NCT06860958RecruitingPhase 3
Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 1 Mar 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 20 Mar 2027
- Lead sponsor
- Tanta University
- Diseases
- Depression
- NCT number
- NCT06860958
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 60
- From 1 Mar 2025 to the primary completion date, 20 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta Unuversity Coordinator of this site? Confirm its status | Tanta | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.