The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

Sponsor
Sadat City University
Study ID
NCT04751071
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast 500Mcg Tab — DRUG
    Roflumilast 500µg tablet once daily for 6 weeks plus the standard therapy
  • Placebo — DRUG
    Placebo tablet once daily for 6 weeks plus the standard therapy

Study Details

n pre-clinical studies and early-stage clinical trials, PDE4 inhibitors such as rolipram have been shown to enhance memory. They also improve depressive-like behaviors induced by chronic unpredictable mild stress, lipopolysaccharide, or ethanol abstinence . Consequently, it is reasonable to believe that PDE4 is a potential target for treatment of the comorbidity of depression and AD.The aim of the current study is to evaluate the potential adjunct antidepressant effect of the Phosphodiesterase-4 Inhibitor Roflumilast in adult patients with MDD.

Key Dates

Start date
Feb 1, 2021
Status verified
Jul 2025
Primary completion
Oct 1, 2024
Completion
Dec 1, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Roflumilast
    Roflumilast 500 µg tablet plus standard therapy
  • Placebo Comparator: Placebo
    placebo tablet plus standard therapy

Primary Outcome Measure

Effect on Hamilton Depression rating scale score (HAM-D score) [ Time Frame: 6 weeks ]

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