Trial reportClinical pharmacokinetics2020
SAGE-217, A Novel GABA
Trial report in Clinical pharmacokinetics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
21 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- The efficacy and safety of Zuranolone for treatment of depression: A systematic review and meta-analysis.Psychopharmacology · 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
- Zuranolone for treatment of major depressive disorder: a systematic review and meta-analysis.Frontiers in neuroscience · 2024Pooled it
- Investigational Drugs for the Treatment of Depression (Part 1): Monoaminergic, Orexinergic, GABA-Ergic, and Anti-Inflammatory Agents.Frontiers in pharmacology · 2022Pooled it
- Efficacy and safety of zuranolone co-initiated with an antidepressant in adults with major depressive disorder: results from the phase 3 CORAL study.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024Trial
- Pharmacokinetics, safety, and tolerability of single and multiple doses of zuranolone in Japanese and White healthy subjects: A phase 1 clinical trial.Neuropsychopharmacology reports · 2023Trial
- A phase 1 double-blind, placebo-controlled study of zuranolone (SAGE-217) in a phase advance model of insomnia in healthy adults.Human psychopharmacology · 2022Trial
- Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial.JAMA psychiatry · 2021Trial
- Neuroactive Steroids as Novel Promising Drugs in Therapy of Postpartum Depression-Focus on Zuranolone.International journal of molecular sciences · 2025Review
- Recent advances in the synthesis of antidepressant derivatives: pharmacologic insights for mood disorders.3 Biotech · 2024Review
- Novel neurosteroid therapeutics for post-partum depression: perspectives on clinical trials, program development, active research, and future directions.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024Review
- Supportive care of female hormones in brain health: what and how?Frontiers in pharmacology · 2024Review
- Autophagy and Biomaterials: A Brief Overview of the Impact of Autophagy in Biomaterial Applications.Pharmaceutics · 2023Review
- Understanding the mechanism of action and clinical effects of neuroactive steroids and GABAergic compounds in major depressive disorder.Translational psychiatry · 2023Review
- Role of allopregnanolone-mediated γ-aminobutyric acid A receptor sensitivity in the pathogenesis of premenstrual dysphoric disorder: Toward precise targets for translational medicine and drug development.Frontiers in psychiatry · 2023Review
- GABAkines - Advances in the discovery, development, and commercialization of positive allosteric modulators of GABAPharmacology & therapeutics · 2022Review
- Preclinical characterization of zuranolone (SAGE-217), a selective neuroactive steroid GABANeuropharmacology · 2020Article
- Current and potential pharmacological treatment options for insomnia in patients with alcohol use disorder in recovery.Neuropsychopharmacology reports · 2020Review
- Intravenous brexanolone for postpartum depression: what it is, how well does it work, and will it be used?Therapeutic advances in psychopharmacology · 2020Review
- Pharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options.Frontiers in psychiatry · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSAGE-217, a novel γ-aminobutyric acid A (GABA
methodsIn the SAD study, subjects were randomized 6:2 to a single dose of SAGE-217 or placebo. Doses ranged from 0.25 to 66 mg across nine cohorts. In the MAD study, subjects were randomized 9:3 and received SAGE-217 (15, 30, or 35 mg) or placebo once daily for 7 days. In both studies, PK, maximum tolerated dose (MTD; against predetermined criteria), safety, and tolerability were assessed.
resultsA total of 108 healthy volunteers enrolled in the studies-72 subjects in the SAD study and 36 subjects in the MAD study. SAGE-217 was orally bioavailable, with a terminal-phase half-life of 16-23 h and a t
conclusionsSAGE-217 was generally well tolerated, and its PK profile was well characterized. Based on this profile, SAGE-217 has been advanced into multiple phase II clinical programs and pivotal studies of major depressive disorder and postpartum depression.
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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 OpenQuestion graph.