Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Tanta Unuversity
RECRUITING
Tanta
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2026-08-20
Participants
Target number of participants: 60
Treatments
Active_comparator: Control group
30 patients will receive fluoxetine 20 mg/day plus placebo
Active_comparator: Comparative group
35 patients will receive fluoxetine 20 mg/day plus roflumilast
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov