Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT06860958

Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Led by Tanta University · Updated on 2026-05-04

60

Participants Needed

1

Research Sites

128 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged over 18 years old
  • Patients with a Hamilton Depression Rating Scale (Ham-D) score of at least 18, with a depressed mood item score of 2 or greater
Not Eligible

You will not qualify if you...

  • Patients with bipolar I or bipolar II disorder; eating disorders; personality disorders; mental retardation; current anxiety disorders (except specific phobia)
  • Patients with mental disorder due to general medical condition
  • Patients with substance dependence or abuse in the previous three months
  • Patients with concurrent medical illness or history of seizures that contraindicate study medication
  • Patients receiving Electroconvulsive therapy (ECT)
  • Pregnant women or women not using medically accepted birth control
  • Patients scoring greater than 2 on the suicide item of the Ham-D or judged to have significant suicidal ideation
  • Patients required to be free of all psychotropic medications except escitalopram and anti-inflammatory drugs for at least four weeks before study entry

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tanta Unuversity

Tanta, Egypt, 31527

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients | DecenTrialz