Status:
WITHDRAWN
The Phosphodiesterase 5 Inhibitor Sildenafil 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:
NA
Brief Summary
Antidepressant-like effects of sildenafil to its ability to modulate transduction pathways responsible for neuroplasticity. Treatment with sildenafil was shown to be PKG-dependent and lead to increase...
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 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
- Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.
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 :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04344678
Start Date
January 1 2020
End Date
December 31 2024
Last Update
July 14 2025
Active Locations (1)
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1
Faculty of Medicine
Shibīn al Kawm, Egypt