Evidence map›Paper›PMID 41017591›Full record

Trial reportCNS spectrums2025

Efficacy of Lumateperone in depression associated with bipolar II disorder: a pooled analysis of late-phase clinical trials.

Suresh Durgam, Hassan Lakkis, Susan G Kozauer, Changzheng Chen, Roger S McIntyre

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in CNS spectrums, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Suresh DurgamIntra-Cellular Therapies, a Johnson & Johnson Company, Bedminster, NJ, USA.ORCID 0000-0001-6629-0619
Hassan LakkisIntra-Cellular Therapies, a Johnson & Johnson Company, Bedminster, NJ, USA.
Susan G KozauerIntra-Cellular Therapies, a Johnson & Johnson Company, Bedminster, NJ, USA.
Changzheng ChenIntra-Cellular Therapies, a Johnson & Johnson Company, Bedminster, NJ, USA.
Roger S McIntyreDepartment of Psychiatry, University of Toronto, Toronto, ON, Canada.ORCID 0000-0003-4733-2523

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTreatment options are limited for depressive episodes in patients with bipolar II disorder. This post hoc analysis evaluated the efficacy of lumateperone in three pooled short-term, Phase 3 studies in patients with a major depressive episode (MDE) associated with bipolar II disorder.

methodsThis post hoc analysis pooled data from patients (18-75 years) with

resultsLumateperone significantly improved MADRS Total score at Day 43 in the bipolar II population (placebo,

conclusionsLumateperone 42 mg monotherapy or adjunctive therapy significantly improved symptoms of depression and disease severity in patients with bipolar II disorder across Phase 3 studies. Lumateperone was generally well tolerated. These results support lumateperone 42 mg to treat MDEs associated with bipolar II disorder.

Indexed as

Antidepressive AgentsApigeninBipolar DisorderMajor Depressive DisorderAdolescentAdultAgedAntimanic AgentsDouble-Blind MethodFemaleHeterocyclic Compounds, 4 or More RingsHumansMaleMiddle AgedTreatment OutcomeValproic AcidAntidepressive AgentsAntimanic AgentsApigeninHeterocyclic Compounds, 4 or More RingslumateperoneValproic AcidAdjunctive therapyAntipsychotic agentsbipolar depressionbipolar II disorderlumateperone

Identifiers

PMID41017591
PMCPMC13064759

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Registered trials

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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.