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RECRUITING
NCT06860958
PHASE3

Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Sponsor: Tanta University

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-03-01

Completion Date

2026-08-20

Last Updated

2025-03-18

Healthy Volunteers

No

Interventions

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

Locations (1)

Tanta Unuversity

Tanta, Egypt