NCT04344678

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

The Phosphodiesterase 5 Inhibitor Sildenafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients: Randomized, Double-Blind, Placebo-Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sadat City University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Sildenafil Citrate	Esitalopram 20 mg tablet plus Sildenafil Citrate 50 mg tablet once daily
DRUG	Placebo oral tablet	Esitalopram 20 mg tablet plus placebo tablet once daily

Timeline

• Start date: 2020-01-01
• Primary completion: 2024-10-31
• Completion: 2024-12-31
• First posted: 2020-04-14
• Last updated: 2025-07-14

Locations

1 site across 1 country: Egypt