Bipolar 1 DepressionPhase 4LUCAR-BDNCT07676669
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
A Phase 4 study testing Lumateperone and Cariprazine in people with Bipolar 1 Depression, run by Watim Medical & Dental College.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar 1 Depression
- What is being tested?
- Lumateperone and Cariprazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Bipolar 1 Depression
- Being tested
- Lumateperone, Cariprazine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumateperoneDrug
Lumateperone administered as adjunctive therapy along with ongoing mood stabilizer treatment in patients with Bipolar I depressive episode
CariprazineDrug
Cariprazine administered as adjunctive therapy along with ongoing mood stabilizer treatment in patients with Bipolar I depressive episode.
| Study group | Role | What they receive |
|---|---|---|
| lumateperone plus mood stabilizer | Experimental | Lumateperone administered as adjunctive therapy in addition to ongoing mood stabilizer treatment for bipolar I depressive episode Receives: 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. Receives: Drug: Cariprazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 having minimum to maximum range of 0-60 in patients with Bipolar I depressive episode receiving adjunctive lumateperone or cariprazine with mood stabilizers.• a decrease in score shows improvement. Response to treatment (≥50% decrease in MADRS Total score from baseline to end) and remission (MADRS Total score ≤12)
Measured: Baseline to Week 6 (Day 45)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar 1 DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparative study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Watim Medical & Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wardha Mazhar Malik, Watim Medical & Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676669
- Sponsor's protocol ID
- WMDC-RCT-BD-2026-01
- Other IDs
- WM&DC/R&D (IERB) /2026/264
- Acronym
- LUCAR-BD
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Efficacy And Safety Of Lumateperone And Cariprazine as Adjunctive Treatment in Bipolar I Depression
- ClinicalTrials.gov ID
- NCT07676669
- Acronym / sponsor ID
- LUCAR-BD / WMDC-RCT-BD-2026-01
- Conditions
- Bipolar 1 Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Watim Medical & Dental CollegeUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- comparative study
| Arm | Type | Receives |
|---|---|---|
| lumateperone plus mood stabilizer | Experimental | Drug: LumateperoneLumateperone administered as adjunctive therapy in addition to ongoing mood stabilizer treatment for bipolar I depressive episode |
| Cariprazine plus mood stabilizer | Active comparator | Drug: CariprazineCariprazine administered as adjunctive therapy in addition to ongoing mood stabilizer treatment for bipolar I depressive episode. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- • Current manic or mixed episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumateperoneLumateperone administered as adjunctive therapy along with ongoing mood stabilizer treatment in patients with Bipolar I depressive episode | Drug | lumateperone plus mood stabilizer |
| CariprazineCariprazine administered as adjunctive therapy along with ongoing mood stabilizer treatment in patients with Bipolar I depressive episode. | Drug | Cariprazine plus mood stabilizer |
Primary outcome
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 having minimum to maximum range of 0-60 in patients with Bipolar I depressive episode receiving adjunctive lumateperone or cariprazine with mood stabilizers.• a decrease in score shows improvement. Response to treatment (≥50% decrease in MADRS Total score from baseline to end) and remission (MADRS Total score ≤12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lumateperone and Cariprazine in people with Bipolar 1 Depression, run by Watim Medical & Dental College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wardha Mazhar Malik, MBBS, Mphil (03315108703, wardhajibran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score (time frame: Baseline to Week 6 (Day 45)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.