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. (LUCAR-BD)

June 23, 2026 updated by: Wardha Mazhar Malik, Watim Medical & Dental College

Comparison Of Efficacy And Safety Of Lumateperone And Cariprazine as Adjunctive Treatment in Bipolar I Depression

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Bipolar I disorder is a chronic and recurrent psychiatric illness characterized by episodes of mania and depression that significantly impair functioning and quality of life. Bipolar depression is associated with substantial morbidity, increased risk of suicide, and reduced psychosocial functioning. Although mood stabilizers remain the cornerstone of treatment, many patients experience inadequate response to mood stabilizer monotherapy, necessitating the use of adjunctive pharmacological agents.

Cariprazine and lumateperone are newer antipsychotic agents that have demonstrated efficacy in the treatment of bipolar depression. Cariprazine is a dopamine D3/D2 receptor partial agonist with preferential affinity for D3 receptors, whereas lumateperone exhibits a unique mechanism involving modulation of dopaminergic, serotonergic, and glutamatergic neurotransmission. Despite evidence supporting the efficacy of both agents, direct comparative data regarding their effectiveness and safety as adjunctive therapy in Bipolar I depression remain limited.

This randomized controlled trial aims to compare the efficacy and safety of lumateperone and cariprazine as adjunctive therapy to ongoing mood stabilizer treatment in adults diagnosed with Bipolar I Disorder experiencing a current depressive episode. Eligible participants will be randomly assigned to receive either lumateperone or cariprazine in addition to their prescribed mood stabilizer for an 6-week treatment period.

The primary efficacy outcome will be the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to Week 6. Secondary efficacy outcomes will include changes in Clinical Global Impression for Bipolar Disorder-Severity (CGI-BP-S) depression scores and assessment of treatment response and remission rates. Treatment response will be defined as a clinically significant reduction in depressive symptoms as measured by MADRS, while remission will be determined using established MADRS threshold criteria.

Safety and tolerability will be evaluated throughout the study through regular monitoring of vital signs, physical examinations, and the occurrence of treatment-emergent adverse events (TEAEs). All adverse events will be documented and assessed for severity and relationship to study medication.

The findings of this study are expected to provide comparative evidence regarding the effectiveness and safety of lumateperone and cariprazine as adjunctive treatment options for Bipolar I depression and may assist clinicians in making evidence-based treatment decisions for patients who demonstrate an inadequate response to mood stabilizer therapy alone.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18-60 years
  • Diagnosed with bipolar I depression according to DSM-5 criteria
  • On stable dose of mood stabilizer (lithium or valproate) for at least 2 weeks
  • Moderate to severe depressive symptoms (baseline MADRS score ≥20)
  • Willing to provide informed consent

Exclusion Criteria:

  • • Current manic or mixed episode

    • Rapid cycling bipolar disorder
    • Substance use disorder
    • Severe neurological illness or medical emergency
    • Pregnancy or lactation
    • Treatment-resistant depression requiring ECT
    • Active suicidal risk requiring emergency intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lumateperone plus mood stabilizer
Lumateperone administered as adjunctive therapy in addition to ongoing mood stabilizer treatment for bipolar I depressive episode
Drug: Lumateperone
Lumateperone administered as adjunctive therapy along with ongoing mood stabilizer treatment in patients with Bipolar I depressive episode
Active Comparator: Cariprazine plus mood stabilizer
Cariprazine administered as adjunctive therapy in addition to ongoing mood stabilizer treatment for bipolar I depressive episode.
Drug: Cariprazine
Cariprazine administered as adjunctive therapy along with ongoing mood stabilizer treatment in patients with Bipolar I depressive episode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score
Time Frame: Baseline to Week 6 (Day 45)
Change in depressive symptom severity from baseline to Week 8, measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in patients with Bipolar I depressive episode receiving adjunctive lumateperone or cariprazine with mood stabilizers.
Baseline to Week 6 (Day 45)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watim Medical & Dental College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMDC-RCT-BD-2026-01
  • WM&DC/R&D (IERB) /2026/264 (Other Identifier: Institutional Ethical Review Board, Watim Medical and Dental College)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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