NCT06860958

Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Fluoxetine	Fluoxetine is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs)
DRUG	Roflumilast	Roflumilast is the first drug targeting PDE4 that was marketed for treatment of chronic obstructive pulmonary disease (COPD) with relatively weak potency inducing nausea and vomiting
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-03-20
• Completion: 2026-08-20
• First posted: 2025-03-06
• Last updated: 2025-03-18

Locations

1 site across 1 country: Egypt