NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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 RecruitingPhase 4

Sponsor: Watim Medical & Dental College

Conditions: Bipolar 1 Depression

Interventions: Lumateperone, Cariprazine

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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