Pentoxifylline Add-on Therapy for Schizophrenia

NCT05073640 | Unknown Phase 1 DMC

• 1 other identifier: 03-019-MZR
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The etiology and pathogenesis of schizophrenia remain unclear. The immune dysfunction hypothesis for schizophrenia has attracted increasing attention from researchers, and substantial evidence suggested that the levels of TNF-α and other cytokines are markedly elevated in patients with schizophrenia. The investigators aim to evaluate the adjuvant therapeutic effect of Pentoxifylline, a TNF-α inhibitor that crosses the blood-brain barrier, in a randomized, double-blind, 6-week trial. Individuals with schizophrenia will receive either Pentoxifylline or a matching placebo as an add-on treatment to antipsychotic agents. Subjects' positive and negative symptoms and plasma concentration of neuroinflammatory markers will be monitored at baseline and every two weeks until the end of the trial.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Positive and negative symptoms

  Improvement in positive and negative symptoms (Changes in PANSS rates)

  Subjects will be monitored at baseline and every two weeks for six weeks

Secondary Outcomes (1)

• Depressive symptoms

  Subjects will be monitored at baseline and every two weeks for six weeks

Study Arms (2)

Pentoxifylline

ACTIVE COMPARATOR

Pentoxifylline (Oxopurin 400 mg)

Drug: Oxopurin

Placebo

PLACEBO COMPARATOR

Placebo (105 mg Lactose and 510 mg Dextrose)

Drug: Oxopurin

Interventions

Oxopurin DRUG

Subjects will receive two capsules per day.

Also known as: Pentoxifylline

Pentoxifylline; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients meeting the DSM-V criteria for schizophrenia spectrum disorders.
• Clinical Global Impression (CGI) score ≥ 4 and ≤ 6 at screening.
• Initiated treatment with a stable dosage of typical and/or atypical antipsychotic medication for at least four weeks.

You may not qualify if:

• Previous sensitivity to pentoxifylline (PTF).
• Chronic immune and/or inflammatory diseases (such as rheumatoid arthritis, systemic lupus erythematosus, chronic inflammatory bowel disease).
• Consumption for \> 3 consecutive days of any immune-modulating or anti-inflammatory drug in the last month.
• Current active and persistent substance and/or alcohol abuse.
• Any severe, unstable medical condition (e.g., cardiovascular disorders, diabetes mellitus, respiratory diseases, cancer).
• Obesity (body mass index \> 30).
• Cognitive dysfunction such as retardation.
• Known or suspected pregnancy or breastfeeding women.
• Lactose intolerance or sensitivity.

Sponsors & Collaborators

• Mazra Mental Health Center: lead
• Ben-Gurion University of the Negev: collaborator

Study Sites (1)

Mazor MHC

Acre, 25201, Israel

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Alon Shamir, Ph.D.

CONTACT

+97249954708; alons@mazor.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 11, 2021
• Study Start: April 20, 2019
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 11, 2021

Record last verified: 2021-09

Locations

IL (1)