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
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)
• Current manic or mixed episode
Rapid cycling bipolar disorder
Substance use disorder
Severe neurological illness or medical emergency