drugset / Trial / NCT06860958

Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

NCT06860958

Phase 3 Recruiting 60 enrolled Tanta University
RandomizedParallel-groupDouble-blindTreatment

Summary

Major depressive disorder (MDD) is one of the most common psychiatric disorders with serious socioeconomic consequences on daily life and health care costs. Despite the advent of newer antidepressants that target monoamine pathways, nearly 50% of patients have no response to first-line antidepressant therapy. Thus, a combination of medications with different strategies at the beginning of treatment could provide further therapeutic benefits to MDD patients

Timeline

Start
2025-03-01
Primary completion
2027-03-20
Completion
2027-08-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Roflumilast Small molecule
Comparator Fluoxetine Small molecule 20 mg