Status:
WITHDRAWN
The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
Lead Sponsor:
Sadat City University
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
Phosphodiesterase-4 (PDE4), an important member of the PDE superfamily, is a key regulator of intracellular cyclic AMP (cAMP) level. As the second messenger, cAMP activates protein kinase A, which pho...
Eligibility Criteria
Inclusion
- • Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 20 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
Exclusion
- Patients with bipolar I or bipolar II disorder
- Patients with personality disorders
- Patients with eating disorders
- Patients with substance dependence or abuse
- Patients with concurrent active medical condition
- Patients with history of seizures
- Patients with history of receiving Electroconvulsive therapy (ECT)
- Patients with inflammatory disorders
- Patients with allergy or contraindications to the used medications
- Patients with finally pregnant or lactating females
- Cardiovascular disorders
- Severe renal impairment: creatinine clearance of ≤ 25 ml/min
- Moderate or severe hepatic impairment
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04751071
Start Date
February 1 2021
End Date
December 1 2025
Last Update
July 14 2025
Active Locations (1)
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1
Faculty of Pharmacy
Shibeen Elkom, Menoufia, Egypt, 13829