NCT05271084

Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder

Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Hawler Medical University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to test if combining the antidepressant Citalopram with Pentoxifylline (PTX), a medicine with anti-inflammatory and phosphodiesterase inhibitory properties, enhanced antidepressant efficacy in adult patients with major depressive disorder (MDD) when compared to Citalopram alone.

Detailed description

According to mounting evidence, inflammation and phosphodiesterase (PDE) pathways may play a role in the pathogenesis of psychiatric diseases such as MDD. PTX is a phosphodiesterase inhibitor and has anti-inflammatory and antioxidant effects. Therefore, it has been hypothesized that MDD patients taking combined administration of the Citalopram, a Selective Serotonin Reuptake Inhibitor (SSRI), and PTX would show a higher improvement in depression symptoms. The relationship between the Hamilton Depression Rating Scale-17 items (Ham-D-17) score and various biological markers and their potential role in the therapeutic outcome of MDD will be assessed.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Citalopram (tablet) 20 mg + Pentoxifylline (tablet) 400Mg	Selective serotonin reuptake inhibitor (SSRI) + phosphodiesterase inhibitor with anti-inflammatory properties
DRUG	Citalopram (tablet) 20 mg + Placebo (tablet)	Selective serotonin reuptake inhibitor (SSRI) + placebo

Timeline

• Start date: 2021-11-10
• Primary completion: 2022-02-25
• Completion: 2022-06-08
• First posted: 2022-03-08
• Last updated: 2022-09-07

Locations

1 site across 1 country: Iraq