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Bipolar Disorder Depression / Lurasidone (Latuda) · Phase 4 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 4 trial registration for a planned mechanistic study combining clinical depression assessment with brain mitochondrial imaging in bipolar disorder patients treated with lurasidone. No results are yet posted in this registry record; the study is in pre-recruitment status and therefore reports no efficacy or safety data.
Phase 4, Interventional, Single Group, Open label, Treatment purpose. Bipolar Disorder Depression; age from 18 Years; to 60 Years; accepts healthy volunteers. Intervention: Bipolar Disorder. Compared with: Healthy Volunteer — No Intervention. n = 60. 1 site: United States.
This is a Phase 4 trial registration for a planned mechanistic study combining clinical depression assessment with brain mitochondrial imaging in bipolar disorder patients treated with lurasidone. No results are yet posted in this registry record; the study is in pre-recruitment status and therefore reports no efficacy or safety data.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This study is preparatory and has no clinical impact pending completion and results reporting. Clinicians should not alter bipolar depression management based on this registry entry alone.
This is a registered Phase 4 interventional study not yet recruiting, with no results posted; it describes a planned mechanistic investigation of brain cytochrome c oxidase in bipolar depression using near-infrared spectroscopy and lurasidone treatment.
As stated by the source record.
Quoted from the source exactly as published.
This study is preparatory and has no clinical impact pending completion and results reporting. Clinicians should not alter bipolar depression management based on this registry entry alone.
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 (NCT07806227). This is a study registration, not published results. Lead sponsor: Martin Lan. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Bipolar Disorder Depression. Interventions: DRUG: Lurasidone (Latuda). Primary outcome measures: Bipolar Depression Rating Scale , 6 weeks. Brief summary: People with a diagnosis of bipolar disorder who are depressed will have a light-based imaging of the brain (Near Infrared Spectroscopy) before and after they have treatment for their depression with a standard, approved medication named lurasidone. They will also answer questions about their history, and give blood samples. The goal is to understand the role of mitochondrial activity in bipolar disorder. Healthy volunteers who have never had a psychiatric disorder will have the same procedures, but they will not receive the medication.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.