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Treatment of Bipolar Depression With Pentoxifylline — PTX-BD  

Bipolar Depression Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04417049
Study type Interventional
Source University Health Network, Toronto
Contact
Status Completed
Phase Early Phase 1
Start date July 12, 2021
Completion date November 29, 2021
View Details
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