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NCT06860958
Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
Phase 3 trial testing Fluoxetine in Depressive Disorder, Major in 60 participants. Currently enrolling.
20 March 2026
Quick facts
| Lead sponsor | Tanta University |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 March 2025 |
| Primary completion | 20 March 2026 |
| Estimated completion | 20 August 2026 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Fluoxetine (fluoxetine) — full drug profile →
- Roflumilast (ROFLUMILAST) — full drug profile →
- Placebo
Conditions studied
- Depressive Disorder, Major — all drugs for Depressive Disorder, Major →
Sponsor
Tanta University
Who can join
Adults 18 to 65, any sex, with Depressive Disorder, Major. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06860958
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Depressive Disorder, Major
Currently open trials in the same condition.
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- NCT07059234 — The Motor Activity - Subjective Energy (MASE) Project · NA · recruiting
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- NCT05553353 — Dosing rTMS for Depression Post-SCI · NA · recruiting
Other Tanta University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06860958 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tanta University
- Last refreshed: 18 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06860958.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing