Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
Recruiting
Phase 3
Interventional Study
Depressive Disorder, Major
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Tanta University · Other
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About This Trial
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 treatmen…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patients with age greater than 18 years old.
2. Patients with Ham-D score at least 18 with item 1 depressed mood scored 2 or greater are eligible.
Exclusion Criteria:
1. Patients with bipolar I or bipolar II disorder; eating disorders, personality disorders, and mental reta…
Contacts
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