Overview

Pentoxifylline Add-on Therapy for Schizophrenia

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mazra Mental Health Center
Collaborator:
Ben-Gurion University of the Negev
Treatments:
Pentoxifylline
Criteria
Inclusion Criteria:

1. Patients meeting the DSM-V criteria for schizophrenia spectrum disorders.

2. Clinical Global Impression (CGI) score ≥ 4 and ≤ 6 at screening.

3. Initiated treatment with a stable dosage of typical and/or atypical antipsychotic
medication for at least four weeks.

Exclusion Criteria:

1. Previous sensitivity to pentoxifylline (PTF).

2. Chronic immune and/or inflammatory diseases (such as rheumatoid arthritis, systemic
lupus erythematosus, chronic inflammatory bowel disease).

3. Consumption for > 3 consecutive days of any immune-modulating or anti-inflammatory
drug in the last month.

4. Current active and persistent substance and/or alcohol abuse.

5. Any severe, unstable medical condition (e.g., cardiovascular disorders, diabetes
mellitus, respiratory diseases, cancer).

6. Obesity (body mass index > 30).

7. Cognitive dysfunction such as retardation.

8. Known or suspected pregnancy or breastfeeding women.

9. Lactose intolerance or sensitivity.