The efficacy of pentoxifylline adjunctive therapy on cognitive deficits and symptoms of patients with schizophrenia: A randomized placebo-controlled clinical trial
Improving symptoms and cognitive function level in schizophrenic patients
Design
A randomized, double-blind, placebo-controlled clinical trial in phase 3 clinical trials with parallel groups of 26 patients in each group
Settings and conduct
This study is performed on 52 patients with schizophrenia admitted to Ibn-Sina hospital in Mashhad. The treatment is completely blind and the patient, therapist and evaluator are not aware of the type of drug. Pentoxifylline tablets are added to the treatment regimen of a group of patients with schizophrenia and their effects are evaluated by tests performed at baseline, 4 and 8 weeks after treatment.
Participants/Inclusion and exclusion criteria
Patients 18-55 years in the hospital who were diagnosed with schizophrenia by their psychiatrist and confirmed by a psychiatric assistant with a structured interview based on DSM-5, completed the entry and exit conditions, and the patient or the patient's legal guardian has given consent to enter the study
Intervention groups
Assessment tests are first performed by the evaluator and psychiatric assistant, then patients in both groups are treated with standard schizophrenia's treatment including 2nd generation antipsychotics (including risperidone to 6mg, or olanzapine to 30mg or aripiperazole to 30mg) and benzodiazepine, anticholinergic and betablocker if needed. Patients are also randomly divided into 2 groups of drug and placebo using random numbers table.
One group receive 400 mg of pentoxifylline, 3 times daily for 8 weeks, and the other group receive placebo 3 times daily for 8 weeks. Initial evaluation tests are repeated for 4 to 8 next weeks.
Main outcome variables
Positive and negative symptoms of schizophrenia; Cognitive impairments
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190914044769N1
Registration date:2020-03-07, 1398/12/17
Registration timing:registered_while_recruiting
Last update:2020-03-07, 1398/12/17
Update count:0
Registration date
2020-03-07, 1398/12/17
Registrant information
Name
Farideh Sinichi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3846 6701
Email address
sinichif971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of pentoxifylline adjunctive therapy on cognitive deficits and symptoms of patients with schizophrenia: A randomized placebo-controlled clinical trial
Public title
Effect of Pentoxifylline in treatment of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of schizophrenia based on DSM-5 criteria
Patients aged 18-55 years
Completion of the consent form by the patient or his / her family
Education level at least eighth grade
Absence of other concurrent psychiatric disorders
Absence of liver and kidney disorders
Absence of medical illness leads to psychiatric symptoms
No substance use except for smoking
Absence of serious cognitive impairment
Absence of risk factor for bleeding
Patients who are prescribed antipsychotics for risperidone, olanzapine or aripiperazole.
Onset of illness under 45 years
Exclusion criteria:
Hypersensitivity reaction or any unbearable side effect caused by the drug
Unwillingness to continue taking the drug and continue the project
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs and placebo are packaged and numbered by the pharmacist and provided to the researcher and then the therapeutic units. Study participants were unaware that the drug they were taking was a drug or a placebo, knowing that the drug was added to other drugs to improve their condition. The lead researcher, who drafts the article, entered the patients and prescribed the medication in their prescription don't know which patients are given the drug or placebo. Nurses who take care of patients and give patients drugs have been kept blind in the study because they give the medicine from the same numbered envelopes to the patients, and the doctors who check the medication's side effects; They have been kept blind from the study. Data collectors and those assessing outcomes also lack information on drug and placebo groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran national committee for ethics in biomedical research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
9999999999
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.821
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
cognitive scores according to Stroop, Ray, Digit span, and Wisconcin card sorting test
Timepoint
Evaluation of cognitive impairments and positive and negative symptoms of schizophrenia at baseline (before intervention) and 4 and 8 weeks after starting pentoxifylline
Method of measurement
Positive and Negative Syndrome Scale, cognitive tests include Stroop, Ray, Digit span, and Wisconcin card sorting test
Secondary outcomes
1
Description
score of Positive and Negative Syndrome Scale
Timepoint
Baseline (before intervention) and 4 and 8 weeks after starting pentoxifylline
Method of measurement
Positive and Negative Syndrome Scale
Intervention groups
1
Description
To the intervention group is given 400mg extended release pentoxifylline pills from Hakim Pharmaceutical Company every 8 hours for 2 months. Pentoxifylline is a class of aminophyllins.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebn-Sina hospital
Full name of responsible person
Farhad Faridhoseini
Street address
Bou-Ali square., Hor Ameli blvd., Ibn-Sina hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3700 2201
Email
faridhoseinif@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Psychiatry and Behavioral Sciences Research Center
Street address
Bou-Ali square., Hor Ameli blvd., Ibn-Sina hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2540
Fax
Email
Faridhoseinif@mums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
70
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fsrhad Faridhoseini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Bou-Ali square., Hor Ameli blvd., Ibn-Sina hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 337002201
Email
faridhoseinif@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farhad Faridhoseini
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Bou-Ali square., Hor Ameli blvd., Ibn-Sina hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 337002201
Email
FaridhoseiniF@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
فریده سینی چی
Position
Assisstant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Bou-Ali Square., Hor Ameli Blvd., Ibn-Sina Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 337002201
Email
sinichif971@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The full statistical report will be published in detail on the data of the questionnaires in the paper.
When the data will become available and for how long
from 2020
To whom data/document is available
The data report will be published in the article.
Under which criteria data/document could be used
The data report will be published in the article.
From where data/document is obtainable
The data report will be published in the article.
What processes are involved for a request to access data/document