL labels. Do not extrapolate Canadian indications or strengths to U.S. products.

Next: Verify Canadian current market status and pharmacy availability; no new efficacy-readout milestone.

Sources: newswire.ca · news release; health-products.canada.ca · source page; pdf.hres.ca · PDF document; DailyMed · prescribing information; reddit.com · news release.

Remaining gaps: Read expanded mental-health scope and 20 named registries. New-study first 100 of 542 matches screened; broad query contains incidental symptom terms and later pages remain unretrieved. Selected post-trauma estradiol human entrant and Canadian liquid escitalopram access update; WELTRUZA approval not duplicated.; Canadian market-date/cache discrepancy not silently resolved. Earlier DISCARD protocol narrative says enrollment began February 18 while registry is stale, but full original protocol publication was inaccessible this pass; keep source conflict/access gap. All anxiety/OCD/PTSD/bipolar/addiction pipeline, long-term SSRI harms and guideline/label updates remain incomplete.

Informal-source coverage: Original/indexed Oct 11–12 liquid-escitalopram posts led to sponsor/Health Canada sources. Their first-North-America claim is contradicted by an older U.S. DailyMed label; no tapering-benefit claim adopted. Wider withdrawal anecdotes and informal drug-timing claims did not establish a selected new rumor; full podcast sweep incomplete.

Full coverage record.

Source date: October 9, 2026 at 7 a.m., before this scheduled check. Evidence: Teva approval announcement and U.S. prescribing information revised October 2026; independent FDA approval letter not retrieved.

WELTRUZA/olanzapine is a monthly subcutaneous formulation for adults with schizophrenia, in 318/425/531 mg strengths. This is an antipsychotic formulation update, not an SSRI or an approval for depression or bipolar disorder. Teva expects U.S. availability in the coming weeks; actual launch and coverage remain unverified.

Clinical evidence: SOLARIS/NCT05693935 randomized 675 adults with acute schizophrenia exacerbations. At week 8, the 425 mg dose improved PANSS versus placebo by 11.27 points (95% CI 7.53–15.01 points in favor of treatment). This placebo comparison does not prove better relapse prevention than oral olanzapine.

Safety: The label reports weight-increase events in 30–39% versus 9% with placebo, somnolence 6–10% versus 2%, and injection-site reactions. Olanzapine's metabolic risks remain; the dementia-related-psychosis mortality boxed warning applies. Oral tolerability should be established when unknown. No required post-injection monitoring does not mean no possible delirium/sedation syndrome.

Teva announcement; approved U.S. label.

Source/event date: First posted October 5, 2026. Evidence: FEAST-AFT/NCT07857122, Centre Hospitalier Sainte-Anne randomized study.

The trial plans 108 adults aged 18–90 with moderate/severe unipolar or bipolar depressive episodes for whom ECT is indicated, randomized to focal electrically administered seizure therapy (FEAST), right-unilateral ECT, or bilateral ECT. Registry masking includes participants, investigators and outcome assessors. The primary endpoint is change in self-reported quality of life/satisfaction five days after acute treatment; depression remission, memory, reorientation time, adverse events and six-month outcomes are tracked separately.

Limits/safety: Not yet recruiting and no new efficacy or safety results. The aim of reducing cognitive effects is not a demonstrated advantage. Rapid-cycling bipolar disorder is excluded; future results must preserve diagnosis, remission, memory and mood-switching outcomes. Device neuromodulation is separate from SSRIs and psychedelics.

U.S. status / next milestone: No new U.S. authorization. November 2, 2026 estimated start; January 2, 2030 primary and July 2, 2030 final completion estimates.

Original registry.

Remaining gaps: Read expanded diagnosis topic/state and saved19 registries. Appraised Oct9 Teva release plus actual45-page approved label for new olanzapine formulation, not an antidepressant claim.; New-study search returned100 with another page not retrieved; broad query contains many incidental depression/trauma terms. FEAST-AFT selected with active-comparator and primary quality-of-life endpoint preserved.; OCD/PTSD/anxiety/addiction/bipolar full pipeline, all SSRI long-term harms and formal label/guideline changes remain incompletely reviewed. WELTRUZA is included explicitly as schizophrenia/formulation-specific within broad mental-health treatment, without antidepressant/bipolar extrapolation.

Informal-source coverage: Targeted original Reddit and new-program informal searches performed. Oct9 WELTRUZA Reddit post traces to public approval release rather than a separate rumor. Older emotional-blunting anecdotes and fluoxetine-reanalysis commentary do not constitute new development signals. Full podcasts/Q&A census incomplete.

Full coverage record.

Source/event date: October 1, 2026 first publication; October 2 Nature news and October 4 Reddit are later reporting. Evidence: Peer-reviewed reappraisal of three pediatric-depression network meta-analyses.

An implausible 40-person 2006 fluoxetine-versus-nortriptyline trial indirectly inflated fluoxetine–placebo estimates. Excluding it reduced the combined 2016-network effect from SMD −0.51 to −0.26 (95% credible interval −0.43 to −0.09), and the 2020-network estimate to −0.29(−0.50 to−0.07), closer to the Cochrane analysis. Negative values favor fluoxetine. The statistical average benefit remains; authors characterize its clinical magnitude as small/unimportant.

Limits: This is a reanalysis of pediatric-depression evidence, not a new trial, proof of zero benefit for every child, an adult-depression result or evidence that a 2006 study caused an earlier approval. Network estimates depend on modeling and study selection. Trustworthiness concerns do not themselves establish proven fabrication or retraction.

Safety/U.S. status: No new adverse-event comparison, FDA action or adopted guideline change is demonstrated by this paper.

Next milestone: Journal/investigator responses and formal guideline reassessment; no announced date.

Full primary paper and Table 4.

Source/event date: September 20, 2026 preprint; recovered October 6, rather than a new October trial. Evidence: Non-peer-reviewed first-in-human randomized crossover study, NCT05147142; primary abstract appraised.

Ten participants with MDD received imaging-guided low-intensity focused ultrasound targeting the right amygdala versus the left somatosensory cortex as an active control; nine completed both sessions. Two 10-minute applications were used. Safety and imaging target engagement were primary; symptoms were secondary/exploratory. Brain perfusion/connectivity findings supported target engagement, but symptom improvement did not differ between conditions. Spontaneous calm/clarity reports and imaging–symptom correlations are exploratory, not demonstrated remission.

Safety: Adverse events were more frequent following amygdala than control sonication (p=.028); one participant clinically worsened and required monitoring. No serious event or concerning neurological/neuropsychological/MRI finding was reported. Tiny acute exposure cannot establish long-term safety.

U.S. status / next milestone: Experimental neuromodulation, distinct from SSRIs; no new U.S. approval. Larger repeated-session controlled trials and peer review are needed; no announced date. Full preprint access was blocked, so detailed tables remain unappraised.

Primary preprint abstract; preprint DOI.

Source/event date: 2026-09-24. Evidence: New human trial registration; October 1 registry refresh.

KOMET (NCT07839338) was first posted September 24 and refreshed October 1. This Indian phase 3 study plans to randomize 220 adults aged 18–65 with moderate-to-severe major depressive episodes in major depressive disorder or bipolar disorder to adjunct oral ketamine or oral midazolam as an active placebo. Nine supervised sessions are planned; the primary outcome is HAM-D depression severity at week 3, with symptom, response/remission, function and safety follow-up through week 4. The registry lists not yet recruiting, with an estimated October 2026 start and October 2029 primary/final completion. There are no results. Short-term symptom change would not establish durable remission; diagnosis-specific outcomes and mood switching matter for bipolar participants. The registration does not create a U.S. approval for oral ketamine in depression.

Next milestone: October 2026 estimated start; October 2029 estimated primary and final completion

ClinicalTrials.gov · NCT07839338.

Source/event date: 2026-09-09. Evidence: Recovered trial-registration addition.

BAARD (NCT07810738) is a newly identified September 9 registration, not an October launch. Washington University plans a masked randomized phase 2 study of 300 adults aged 60 or older with treatment-resistant major depression. A biotype/computer predictive model selects aripiprazole or bupropion augmentation in one group; the comparison group receives a randomly selected one of those same medicines. The primary endpoint is remission (MADRS ≤10) at week 10. Bipolar I/II disorder and dementia are excluded. The October 1 estimated start has passed, but the record still says not yet recruiting; actual initiation is unverified. There are no results establishing that the model improves treatment choice, and these are existing medications rather than a new drug approval.

Next milestone: October 1 2026 start estimate elapsed, verify initiation; March 15 2029 primary and September 15 2029 final completion estimates

ClinicalTrials.gov · NCT07810738.

Source date: 2026-09-28. Evidence: Conference investigator report; prospective observational cohort.

A 20-person treatment-resistant-depression cohort reports improvement after stereotactic radiosurgical capsulotomy, an irreversible lesion-making procedure. Ten participants also had OCD. At median 38.6-month follow-up, 9/18 depression-evaluable participants retained ≥50% BDI improvement; average BDI reduction was 47%. Suicidal ideation was reported in 14/20 before treatment versus 1/20 afterward. Treatment occurred at Vanderbilt, 2020–2025.

Limitations: No control group or causal attribution. Specialized, highly selected population; two participants lacked depression-score evaluation. ASTRO says its release contains updated author data differing from the original abstract. Reduced ideation is not proven suicide prevention.

Safety: Three moderate treatment-related headache/dizziness events; two had larger-than-intended MRI tissue changes. All recovered with steroids. No overall cognitive decline was reported, but 20 participants cannot establish long-term procedural safety.

U.S. status: Specialized investigational evidence; no general treatment recommendation or new drug approval.

Next milestone: Controlled studies and longer safety follow-up are needed; no next trial/readout date announced.

ASTRO September 28 author-updated study release.

Source date: 2026-09-24. Event date: 2026-09-24. Evidence: Sponsor preliminary open-label and subgroup analyses.

Vistagen reported supportive exploratory findings in social anxiety; they do not reverse the randomized PALISADE-4 primary miss announced in June. September 22 OLE: 322 safety participants used intranasal fasedienol as needed. Mean LSAS was 99.3 at baseline (n=320); four-month improvement was 31.4 points (n=197). September 24 presentation highlighted very severe anxiety (baseline LSAS ≥95). The PALISADE-4 post-hoc subgroup (n=123) had SUDS changes −12.8±3.4 versus −3.7±3.4 (SE), difference −9.1, nominal p=.036. A separate small phase-2 repeat-dose subgroup was also highlighted.

Limitations: Uncontrolled OLE, changing denominators and post-hoc subgroup selection limit inference. Some participants had not reached four months at the July cutoff; missing observations are not all treatment discontinuations. Detailed repeat-dose tables were not appraised.

Safety: OLE: adverse-event discontinuations 5/322 (1.6%), none attributed to treatment; headache 58/322 (18%), upper respiratory infection 32/322 (9.9%). No serious event was considered treatment-related; this does not mean no serious events occurred.

U.S. status: Investigational for social anxiety; not an SSRI and not approved.

Next milestone: Sponsor planned FDA discussion in Q3 2026 about another pivotal trial; meeting completion or agreed design not verified.

Vistagen preliminary PALISADE-4 OLE; Vistagen very-severe social-anxiety subgroup presentation.

Related findings:

• Remlifanserin misses Alzheimer psychosis primary endpoint; phase 3 continues.

Source date: 2026-09-21. Event date: 2026-09-18. Evidence: Sponsor conference poster and release; randomized phase 3, not yet a full peer-reviewed report.

Study 451 supports an acute-mania indication, with substantial symptom improvement over three weeks; the original poster also reports serious events and a death. NCT06462586: 354 hospitalized adults with bipolar I mania, with/without mixed features; 177 per arm, lumateperone 42 mg versus placebo. Day-22 YMRS difference −4.8 points (95% CI −6.31 to −3.28; p<.0001). Response (≥50% YMRS decrease) 45.8% versus 20.9%; remission (YMRS≤12) 30.5% versus 16.4%.

Limitations: Three-week treatment and one-week safety follow-up do not establish maintenance/relapse prevention or long-term safety. Sponsor-presented evidence.

Safety: Poster: two serious adverse events and one death in the active arm. The deceased participant had rhabdomyolysis that resolved before death; investigator assessed the death as likely multifactorial, not directly caused by treatment. Other SAE: bipolar disorder. Headache 15.3% vs 7.9%, dry mouth 7.9% vs 3.4%, nausea 7.9% vs 2.3%, somnolence 4.0% vs 1.1%. Do not count the death and preceding SAE as separate patients.

U.S. status: Caplyta is U.S.-approved for schizophrenia, bipolar depression and adjunctive MDD; acute mania remains investigational.

Next milestone: Second pivotal study 452 is completed and under analysis per September 21 release; no readout date announced.

J&J September 21 release; Original Psych Congress poster 72; Study 451 registry.

Source date: 2026-09-19. Event date: 2026-09-19. Evidence: Peer-reviewed sham-controlled proof-of-principle study.

7-Tesla fMRI biofeedback produced a short-lived clinical-factor signal; the primary VTA-activation endpoint did not separate active from sham. NCT04138680: 32 unmedicated MDD participants (17 active/15 sham) plus 30 healthy controls; one training session. Mood/affect latent-factor benefit immediately and at 24 hours, but individual 7- and 30-day comparisons were not statistically significant.

Limitations: Small sample, derived composite and exploratory follow-ups. An omnibus across-time signal does not establish persistent remission; null neural primary endpoint limits mechanism claims.

Safety: No detailed adverse-event analysis found in accessible main article.

U.S. status: Experimental protocol, not a newly authorized depression treatment.

Next milestone: Repeated-session replication needed; no dated follow-up verified.

Original Molecular Psychiatry study; Trial record.

Related findings:

• Bipolar II psilocybin pilot reports improvement and psychiatric adverse events.
• Optimi plans Canadian phase 3 MDMA-assisted PTSD study.
• Optimi plans Canadian phase 2 naturally derived psilocybin study.

Source date: 2026-09-14. Evidence: sponsor topline randomized phase 2.

Contineum reported that MOONLIGHT-1 did not improve Day 5 MADRS significantly versus placebo. Randomized, double-blind monotherapy study in adults with MDD; NCT06785012. Registry actual enrollment 107, completed August 10, last updated August 28, no posted results. The selective M1 inhibitor is licensed to J&J. Prespecified exploratory analyses continue; no program discontinuation was announced.

Limitations: No effect size, confidence interval or P value in topline. A later exploratory signal would not erase the failed primary endpoint.

Safety: Sponsor reports no new safety signal; detailed adverse-event rates not released.

U.S. status: Investigational for MDD.

Next milestone: No announced date: Full results and J&J development decision remain pending.

September 14 issuer release filed with SEC; MOONLIGHT-1 registry.

Source date: 2026-09-17. Evidence: new trial registration.

A newly registered phase 4 study will examine adjunctive lumateperone for emotional blunting in MDD. NCT07824206; Future Options Research with J&J collaboration, planned 30 adults, open-label single group. Eight-week Oxford Depression Questionnaire change is the primary endpoint. Registry status not yet recruiting; September 2026 start remains estimated.

Limitations: No results or comparator. Emotional blunting can reflect illness and treatment; the design cannot isolate a drug-causal explanation or comparative benefit.

Safety: No study safety results yet. Phase 4 designation does not establish benefit for this specific symptom.

U.S. status: Lumateperone has an adjunctive MDD indication, but this specific emotional-blunting claim is being studied.

Next milestone: Registry estimate: Primary completion January 2028; overall completion March 2028. Not promised publication dates.

New September 17 registry.

Source date: 2026-09-17. Evidence: new randomized study registration.

KetSet will compare psychedelic versus biomedical framing while keeping ketamine treatment the same. NCT07824973, Sweden; planned 120 adults with TRD, randomized parallel arms, participants/staff unblinded and outcome assessors masked. Primary endpoint MADRS change at week 12. Both groups receive six infusions; support/context differs. Not yet recruiting, September start estimated.

Limitations: No results. It tests context, not ketamine versus placebo or psilocybin. Registry title says open-label while design clarifies assessor masking.

Safety: Adverse events, discontinuation, suicidality and longer-term hospital outcomes are planned, not demonstrated.

U.S. status: No U.S. approval change; intravenous ketamine depression use remains distinct from intranasal esketamine approval.

Next milestone: Registry estimate: Primary completion December 2029; overall completion August 2030.

KetSet registry, first posted September 17.

Related findings:

• Small psilocybin subgroup study includes personality disorders: A September 16 paper reports a ten-person TRD subgroup with co-occurring personality disorders, usually excluded from psychedelic trials.

Genotype-guided prescribing — ADOPT PGx Depression / NCT05966155. The May 6, 2026 randomized trial included 1,460 adults and children, with the main analysis in 692 people whose drug-metabolism phenotype could affect prescribing. It did not improve the primary depression-symptom outcome at three months: PROMIS score changes were −4.3 versus −4.0 (P=.68). Adverse-effect burden was not significantly improved. Six-month remission favored genotype guidance, 48.3% versus 39.4%, a secondary finding that needs replication and longer follow-up. This is a mixed result about selecting/dosing SSRIs, not a new drug or a test that reliably identifies the best antidepressant for everyone. No dependable next readout date was verified. Peer-reviewed trial; PubMed; registry.

Withdrawal/discontinuation — DISCARD / NCT07393919. This pragmatic randomized study plans 150 adults with remitted depression, comparing linear and hyperbolic tapering with blinded outcome assessment. It includes SSRIs and other antidepressants. The primary outcome combines failure to discontinue with restarting treatment; withdrawal symptoms and clinical relapse are secondary measures. The February 6 registry snapshot says not yet recruiting and estimates primary completion September 30, 2027. A July protocol publication anticipates final follow-up in July 2027, so timing and actual recruitment need reconciliation. Treat 2027 as a provisional completion window, not an announced results date or proof that either strategy is superior. This is research tracking, not an individual tapering plan. Registry; published protocol.

Programs in this section are adjacent to the SSRI question and have different mechanisms. Indication, trial design, adverse effects and durability matter more than novelty alone.

Toludesvenlafaxine / ansofaxine / LY03005 / Ruoxinlin — triple reuptake inhibitor. This blocks serotonin, norepinephrine and dopamine reuptake; it is not a selective SSRI. Approved for MDD in China since November 2022, with ongoing commercialization reported in August 2026. China accepted a generalized-anxiety-disorder application in January 2026 after an eight-week, placebo-controlled Phase 3 trial in 555 patients. The sponsor release is insufficient to establish superiority to existing SSRIs. No firm China decision date or current U.S. approval timetable verified. A 2020 U.S. filing announcement does not establish that an application is actively under review in 2026. China GAD update; August status; historical U.S. filing.

Liafensine / DB104 — triple reuptake inhibitor with biomarker selection. ENLIGHTEN (NCT05113771) randomized 189 ANK3-biomarker-positive patients with treatment-resistant depression. The peer-reviewed Phase 2b report found a six-week placebo-adjusted MADRS benefit of 4.4 points (95% CI 1.3–7.6), following earlier failures in unselected populations. This supports further study in the selected group, not broad superiority or long-term benefit. Denovo describes Phase 3 development in June 2026, but no reliable recruiting confirmation or results date was verified. Published trial; June sponsor update.

Exxua / gepirone ER — 5-HT1A receptor agonist. FDA-approved for adult MDD in 2023 and commercially launched in early 2026. Its pivotal eight-week trials found roughly 2.5 HAMD-17 points of placebo-adjusted benefit. It is not an SSRI; follow whether comparative and post-launch studies substantiate proposed sexual/metabolic tolerability advantages. Dizziness, nausea and QT prolongation remain material limitations. Already available; no firm new comparative-result date verified. FDA evidence; SEC-filed launch confirmation.

Seltorexant — orexin-2 receptor antagonist. Investigational adjunct for MDD with insomnia, mechanistically separate from serotonin reuptake. J&J announces Phase 3 clinical data at Psych Congress, September 15–19, 2026. This is a scheduled presentation, not necessarily a new pivotal primary readout or an approval decision. Review the actual population, comparator, endpoint, effect and safety data when presented. September 8 announcement.

Auvelity / AXS-05 — dextromethorphan–bupropion, not an SSRI. FDA-approved for adult major depressive disorder (MDD). In GEMINI (NCT04019704), six-week MADRS improvement exceeded placebo by 3.9 points (95% CI 1.4–6.4). The separate STRIDE-1 treatment-resistant-depression trial missed its primary endpoint versus bupropion; do not translate the MDD approval into a specific TRD approval or broad superiority to SSRIs. Seizure risk, blood pressure and serotonergic interactions remain relevant. No firm new MDD pivotal-result date verified. Current FDA label; STRIDE-1 results.

Spravato / esketamine — NMDA antagonist. Approved for adult treatment-resistant depression, including monotherapy since January 2025. The four-week randomized monotherapy trial NCT04599855 analyzed 378 participants for efficacy; placebo-adjusted MADRS differences were 5.1 and 6.8 points for the two studied doses. It is a dissociative treatment requiring supervised administration, despite being separate from classic serotonergic psychedelics. Short follow-up and recognizable drug effects limit interpretation. September 15–19, 2026: announced Psych Congress analyses, including anhedonia; a presentation window does not necessarily mean a new pivotal readout. Approval announcement; published trial; September conference announcement.

Zurzuvae / zuranolone — GABA-A neurosteroid. Approved for adult postpartum depression, not general MDD. Pivotal studies NCT04442503 and NCT02978326 found approximately four-point placebo-adjusted HAM-D differences at day 15, with follow-up through day 45. This short-course approach is worth following, with attention to durability, retreatment and sedation/driving impairment. FDA required more evidence for general MDD in August 2023. No dependable broader-MDD decision or readout date verified. FDA pivotal evidence; MDD regulatory outcome.

Important negative programs — navacaprant and aticaprant. These kappa-opioid antagonists are not SSRIs. Neumora discontinued navacaprant on June 15, 2026 after KOASTAL-2 (430 participants) and KOASTAL-3 (422) missed their primary and key secondary endpoints; week-six placebo-adjusted MADRS differences were −0.3 and +0.7 points. J&J discontinued aticaprant's VENTURA program on March 6, 2025 for insufficient efficacy. Retain as setbacks; no further development milestone is announced. Neumora results; J&J statement.