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Life sciences · Phase 4 Trial
ClinicalTrials.gov · October 7, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 4 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.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07676669). This is a study registration, not published results. Lead sponsor: Watim Medical & Dental College. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 140 participants (ESTIMATED). Conditions: Bipolar 1 Depression. Interventions: DRUG: Lumateperone; DRUG: Cariprazine. Primary outcome measures: Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score , Baseline to Week 6 (Day 45). Brief summary: This study aims to compare the efficacy and safety of lumateperone and cariprazine as adjuncts in patients with depression associated with bipolar I using standardized efficacy assessment tools such as the Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression bipolar severity scale (CGI-BP-S) and recording treatment emergent adverse effect. Participants will undergo baseline assessment on day 0 using these scales. Follow-up assessments using MADRS and CGI scales will be conducted at Day 15, Day 30 and Day 45. Safety analysis will be performed for all participants who receive at least one dose of study medication. Vitals and treatment-emergent adverse events (TEAEs) will be recorded at every visit