Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
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 studied
Depressive Disorder, Major
About this study
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
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
Primary outcomes
- The principal measure of the outcome will be the 17-item Ham-D (2 months)
Eligibility information
Study locations
- Tanta Unuversity, Tanta, 31527 Egypt
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.