NCT05030623

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

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sadat City University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Antidepressant-like effects of tadalafil to its ability to modulate transduction pathways responsible for neuroplasticity. Treatment with tadalafil 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. Low-dose tadalafil improved both depressive symptoms in patients with erectile dysfunction.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Tadalafil 5Mg Tab	Tadalafil 5Mg Tab plus Fluoxetine 20 mg capsule
DRUG	Placebo	Placebo Tab plus Fluoxetine 20 mg capsule

Timeline

• Start date: 2021-08-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-09-01
• Last updated: 2025-07-14

Locations

1 site across 1 country: Egypt