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 | Not Yet Recruiting Phase 4

• 2 other identifiers: WMDC-RCT-BD-2026-01WM&DC/R&D (IERB) /2026/264
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bipolar 1 Depression

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score

  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)

Study Arms (2)

lumateperone plus mood stabilizer

EXPERIMENTAL

Lumateperone administered as adjunctive therapy in addition to ongoing mood stabilizer treatment for bipolar I depressive episode

Drug: Lumateperone

Cariprazine plus mood stabilizer

ACTIVE COMPARATOR

Cariprazine administered as adjunctive therapy in addition to ongoing mood stabilizer treatment for bipolar I depressive episode.

Drug: Cariprazine

Interventions

Lumateperone DRUG

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

lumateperone plus mood stabilizer

Cariprazine DRUG

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

Cariprazine plus mood stabilizer

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Watim Medical & Dental College: lead

MeSH Terms

Interventions

lumateperone; cariprazine

Central Study Contacts

Wardha Mazhar Malik, MBBS, Mphil

CONTACT

03315108703; wardhajibran@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Pharmacology

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06