Ignite Creation Date:
2024-05-06 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05324735
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2022-03-25
Brief Title:
Pentoxifylline for Treatment of Resistant Major Depression
Sponsor:
Hawler Medical University
Organization:
Hawler Medical University
Study Overview
Official Title:
Pentoxifylline for Treatment of Resistant Major Depression A Randomized Double Blind Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A growing body of evidence has highlighted the role of inflammation and phosphodiesterases PDE-related pathways in the pathogenesis of neuropsychiatric illnesses such as depressionmood disorders Herein we aimed to evaluate the therapeutic benefits of pentoxifylline PTX in the treatment of therapy-resistant depression TRD in adult patients with bipolar depression
Detailed Description:
Depression which affects an estimated 300 million people worldwide is the main cause of mental health-related illness burden Depression keeps people from attaining their full potential depletes human capital and is linked to suicide and other forms of mortality Despite the fact that depressive disorders have a better prognosis than primary psychotic illnesses like schizophrenia 20-40 of patients treated with antidepressants do not respond to their initial treatment regimens and up to 15 do not respond to multiple antidepressant regimens and modalities such as electroconvulsive shock ECT therapy Since the treatment resistance has been shown to increase the likelihood of full symptomatic recurrence worsen the treatment course and quality of life therefore there is a critical need for innovative treatment techniques for patients who have failed to respond to traditional treatments Inflammation is one factor that has gotten a lot of attention lately as an etiologic mechanism of treatment-resistant depression TRD Increased levels of pro inflammatory markers such as tumor necrosis factor-alpha TNF-α interleukin IL-1 and IL-6 are reported in a considerable percentage of patients with major depressive disorders with or without other comorbidities including bipolar depression and TRD patients Also clinical factors connected to antidepressant response are linked to the reduction of inflammatory cytokines
Moreover cytokine antagonists such as the chimeric anti-TNF-alpha antibody infliximab has shown antidepressant efficacy Hence given the elevated levels of inflammatory activity in TRD patients new treatments with anti-inflammatory effect might be an effective approach to treat these patients Pentoxifylline PTX is a methylated xanthine derivative that has been used to treat peripheral vascular disease for more than two decades PTX has anti-inflammatory and phosphodiesterase PDE inhibitory effects that enables it to inhibit PDEs competitively Subsequently it can increase cAMP levels activate protein kinase A PKA inhibit ILs and TNF-α production and reduce inflammation Therefore PTX-decreased inflammatory activity may give rapid symptomatic alleviation for medically healthy individuals with TRD depression
Moreover cytokine antagonists such as the chimeric anti-TNF-alpha antibody infliximab has shown antidepressant efficacy Hence given the elevated levels of inflammatory activity in TRD patients new treatments with anti-inflammatory effect might be an effective approach to treat these patients Pentoxifylline PTX is a methylated xanthine derivative that has been used to treat peripheral vascular disease for more than two decades PTX has anti-inflammatory and phosphodiesterase PDE inhibitory effects that enables it to inhibit PDEs competitively Subsequently it can increase cAMP levels activate protein kinase A PKA inhibit ILs and TNF-α production and reduce inflammation Therefore PTX-decreased inflammatory activity may give rapid symptomatic alleviation for medically healthy individuals with TRD depression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None