Tests roflumilast added to antidepressants for major depression
Tests roflumilast with fluoxetine in adults with major depressive disorder.
Key facts
- Who runs it
- Tanta University
- Where
- Tanta, EgyptSee the site
- Trial code
- Registry title
- Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 60 people, planned
- Started
- 1 Mar 2025
- Expected to end
- 20 Aug 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Fluoxetine
- Roflumilast
- Placebo
- Record updated
- 4 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with major depressive disorder and a moderate to high depression score. It tests roflumilast added to an antidepressant.
- Age
- Over 18 years, up to 65 years.
- Sex
- All sexes can join.
- Disease stage
- Major depressive disorder with a Ham-D score of at least 18, and a score of 2 or greater on the depressed mood item.
- Earlier treatment
- Must be free of all psychotropic medicines for at least four weeks before the start, except escitalopram and anti-inflammatory medicines.
Main reasons for not taking part
- Bipolar I or bipolar II disorder
- Eating disorder, personality disorder or mental retardation
- Substance dependence or abuse in the previous three months
- Pregnant, or not using accepted birth control
- Score above 2 on the suicide item of the Ham-D, or significant suicidal thoughts
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- 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
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Egypt
- Tanta UnuversityTanta, EgyptContact: Mostafa M I Bahaa, PhDTaking people
About the trial
What the trial wants to find out
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
The 2 groups in the trial
- Control groupExisting treatment, for comparison
30 patients will receive fluoxetine 20 mg/day plus placebo
Treatment: Fluoxetine and Placebo
- Comparative groupExisting treatment, for comparison
35 patients will receive fluoxetine 20 mg/day plus roflumilast
Treatment: Fluoxetine and Roflumilast
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
- Plain-language title
- Tests roflumilast added to antidepressants for major depressionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06860958, who can take part
- Record updated
- 4 May 2026