NCT04094207

Brief Summary

The aim of this study to evaluate the efficacy and safety of pentoxifylline, the novel phosphodiesterase inhibitor, as an adjunctive to risperidone in alleviating the negative symptoms of schizophrenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 schizophrenia

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

2.7 years

First QC Date

September 15, 2019

Last Update Submit

October 23, 2022

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Treatment-induced change in total score on Positive and Negative Syndrome Scale (PANSS)

    PANSS total score will be used to examine treatment-induced change in psychaopthology. The PANSS is a 30-item rating scale used to assess symptoms of psychopathology. We will use the total PANSS score as the primary outcome measure which reflects total level of psychopathology including the positive and negative symptoms as well as general psychopathology.This measure will be administered at baseline, week 8 and week 16 of the study to assess if pentoxifylline treatment results in a significant reduction in PANSS total score as opposed to placebo.

    Baseline to week 8 of the study

Secondary Outcomes (1)

  • Treatment-induced changes in plasma level of cytokines

    Baseline and week 8 of the study

Study Arms (2)

Control group

PLACEBO COMPARATOR

Equivalent Placebo will be given

Drug: Placebo oral tablet

Pentoxifylline group

EXPERIMENTAL

Pentoxifylline will be given orally at 800 mg a day for 8 weeks

Drug: Pentoxifylline

Interventions

Placebo oral tabletDRUG

Placebo tablets PLUS Risperidone 2 mg tablet up to 6 mg/day

Control group
PentoxifyllineDRUG

Pentoxifylline tablet PLUS Risperidone 2 mg tablet up to 6 mg/day

Pentoxifylline group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages between 18-40 years
  • Males \& females
  • patients between the ages of 18 and 53 who met the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (20), with a minimum disease duration of two years.
  • stable on risperidone for a minimum of 8 weeks
  • clinically stable for at least 4 weeks prior to study.
  • willing to give informed consent.
  • able to take medication orally.

You may not qualify if:

  • Acute, unstable, significant or untreated medical illness beside schizophrenia;
  • Pregnant or breast-feeding females;
  • History of substance abuse or dependence in the past 3 months.
  • Known contraindication to pentoxifylline treatment.
  • Any serious or life-threatening medical conditions or neurological problem, severe extrapyramidal symptoms, history of abnormal bleeding, presence of hypothyroidism, renal disease, cardiovascular problems, rising liver transaminases to 3 times the upper limit of normal or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Shibīn al Kawm, Egypt

Location

Related Publications (1)

  • Abdallah MS, Mosalam EM, Hassan A, Ramadan AN, Omara-Reda H, Zidan AA, Samman WA, El-Berri EI. Pentoxifylline as an adjunctive in treatment of negative symptoms in chronic schizophrenia: A double-blind, randomized, placebo-controlled trial. CNS Neurosci Ther. 2023 Jan;29(1):354-364. doi: 10.1111/cns.14010. Epub 2022 Nov 7.

    PMID: 36341700DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2019

First Posted

September 18, 2019

Study Start

January 1, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2022

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

EG(1)