ClinicalTrials.gg
Status unknownNCT05073640Updated Oct 11, 2021

Pentoxifylline Add-on Therapy for Schizophrenia

A Phase 1/2 interventional study of Oxopurin in Schizophrenia, sponsored by Mazra Mental Health Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-10-11.

Sponsored by Mazra Mental Health Center · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Apr 2019, registered Sep 2021).

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Phase
Phase 1/2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 112 studies in Schizophrenia with a site in Israel — 3 open to participants now, 4 under way, none of them phase 3. Schizophrenia · Israel.

Planned enrollment
30th of 88
90 · median 53
Started
2019
with 3 others
Phase 1/2
3 of 112
1 open now
Registered
102nd of 112
by date

Among the 112 studies in Schizophrenia with a site in Israel, this one is the 30th largest by planned enrollment of the 88 interventional ones that give a count, is one of 4 that started in 2019, is one of 3 in phase 1/2, and was the 102nd registered.

Schizophrenia

3,565 studies on the registry are indexed under Schizophrenia; 492 are open to participants now.

Browse Schizophrenia studies →

Open to participants now

3 of the 112 studies in Schizophrenia with a site in Israel are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →

Who these studies take

Of the 332 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 258 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Schizophrenia

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04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients meeting the 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

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 ( > 30).
  7. Cognitive dysfunction such as retardation.
  8. Known or suspected pregnancy or breastfeeding women.
  9. Lactose intolerance or sensitivity.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Pentoxifylline

    Pentoxifylline (Oxopurin 400 mg)

    Drug: Oxopurin

  • Placebo comparator
    Placebo

    Placebo (105 mg Lactose and 510 mg Dextrose)

    Drug: Oxopurin

Interventions

  • Subjects will receive two capsules per day.

    Also known as: Pentoxifylline

06

What researchers measure

Primary outcomes

  1. Positive and negative symptoms

    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 outcomes

  1. Depressive symptoms

    Changes in HAM-D rates

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2019 (actual). Primary completion is estimated for Apr 2022, 36 months after the start.

Of 18 phase 1/2 interventional studies under Schizophrenia, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 70. This study's planned 36 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2021
First posted
Oct 11, 2021
StartActual
Apr 20, 2019
Primary completionEst.
Apr 2022
CompletionEst.
Dec 2022
Last update
Oct 11, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05073640
Lead sponsor
Mazra Mental Health Center
Collaborators
Ben-Gurion University of the Negev
Responsible party
Sponsor
First posted
Oct 11, 2021
Start date
Apr 20, 2019
Primary completion
Apr 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Oct 11, 2021

Study contacts

Alon Shamir, Ph.D.
Contact
alons@mazor.health.gov.il
+97249954708

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Pentoxifylline

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