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NCT Number: NCT06860958

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

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tanta Unuversity

Tanta, 31527, Egypt

Location status: Recruiting

Location contact

Mostafa M Bahaa, PhD

SUB_INVESTIGATOR

Mostafa M I Bahaa, PhD

CONTACT

[email protected]

0201025538337

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with age greater than 18 years old.
  • Patients with Ham-D score at least 18 with item 1 depressed mood scored 2 or greater are eligible.

Exclusion criteria

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

Treatment and study plan

Fluoxetine

Drug

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

Roflumilast

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. The principal measure of the outcome will be the 17-item Ham-D

    Time frame: 2 months

    • Patients will be assessed by a psychiatrist at baseline, 4, and 8 weeks after starting the medication. The principal measure of the outcome will be the 17-item Ham-D.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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