Trial reportTranslational psychiatry2023
A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to verify the efficacy and safety of ansofaxine (LY03005) for major depressive disorder.
Trial report in Translational psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04853407 (A Phase III, A Multicenter, Double-blind, Randomized, Placebo-controlled Study Verify the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets for Major Depressive Disorder), which is not on this map. Cited by 14 papers.
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.
A Phase III, A Multicenter, Double-blind, Randomized, Placebo-controlled Study Verify the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets for Major Depressive Disorder
Who cites it
14 citing papers in PubMed, 19 citations in OpenAlex.
- Efficacy and safety of Toludesvenlafaxine extended-release tablets in the treatment of treatment-resistant depression.BMC psychiatry · 2025Trial
- Efficacy and Safety of Ammoxetine in Major Depressive Disorder: A Randomized Clinical Trial.JAMA network open · 2025Trial
- Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-Release Tablets on Somatic Symptoms of Major Depressive Disorder: A Prospective, Single-Arm, Multicenter Clinical Study.Neuropsychiatric disease and treatment · 2025Trial
- Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-Release Tablets in Depression With Anhedonia: A Single-Arm, Multicenter Clinical Study.Depression and anxiety · 2025Trial
- Structural basis for pharmacotherapeutic action of triple reuptake inhibitors.Nature communications · 2025Article
- Pharmacological Monotherapy for Depressive Disorders: Current and Future-A Narrative Review.Medicina (Kaunas, Lithuania) · 2025Review
- Anhedonia: Current and future treatments.PCN reports : psychiatry and clinical neurosciences · 2025Review
- Emerging Medications for Treatment-Resistant Depression: A Review with Perspective on Mechanisms and Challenges.Brain sciences · 2025Review
- Current Trends in Clinical Trials of Prodrugs.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in depression with ineffective or partially effective initial antidepressant treatment: a single-arm, multicenter clinical study.Frontiers in psychiatry · 2025Article
- Anxiety disorders, PTSD and OCD: systematic review of approved psychiatric medications (2008-2024) and pipeline phase III medications.Drugs in context · 2025Review
- PET/CT study of dopamine transporter (DAT) binding with the triple reuptake inhibitor toludesvenlafaxine in rats and humans.European journal of nuclear medicine and molecular imaging · 2024Article
- Optimizing Treatment for Major Depressive Disorder in Adolescents: The Impact of Intradermal Acupuncture - A Randomized Controlled Trial Protocol.Neuropsychiatric disease and treatment · 2023Article
- A 6-week, phase IIb, randomized, double-blind, placebo-controlled trial of Anyu Peibo capsules for the treatment of major depressive disorder in adults.Therapeutic advances in psychopharmacology · 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
25 authors at 20 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Major depressive disorder (MDD) is the most prevalent form of depression and is becoming a great challenge for public health and medical practice. Although first-line antidepressants offer therapeutic benefits, about 35% of depressed patients are not adequately treated, creating a substantial unmet medical need. A multicenter, double-blind, randomized, placebo-controlled phase 3 clinical trial was conducted in patients with MDD in China to assess the efficacy and safety of ansofaxine (LY03005), a potential triple reuptake inhibitor of serotonin, norepinephrine, and dopamine. Eligible 588 MDD patients were included and randomly assigned (1:1:1) to 8-week treatment with ansofaxine 80 mg/day(n = 187), ansofaxine 160 mg/day(n = 186), or placebo(n = 185). The primary efficacy endpoint was the Montgomery-Åsberg Depression Rating Scale (MADRS) total score change from baseline to the end of the study. Safety indexes included adverse events, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), and evaluation of suicide tendency and sexual function. Significant differences were found in mean changes in MADRS total score at week 8 in the two ansofaxine groups (80 mg, -20.0; 160 mg, -19.9) vs. placebo (-14.6; p < 0.0001). All doses of ansofaxine were generally well-tolerated. Treatment-emergent adverse events (TEAEs) were reported by 137 (74.46%) patients in ansofaxine 80 mg group, 144 (78.26%) patients in ansofaxine 160 mg and 125 (67.93%) patients in the placebo group. The incidence of treatment-related adverse events (TRAEs) was 59.2% (109 patients), 65.22% (120 patients) in the 80, 160 mg ansofaxine groups, and 45.11% (83 patients) in the placebo group. The initial results of this trial indicate that ansofaxine at both the 80 mg/day and 160 mg/day was effective and safe in adult patients with MDD. ClinicalTrials.gov Identifier: NCT04853407.
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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.