RecruitingPhase 3NCT06860958

Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients


Sponsor

Tanta University

Enrollment

60 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called Roflumilast (typically used for lung disease) to standard antidepressant treatment can improve outcomes for people with major depressive disorder. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with major depressive disorder and have a moderate-to-severe depression score on a clinical rating scale **You may NOT be eligible if...** - You have bipolar disorder, an eating disorder, a personality disorder, or a current anxiety disorder diagnosis (other than specific phobia) - You have had substance dependence or abuse in the last 3 months - You are pregnant or not using reliable contraception - You are currently receiving electroconvulsive therapy (ECT) - You have a condition or medical history that would make the study medication unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFluoxetine

Fluoxetine is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs)

DRUGRoflumilast

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

DRUGPlacebo

Placebo


Locations(1)

Tanta Unuversity

Tanta, Egypt

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NCT06860958


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