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Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 16, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
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Registry record from ClinicalTrials.gov (NCT07623135). This is a study registration, not published results. Lead sponsor: Eric Lenze. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Treatment Resistant Depression (TRD), Late Life Depression (LLD), Depression / Major Depressive Disorder. Interventions: DRUG: Lumateperone; DRUG: Placebo. Primary outcome measures: Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score , From baseline to the end of treatment at week 10.. Brief summary: The purpose of this research study is to examine how well a medication called lumateperone (Caplyta) works to relieve depression in older adults with treatment-resistant depression. Lumateperone (Caplyta) is approved by the U.S. Food and Drug Administration to treat Major Depressive Disorder in adults who are also taking another antidepressant medication. This study will compare lumateperone (Caplyta) to placebo (a sugar pill without medication).