drugset / Trial / NCT05933538

Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder

NCT05933538

Phase 4 Not yet recruiting 110 enrolled Sultan Qaboos University
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial protocol aims to evaluate the effectiveness and safety of cariprazine monotherapy compared to treatment as usual for major depressive disorder (MDD) in a pragmatic open-label randomized controlled trial (RCT) conducted at Sultan Qaboos University Hospital Department of Behavioral Medicine. The protocol adheres to the guidelines outlined in Good Clinical Practice (GCP) and will be submitted to the Institutional Review Board (IRB) for approval. The trial will assess the efficacy of cariprazine in improving depressive symptoms and overall functioning, as well as its safety profile in patients with MDD.

Timeline

Start
2024-08
Primary completion
2030-08
Completion
2030-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cariprazine Small molecule 4.5 mg