Bipolar Depression Depressed Phase / Obesity & Overweight / Lumateperone 42 mg · Phase 4 Trial

The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 4 trial registration examining lumateperone 42 mg in adults with bipolar depression and obesity, with planned assessment of mood (MADRS), inflammatory markers, and brain biological age at 6 weeks. No results are posted in this registry record; the study is currently recruiting.

What was studied

Phase 4, Interventional, Single Group, Open label, Treatment purpose. Bipolar Depression Depressed Phase, Obesity & Overweight; age from 18 Years; to 65 Years. Intervention: Lumateperone treatment. n = 25. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This early-phase study may generate preliminary data on lumateperone's effects on mood and inflammation in bipolar depression, but results are not yet available and sample size is small; clinicians should await completion and publication before considering implications for practice.

Plain-language summary

This is a Phase 4 trial registration with no posted results; the study is actively recruiting and designed to explore lumateperone's effects on mood, inflammation, and brain aging in bipolar depression.

Study design

As stated by the source record.

MethodsPrimary outcome measures: MADRS (assessed at 6 week); Inflammatory Markers (assessed at 6 weeks)

DesignPhase 4, Interventional, Single Group, Open label, Treatment purpose

PopulationBipolar Depression Depressed Phase, Obesity & Overweight; age from 18 Years; to 65 Years

Sample size25

InterventionLumateperone treatment

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment25

Study phasePHASE 4

Primary outcome 1MADRS at 6 weeks

Primary outcome 2Inflammatory Markers at 6 weeks

Follow-up durationapproximately 6 weeks

Clinical bottom line

Caveats

This is a registry record only; no results, effect sizes, or clinical outcomes have been reported.
Small estimated sample size (n=25) limits statistical power for definitive conclusions.
Randomization, blinding, control arm, and masking status not specified in registry.
Study is currently recruiting; completion and data analysis status unknown.

Evidence assessment

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.

Study design

moderate

Phase 4 interventional design specified; randomization and blinding status not stated.

Directness

moderate

Directly addresses bipolar depression; outcomes include clinical (MADRS) and biological (inflammatory markers, brain MRI) measures.

Consistency

insufficient

No results posted; consistency with other evidence cannot be assessed from registry.

Risk of bias

insufficient

Blinding, allocation concealment, and trial conduct details not disclosed in registry record.

Sample adequacy

limited

Estimated enrollment 25 participants; small and underpowered for Phase 4 outcomes.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07699445). This is a study registration, not published results. Lead sponsor: Massachusetts General Hospital. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 25 participants (ESTIMATED). Conditions: Bipolar Depression Depressed Phase, Obesity & Overweight. Interventions: DRUG: Lumateperone 42 mg. Primary outcome measures: MADRS , 6 week; Inflammatory Markers , 6 weeks. Brief summary: This research study examines how a medication called lumateperone may affect mood symptoms, and inflammation in adults with bipolar disorder over approximately 6 weeks. An MRI scan to calculate biological age of the brain will also be obtained at the start of the study.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07699445Bipolar Depression Depressed PhaseObesity & OverweightMassachusetts General HospitalLumateperone 42 mg