The effect of adding Cilostazol to Treatment of Schizophrenic Patients in the cognition and Symptoms of Disease
Design
A double-blind, randomized clinical trial that is conducted on two groups of intervention and control including 60 patients with schizophrenia. Patients are followed for 8 weeks
Settings and conduct
The study is conducted at Ebne-sina Psychiatric Hospital in Mashhad. The study is double-blinded, the form of drug and placebo is the same, the rater and the patients are not aware of what treatment they are using. The drug is identified by the pharmacist in sealed envelopes with a numerical code.
Participants/Inclusion and exclusion criteria
60 schizophrenic patients
inclusion criteria:
1) Diagnosis of schizophrenia based on DSM-5 criteria.
2) aged 18-64 years.
3) Completion of the consent form by the patient or his family.
4) level of education at least 8th grade.
exclusion criteria:
1) Simultaneous psychiatric disorders.
2) Hepatic impairment (ALT and AST> 2.5ULN)
3) medical illness.
4) Use of substances other than cigarettes.
5) A hypersensitivity reaction or any intolerable side effects caused by the drugs.
6) Use of other interfering drugs.
7) Serious cognitive impairment.
8) Platelet problem with anticoagulant blood.
Intervention groups
In one group as double-blind, Cilostazol is given as a 25 mg dose twice a day for 2 weeks, then 50 mg for 6 weeks, and the other one is given placebo as in the intervention group, twice a day for 8 weeks
Main outcome variables
This study could lead to the introduction of auxiliary drug to complement the treatment of symptoms of schizophrenia and its cognitive impairment, with less complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180307038989N1
Registration date:2018-04-15, 1397/01/26
Registration timing:registered_while_recruiting
Last update:2018-04-15, 1397/01/26
Update count:0
Registration date
2018-04-15, 1397/01/26
Registrant information
Name
Maryam Naghibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3846 7502
Email address
naghibim941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-05, 1397/01/16
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding Cilostazol on cognitive deficits and symptoms of schizophrenic patients: a double-blind, randomized clinical trial
Public title
Effect of cilostazol on Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of schizophrenia based on DSM-5 criteria
aged 18-64 years
completed consent form by the patient or his family
at least the eighth grade education
Exclusion criteria:
Simultaneous psychiatric disorders
liver disorders
medical illness
Use of opioid substances other than cigarettes
A hypersensitivity reaction or any untoward side effects caused by the drug
Use of other interfering drugs
Serious cognitive impairment
blood or Platelet problem Contradictory with taking medication
Age
From 18 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who completed entry and exit conditions in the study based on random numbers table were randomly assigned to two groups of drugs and placebo
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blind: the form of drug and placebo is the same, and the evaluator, the patient and the analyst are not aware of what treatment they are using, and drug intervention is identified by the pharmacist in sealed envelopes with a numeric code.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Mashhad university of medical sciences
Street address
ghoreishi department, daneshgah ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9175845643
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
960175
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Score in PANSS questionnaire
Timepoint
Before starting the study and at times, 0, 2, 4 and 8 weeks after starting treatment
Before starting the study and at times, 0, 2, 4 and 8 weeks after starting treatment
Method of measurement
Digit span questionnaire
3
Description
Cognition scoring based on Wisconsin card sorting test
Timepoint
Before starting the study and at times, 0, 2, 4 and 8 weeks after starting treatment
Method of measurement
Wisconsin card sorting test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cilostazol tablets are orally administered at a dose of 25 mg twice daily for 2 weeks and then 50 mg twice daily for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: placebo tablets similar to Cilostazol are orally administered at a dose of 25 mg twice daily for 2 weeks and then 50 mg twice daily for 6 weeks.