Overview

Pentoxifylline for Treatment of Resistant Major Depression

Status:
Completed
Trial end date:
2022-04-04
Target enrollment:
0
Participant gender:
All
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. 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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hawler Medical University
Treatments:
Pentoxifylline
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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)