Pentoxifylline Add-on Therapy for Schizophrenia

NCT ID: NCT05073640

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-20
• Study Completion Date: 2022-12-31

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.

Detailed Description

Ninety schizophrenic patients will be randomized to a Pentoxifylline (400 mg twice a day) or placebo treatment for six weeks. Pentoxifylline and placebo will be added to the current antipsychotic drug treatment. Participants will be asked to fill a socio-demographic questionnaire and to undergo a clinical differential diagnosis using the Symptoms Check List (SCL)-90, Clinical Global Impression (CGI), positive and negative symptoms scale (PANSS), and Hamilton depression rating scale (HAM-D). Following baseline evaluation, participants will be monitored for symptoms every two weeks until the end of the trial (overall three visits) using CGI, PANSS, and HAM-D. Adverse effects will be documented every visit using the Treatment Emergent Symptom Scale. Finally, yet importantly, a blood sample will be collected at baseline and every two weeks until the end of the trial to study the treatment effect on inflammatory markers.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pentoxifylline

Pentoxifylline (Oxopurin 400 mg)

Group Type: ACTIVE_COMPARATOR

Oxopurin

Intervention Type: DRUG

Subjects will receive two capsules per day.

Placebo

Placebo (105 mg Lactose and 510 mg Dextrose)

Group Type: PLACEBO_COMPARATOR

Oxopurin

Intervention Type: DRUG

Subjects will receive two capsules per day.

Interventions

Oxopurin

Subjects will receive two capsules per day.

Intervention Type: DRUG

Other Intervention Names

Pentoxifylline

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ben-Gurion University of the Negev

OTHER

Sponsor Role: collaborator

Mazra Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mazor MHC

Acre, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Alon Shamir, Ph.D.

Role: CONTACT

alons@mazor.health.gov.il

+97249954708

Facility Contacts

Alon Shamir, Ph.D

Role: primary

alons@mazor.health.gov.il

+97249954708

Other Identifiers

03-019-MZR

Identifier Type: -

Identifier Source: org_study_id