The Phosphodiesterase 5 Inhibitor Sildenafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients

NCT ID: NCT04344678

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-12-31

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 increased expression of cGMP, pCREB, BDNF and VGF in the hippocampus and prefrontal cortex (PFC), brain areas relevant to mood disorders pathophysiology. Sildenafil produces antidepressant-like effects by inhibiting oxidative stress in the hippocampus and by decreasing the levels of IL-1β in the hippocampus and striatum.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

Escitalopram 20 mg tablet plus one placebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

Esitalopram 20 mg tablet plus placebo tablet once daily

Sildenafil group

Escitalopram 20 mg tablet plus one Sildenafil 50 mg tablet

Group Type: EXPERIMENTAL

Sildenafil Citrate

Intervention Type: DRUG

Esitalopram 20 mg tablet plus Sildenafil Citrate 50 mg tablet once daily

Interventions

Sildenafil Citrate

Esitalopram 20 mg tablet plus Sildenafil Citrate 50 mg tablet once daily

Intervention Type: DRUG

Placebo oral tablet

Esitalopram 20 mg tablet plus placebo tablet once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sadat City University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Samy Abdallah

Lecturer of Clinical Pharmacy, PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine

Shibīn al Kawm, , Egypt

Countries

Egypt

Other Identifiers

0044/2020

Identifier Type: -

Identifier Source: org_study_id