This study was designed to evaluate the effectiveness of the Famotidine on symptoms of schizophrenic patients as a clinical trial.
Design
Clinical trials with a control groups, parallel groups.
After sampling, samples are randomly assigned to a control group and intervention group(64 patients with schizophrenia, phase 3) .
Settings and conduct
The target population of this study will be 64 hospitalized patients with schizophrenia who referred to the Shafa hospital in Rasht. Patients will be selected by a psychiatrist based on Diagnostic and Statistical Manual of Psychiatric Disorders (DSM5) clinical interviews. After obtaining informed consent, the patients will be included in the study with sampling method, observing inclusion and exclusion criteria. After sampling, samples are randomly assigned to a control group and intervention group. Individuals in intervention group receive standard Psychiatric medication (Olanzapine at a dosage of 10 to 25 mg, daily) and for 6 weeks a Famotidine. The effectiveness of the treatment will be evaluated in Baseline and Six weeks after the intervention based on the score obtained from the Wechsler Memory Scale(WMS) and Positive and Negative Symptoms of Schizophrenia(PANSS).
Participants/Inclusion and exclusion criteria
The diagnosis of schizophrenia based on Diagnostic and Statistical Manual of Psychiatric Disorders (DSM5), Patients receiving second-generation drugs
Intervention groups
Intervention group: Individuals in intervention group will receive for 6 weeks a Famotidine ( 40 mg, daily). Also patients will receive their standard Psychiatric medication(Olanzapine at a dosage of 10 to 25 mg, daily).
Control group: Individuals in control group will receive their standard Psychiatric medication (Olanzapine at a dosage of 10 to 25 mg, daily).
Main outcome variables
symptoms of schizophrenic patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190707044123N1
Registration date:2019-07-15, 1398/04/24
Registration timing:prospective
Last update:2019-07-15, 1398/04/24
Update count:0
Registration date
2019-07-15, 1398/04/24
Registrant information
Name
Ali Pourramzani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 6268
Email address
ali.pourramazani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-16, 1398/04/25
Expected recruitment end date
2019-08-16, 1398/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial on the effectiveness of the Famotidine on symptoms of schizophrenic patients
Public title
Clinical trial on the effectiveness of the Famotidine on symptoms of schizophrenic patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The diagnosis of schizophrenia based on Diagnostic and Statistical Manual of Psychiatric Disorders (DSM5)
Patients receiving second-generation drugs
A year past diagnosis of schizophrenia
Patients have a secondary school education
Exclusion criteria:
Sensitivity to famotidine
Drug abuse
Serious medical illness (Nephrology disease)
Age
From 25 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
After convenience sampling, Participants will be assigned to three groups of 32 people using closed envelopes with blocked randomization method. Blocking will be used to create the
number of samples assigned to each treatment group. In this study, people will be divided into 16 blocks of 4. Patients with the ability to enter this clinical trial are categorized as 1 to 1 in two groups of intervention and control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Deputy of Research and Technology University, The old building of the School of Health, in front of 17 shahrivar Hospital, Shahid Siadati St., Namjoo St.
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.GUMS.1398.132
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Symptoms of schizophrenia
Timepoint
The effectiveness of the treatment will be evaluated in Baseline and Six weeks after the intervention.
Method of measurement
The effectiveness of the treatment will be evaluated in Baseline and Six weeks after the intervention based on the score obtained from the Wechsler Memory Scale(WMS) and Positive and Negative Symptoms of Schizophrenia(PANSS).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individuals in intervention group will receive for 6 weeks a Famotidine ( 40 mg, daily). Also patients will receive their standard Psychiatric medication(Olanzapine at a dosage of 10 to 25 mg, daily).
Category
Treatment - Drugs
2
Description
Control group: Individuals in control group will receive their standard Psychiatric medication (Olanzapine at a dosage of 10 to 25 mg, daily).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Dr Ali Pourramzani
Street address
15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
ali.pourramazani@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Ali Pourramzani
Street address
15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
ali.pourramazani@gums.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mona Mousaei
Position
Reseacher staff
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
monamusaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Ali Pourramzani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
ali.pourramazani@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mona Mousaei
Position
Research staff
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
monamusaie@yahoo.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as the key outcome information or the like, can share.
When the data will become available and for how long
The beginning of the access period since early 2020
To whom data/document is available
It will be available to doctors and researchers working in academic and academic institutions.
Under which criteria data/document could be used
Eligible persons can send their application by e-mail to access relevant information so that they can be sent to them if they identify the project implementer.
From where data/document is obtainable
Email to head of project
What processes are involved for a request to access data/document
After the email is submitted to the head of project, the requesting person will receive the response within a few days.