Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Depressive Disorder, Major
In brief
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
Key facts
- Study ID
- NCT06860958
- Run by
- Tanta University
- People needed
- 60
- Starts
- 2025-03-01
- Expected to finish
- 2027-08-20
- Last updated by the study team
- 2026-05-04
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Tanta Unuversity — Tanta, Egypt (enrolling)
Full record on ClinicalTrials.gov
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