Trial reportPsychiatry and clinical neurosciences2023
Efficacy and safety of zuranolone in Japanese adults with major depressive disorder: A double-blind, randomized, placebo-controlled, phase 2 clinical trial.
Trial report in Psychiatry and clinical neurosciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 6 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 6 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- The efficacy and safety of Zuranolone for treatment of depression: A systematic review and meta-analysis.Psychopharmacology · 2024Pooled it
- The efficacy of zuranolone versus placebo in postpartum depression and major depressive disorder: a systematic review and meta-analysis.International journal of clinical pharmacy · 2024Pooled it
- Zuranolone for treatment of major depressive disorder: a systematic review and meta-analysis.Frontiers in neuroscience · 2024Pooled it
- Evaluating the safety and efficacy of zuranolone in the management of major depressive disorder and postpartum depression, with or without concurrent insomnia: a rigorous systematic review and meta-analysis.Frontiers in psychiatry · 2024Pooled it
- Efficacy and safety of zuranolone in the treatment of major depressive disorder: a meta-analysis.Frontiers in neuroscience · 2023Pooled it
- Efficacy and tolerability of zuranolone in patients with depression: a meta-analysis of randomized controlled trials.Frontiers in pharmacology · 2023Pooled it
- Efficacy and safety of zuranolone in Japanese adults with major depressive disorder: A double-blind, randomized, placebo-controlled, Phase 3 clinical trial.Psychiatry and clinical neurosciences · 2026Trial
- Response to Durability of zuranolone in postpartum depression versus major depressive disorder.Psychiatry and clinical neurosciences · 2026Article
- Analysis of depressive symptom trajectory patterns with zuranolone: Time-series clustering of Japanese Phase 2 and Phase 3 trial data.PCN reports : psychiatry and clinical neurosciences · 2026Article
- Safety and efficacy of zuranolone in Japanese adults with major depressive disorder: An open-label, repeated-treatment part of a Phase 3 clinical trial.PCN reports : psychiatry and clinical neurosciences · 2026Article
- Peripartum Depression Pharmacotherapies Targeting GABA-Glutamate Neurotransmission.Journal of clinical medicine · 2025Review
- Clinical Utility of Zuranolone for Postpartum Depression: A Narrative Review.Neuropsychiatric disease and treatment · 2025Review
- Current Developments in the Treatment of Postpartum Depression: Zuranolone.The Eurasian journal of medicine · 2024Article
- Differential effects of allopregnanolone and diazepam on social behavior through modulation of neural oscillation dynamics in basolateral amygdala and medial prefrontal cortex.Frontiers in cellular neuroscience · 2024Article
- Efficacy and safety of zuranolone in major depressive disorder: a meta-analysis of factor effect and dose-response analyses.EClinicalMedicine · 2023Article
- Zuranolone: First Approval.Drugs · 2023Review
- Exploring Novel Therapeutic Approaches for Depressive Disorders: The Role of Allopregnanolone Agonists.Cureus · 2023Review
- Distinct mechanisms of allopregnanolone and diazepam underlie neuronal oscillations and differential antidepressant effect.Frontiers in cellular neuroscience · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 1 country.
Funding
Abstract
aimTo evaluate the efficacy and safety of an oral, once-daily, 14-day treatment course of zuranolone in Japanese patients with major depressive disorder (MDD).
methodsThis multicenter, randomized, double-blind, placebo-controlled study randomized eligible patients (1:1:1) to receive oral zuranolone 20 mg, zuranolone 30 mg, or placebo once daily for 14 days (treatment-period), followed by two 6-week follow-up periods. The primary endpoint was change from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17) total score on Day 15.
resultsOverall, 250 patients (enrolled: 07/07/2020-05/26/2021) were randomized to receive placebo (n = 83), zuranolone 20 mg (n = 85), or zuranolone 30 mg (n = 82). The demographic and baseline characteristics were balanced between groups. The adjusted mean (standard error) change from baseline in the HAMD-17 total score on Day 15 was -6.22 (0.62), -8.14 (0.62), and - 8.31 (0.63) in the placebo, zuranolone 20-mg, and zuranolone 30-mg groups, respectively. Significant differences in the adjusted mean (95% confidence interval [CI]) for zuranolone 20 mg versus placebo (-1.92; [-3.65, -0.19]; P = 0.0296) and zuranolone 30 mg versus placebo (-2.09; [-3.83, -0.35]; P = 0.0190) groups were observed on Day 15, and also as early as Day 3. A nonsignificant yet distinct drug-placebo separation was observed during follow-up. Somnolence (placebo [3.7%], zuranolone 20 mg [10.6%], and zuranolone 30 mg [20.7%]) and dizziness (3.7%, 9.4%, and 9.8%, respectively) were more common with zuranolone.
conclusionOral zuranolone was safe and demonstrated significant improvements in depressive symptoms, as assessed by HAMD-17 total score change from baseline over 14 days in Japanese patients with MDD.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.