drugset / Trial / NCT05933538
Effectiveness of Cariprazine Monotherapy for Treatment of Major Depressive Disorder
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cariprazine | Small molecule | 4.5 mg | — |