NCT04417049

Treatment of Bipolar Depression With Pentoxifylline

Pentoxifylline for Bipolar Depression: A Proof-of-Concept Feasibility Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Growing theoretical and clinical evidence has suggested that pentoxifylline may have an effect in improving depressive symptoms. Herein, we aim to evaluate the effect of pentoxifylline in patients with bipolar depression over an 8-week trial.

Detailed description

Growing evidence has demonstrated that inflammation and alterations in cerebral blood flow (CBF) contribute to the pathophysiology of bipolar depression (BD). Pentoxifylline is a phosphodiesterase inhibitor that improves CBF and has potent anti-inflammatory and antioxidant effects. We therefore hypothesize that pentoxifylline may have antidepressant effects in BD. We will conduct an 8-week, open-label, single-armed, feasibility study assessing clinical and neurobiological effects of adjunctive pentoxifylline in the acute treatment of BD. Feasibility will be determined by evaluating recruitment/retention rates, target engagement (e.g., changes in biomarkers with pentoxifylline treatment) and preliminary efficacy testing with 6 participants. Evaluating pentoxifylline's effects may further our understanding of BD pathophysiology and help identify novel treatment targets.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	Pentoxifylline 400 MG	All patients will be provided with pentoxifylline 400 mg to be orally ingested twice daily for 8 weeks.

Timeline

• Start date: 2021-07-12
• Primary completion: 2021-11-03
• Completion: 2021-11-29
• First posted: 2020-06-04
• Last updated: 2022-04-15

Locations

1 site across 1 country: Canada