Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Sponsor
Tanta University
Study ID
NCT06860958
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Fluoxetine — DRUG
    Fluoxetine is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs)
  • Roflumilast — DRUG
    Roflumilast is the first drug targeting PDE4 that was marketed for treatment of chronic obstructive pulmonary disease (COPD) with relatively weak potency inducing nausea and vomiting
  • Placebo — DRUG
    Placebo

Study Details

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 Dates

Start date
Mar 1, 2025
Status verified
May 2026
Primary completion
Mar 20, 2027
Completion
Aug 20, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

The principal measure of the outcome will be the 17-item Ham-D [ Time Frame: 2 months ]

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