Determining the effect of Cyproheptadine on reducing the positive and negative symptoms of schizophrenia patients based on Positive and Negative Syndrome Scale (PANSS) criteria.
Design
Two arm parallel group randomized trial with non blinded outcome assessment
Settings and conduct
In this randomized clinical trial, outpatients and inpatients of the psychiatric ward of Taleghani Hospital affiliated to Shahid Beheshti University of Medical Sciences, who were diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) and were randomly divided into two groups, will be included in the study. During this study, 30 patients with schizophrenia in two groups of 15 people (one group receiving Cyproheptadine and one control group) will be studied for 6 weeks and outcome will be measured in the first, second, fourth and sixth weeks of the study based on PANSS criteria
Participants/Inclusion and exclusion criteria
Inclusion criteria: ages 18-65 Diagnosis of schizophrenia or schizoaffective disorder (deppresive type) based on DSM-V
taking risperidone as an antipsychotic;
exclusion criteria:Antipsychotic treatment other than risperidone, Drug abuse, Thyroid disorder, pregnancy and lactation.
Intervention groups
Intervention group: receiving Cyproheptadine by dose of 8 mg per day in form of two 4mg tablet twice a day in addition to receiving risperidone 4-6 mg daily as an antipsychotic.
control group: receiving risperidone 4-6 mg daily as an antipsychotic
Main outcome variables
Positive and Negative symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003210N22
Registration date:2021-07-05, 1400/04/14
Registration timing:prospective
Last update:2021-07-05, 1400/04/14
Update count:0
Registration date
2021-07-05, 1400/04/14
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Cyproheptadine on relieving the negative and positive symptoms of patients with schizophrenia or schizoaffective
Public title
Cyproheptadine in Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18-65 years
Diagnosis of schizophrenia or schizoaffective disorder (Deppresive type) based on DSM-V
Taking Risperidone as an Antipsychotic
Fill in the consent
Exclusion criteria:
Antipsychotic treatment other than Risperidone
History of non-response to second generation antipsychotic treatment
Drug abuse
Thyroid Disorder
Pregnancy and Lactation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Individual Randomization with the Card in Two Groups A and B, in this Way a Number of Cards are selected as the first Intervention Group and the same Number in the control Group, then by merging the Cards together one Card is drawn and its Allocation is recorded and the Card is returned to the other Cards after it has been removed. The Cards are then re-merged and another Card is withdrawn. The Process continues until a Random Sequence Sample Size is reached.
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 Shahid Beheshti University of Medical Sciences
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2020-06-01, 1399/03/12
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.056
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Positive and Negative Syndrome
Timepoint
At the beginning of the study, the first week, the second week, the fourth week, the sixth week
Method of measurement
PANSS Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving Cyproheptadine by dose of 8 mg per day in form of two 4mg tablet twice a day in addition to receiving risperidone 4-6 mg daily as an antipsychotic.
Category
Treatment - Drugs
2
Description
Control group: receiving risperidone 4-6 mg daily as an antipsychotic
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani hospital
Full name of responsible person
Maria Tavakoli-Ardakani
Street address
Taleghani Educational Hospital, Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
mariatavakoli@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti School of Pharmacy, Hashemi Rafsanjani Highway ,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farnaz Kongi
Position
Student of Pharmacy
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti School of Pharmacy, Hashemi Rafsanjani Highway ,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
fariano.ko@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli Ardakani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti School of Pharmacy, Hashemi Rafsanjani Highway , Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
mariatavakoli@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farnaz Kongi
Position
Student of Pharmacy
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti School of Pharmacy, Hashemi Rafsanjani Highway ,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
fariano.ko@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available