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Withdrawn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

First listed
Feb 11, 2021
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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