Pentoxifylline Add-on Therapy for Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Oxopurin
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Mazor MHCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Pentoxifylline
Placebo
Arm Description
Pentoxifylline (Oxopurin 400 mg)
Placebo (105 mg Lactose and 510 mg Dextrose)
Outcomes
Primary Outcome Measures
Positive and negative symptoms
Improvement in positive and negative symptoms (Changes in PANSS rates)
Secondary Outcome Measures
Depressive symptoms
Changes in HAM-D rates
Full Information
NCT ID
NCT05073640
First Posted
September 29, 2021
Last Updated
September 29, 2021
Sponsor
Mazra Mental Health Center
Collaborators
Ben-Gurion University of the Negev
1. Study Identification
Unique Protocol Identification Number
NCT05073640
Brief Title
Pentoxifylline Add-on Therapy for Schizophrenia
Official Title
Pentoxifylline Add-on Therapy for Schizophrenia: A Randomized, Placebo-controlled, Double-blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2019 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mazra Mental Health Center
Collaborators
Ben-Gurion University of the Negev
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pentoxifylline
Arm Type
Active Comparator
Arm Description
Pentoxifylline (Oxopurin 400 mg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (105 mg Lactose and 510 mg Dextrose)
Intervention Type
Drug
Intervention Name(s)
Oxopurin
Other Intervention Name(s)
Pentoxifylline
Intervention Description
Subjects will receive two capsules per day.
Primary Outcome Measure Information:
Title
Positive and negative symptoms
Description
Improvement in positive and negative symptoms (Changes in PANSS rates)
Time Frame
Subjects will be monitored at baseline and every two weeks for six weeks
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
Changes in HAM-D rates
Time Frame
Subjects will be monitored at baseline and every two weeks for six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alon Shamir, Ph.D.
Phone
+97249954708
Email
alons@mazor.health.gov.il
Facility Information:
Facility Name
Mazor MHC
City
Akko
ZIP/Postal Code
25201
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alon Shamir, Ph.D
Phone
+97249954708
Email
alons@mazor.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Pentoxifylline Add-on Therapy for Schizophrenia
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