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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sadat City University
• Treatments: Antidepressive Agents; Citric Acid; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate

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