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Background Antidepressant Therapy / Major Depressive Disorder With Psychotic Features / Lurasidone · Phase 3 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized, placebo-controlled trial registration evaluating lurasidone as adjunctive therapy for major depressive disorder with inadequate antidepressant response. No results are reported in this registry record; the study has not yet begun recruitment. Clinical efficacy and safety conclusions cannot be drawn until trial completion and data publication.
Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Major Depressive Disorder (MDD), Major Depressive Disorder With Psychotic Features; age from 19 Years; to 64 Years. Intervention: Lurasidone + Antidepressant. Compared with: Placebo + Antidepressant — Placebo Comparator. n = 364. Multicenter (specific sites not detailed in registry record)..
This is a Phase 3 randomized, placebo-controlled trial registration evaluating lurasidone as adjunctive therapy for major depressive disorder with inadequate antidepressant response. No results are reported in this registry record; the study has not yet begun recruitment. Clinical efficacy and safety conclusions cannot be drawn until trial completion and data publication.
Efficacy and safety data are not available; conclusions cannot be drawn until trial completion and publication.
The source did not state who this applies to in practice.
This is a Phase 3 trial registration with no results reported; the study is not yet recruiting, so evidence on efficacy and safety cannot be assessed.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07781293). This is a study registration, not published results. Lead sponsor: Bukwang Pharmaceutical. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 364 participants (ESTIMATED). Conditions: Major Depressive Disorder (MDD), Major Depressive Disorder With Psychotic Features. Interventions: DRUG: Lurasidone; DRUG: Placebo; DRUG: Background Antidepressant Therapy. Primary outcome measures: Change From Baseline in Montgomery-Åsberg Depression Rating Scale Total Score at Week 8 , Baseline to Week 8. Brief summary: This Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of lurasidone as adjunctive therapy in adult patients with major depressive disorder (MDD) who show an inadequate response to antidepressant monotherapy. Eligible participants will continue their background antidepressant treatment and be randomized to receive either lurasidone (20, 40, or 60 mg/day) or placebo for 8 weeks. The primary endpoint is the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 8. Secondary endpoints include response and remission rates, changes in Clinical Global Impression-Severity (CGI-S), 17-item Hamilton Depression Rating Scale (HAM-D17), Hamilton Anxiety Rating Scale (HAM-A), and Sheehan Disability Scale (SDS) scores. Safety assessments will include adverse events, laboratory tests, electrocardiograms (ECGs), vital signs, and suicidality monitoring Columbia-Suicide Severity Rating Scale (C-SSRS).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.