Status:
COMPLETED
Pentoxifylline for Treatment of Resistant Major Depression
Lead Sponsor:
Hawler Medical University
Conditions:
Resistant Major Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 depression/mood disorders. H...
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 hu...
Eligibility Criteria
Inclusion
- Provide written, voluntary informed consent prior to study enrollment.
- Male or female between the ages of 18 to 65.
- Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV) criteria for bipolar I or II, currently experiencing a major depressive episode. A Mini-International Neuropsychiatric Interview (MINI) conducted by physician was used to confirm the diagnosis.
- Meets the criteria for treatment resistant depression (TRD) defined by failure to respond to of at least two treatment trials (antidepressant regimen or electroconvulsive therapy) during the current depressive episode.
- Prior to taking part in the trial, all patients were requested to be antidepressant free for 4 weeks or to be on a fixed psychotropic therapeutic regimen for at least 4 weeks.
Exclusion
- Current psychotic symptoms or perceptual problems.
- The presence of a contraindication to PTX, such as a drug allergy or xanthine derivative allergy.
- Patients with substance dependence or abuse.
- Patients with concurrent active medical condition (congestive heart failure, abnormal electrocardiogram, malignancy, schizophrenia, neurological disease).
- Patients with inflammatory disorders and/or auto-immune conditions (rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, lupus)
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05324735
Start Date
December 15 2021
End Date
June 4 2022
Last Update
September 7 2022
Active Locations (1)
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1
Hawler Psychiatric Hospital and Private Clinic
Erbil, Iraq, 44001