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This Study Aims to Compare the Efficacy and Safety of Lumateperone and Cariprazine in Patients With Bipolar I Depression Using Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression Bipolar Severity Scale (CGI-BP-S) and Recording Treatment Emergent Adverse Effects.

NCT07676669 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-06-30

No results posted yet for this study

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

Conditions

  • Bipolar 1 Depression

Interventions

DRUG

Cariprazine

Cariprazine administered as adjunctive therapy along with ongoing mood stabilizer treatment in patients with Bipolar I depressive episode.

DRUG

Lumateperone

Lumateperone administered as adjunctive therapy along with ongoing mood stabilizer treatment in patients with Bipolar I depressive episode

Sponsors & Collaborators

  • Watim Medical & Dental College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2027-03-31
Completion
2027-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07676669 on ClinicalTrials.gov