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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

ConditionBipolar 1 Depression
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorWatim Medical & Dental College

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

• Current manic or mixed episode

Rapid cycling bipolar disorder

Substance use disorder

Severe neurological illness or medical emergency

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lumateperone

    Drug

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

  • Cariprazine

    Drug

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: lumateperone plus mood stabilizerExperimental treatment 1 intervention
Group B: Cariprazine plus mood stabilizerActive comparator 1 intervention

Trial outcomes

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 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)

Time frame
Baseline to Week 6 (Day 45)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Watim Medical & Dental College

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: