ArticleNeuropsychiatric disease and treatment2026
Efficacy of Adjunctive Lumateperone 42 mg on Anhedonia and Across a Broad Range of Depressive Symptoms in Major Depressive Disorder: Post Hoc Analysis of a Phase 3, Randomized, Placebo-Controlled Trial.
Article in Neuropsychiatric disease and treatment, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04985942 (A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder), which is not on this map. Not yet cited in PubMed.
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.
A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: Lumateperone is a mechanistically novel Food and Drug Administration-approved antipsychotic to treat schizophrenia, depressive episodes associated with bipolar I and II disorder, and major depressive disorder (MDD). This analysis of the Phase 3, randomized, double-blind, placebo-controlled, multicenter Study 501 (NCT04985942) evaluated the broad efficacy of lumateperone across depression symptoms assessed by Montgomery-Åsberg Depression Rating Scale (MADRS) anhedonia factor and single-item scores. Patients and Methods: Eligible adults (18-65 years) met DSM-5 criteria for MDD with inadequate response to 1 or 2 ADTs in the current depressive episode and had MADRS Total score ≥24, Clinical Global Impression-Severity score ≥4, and Quick Inventory of Depressive Symptomatology-Self-Report 16-item score ≥14. Patients were randomized to oral placebo or lumateperone 42 mg adjunctive to ADT for 6 weeks. A post hoc analysis assessed anhedonia symptoms according to MADRS anhedonia factor. MADRS Total score and MADRS anhedonia factor score were analyzed by baseline anhedonia factor score (median value: ≥18). A prospective analysis investigated change in individual MADRS items. Results: Lumateperone+ADT significantly improved anhedonia symptoms versus placebo+ADT at every visit according to MADRS anhedonia factor score (Day 43: least squares mean difference vs adjunctive placebo [LSMD], -2.5; effect size [ES], -0.50; Conclusion: Lumateperone 42mg+ADT significantly improved symptoms of anhedonia and a broad range of depression symptoms compared with placebo+ADT in patients with MDD with inadequate response.
Indexed as
Identifiers
What Socratic holds
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.