Pentoxifylline for Treatment of Resistant Major Depression

NCT05324735 | Completed Phase 1 DMC

• 1 other identifier: HMU PE-EC 24112021/391
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Resistant Major Depression

Keywords

Bipolar Depression; Pentoxifylline; Resistant Major Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale-17 (HAM-D-17) Scores

  The HAM-D-17 is a 17-item scale that asks participants to rate the severity of their depression symptoms. Scoring is based on the 17-item scale. The total score ranges from 0 to 52, with higher numbers demonstrating more severe symptoms. Normal scores range from 0 to 7, mild depression ranges from 8 to 16, moderate depression ranges from 17 to 23, and scores of 24 and greater indicate severe depression. Remission is defined as HAM-D-17 total score ≤ 7 (primary outcome).

  12 weeks

Secondary Outcomes (5)

• Response Rate

  12 weeks

• Remission Rate

  12 weeks

• Serum level of CRP

  12 weeks

• Serum level of TNF-α

  12 weeks

• Serum level of IL-6

  12 weeks

Study Arms (2)

Pentoxifylline

EXPERIMENTAL

Pentoxifylline (tablet): 400 mg twice a day for 12 weeks

Drug: Pentoxifylline

Control group

PLACEBO COMPARATOR

Placebo (tablet): twice a day for 12 weeks

Drug: Placebo

Interventions

Pentoxifylline DRUG

All participants will receive pentoxifylline 400 mg (orally ingested) twice a day for 12 weeks.

Also known as: Trental

Pentoxifylline

Placebo DRUG

All participants will receive placebo (orally ingested) twice a day for 12 weeks.

Also known as: Sugar Pills

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler Psychiatric Hospital and Private Clinic

Erbil, 44001, Iraq

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Talar A Merzamohammad, Pharm. D

  Hawler Medical University, College of Pharmacy, Department of Pharmacology and Toxicology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 12, 2022
• Study Start: December 15, 2021
• Primary Completion: May 4, 2022
• Study Completion: June 4, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)