Determine the Effect of Betahistine on Weight-related and Metabolic Measures in Patients with Schizophrenia Treated with Olanzapine and Risperidone
Design
Randomised,concealed, superiority ,parallel group clinical trial .This trial is double blind (for patients and researcher) ,and devided into two groups that each group has 28 patients.randomisation was done with site or excel software.
Settings and conduct
This Study is performed by Resident of psychiatry inSchizophrenic patients hospitalized and outpatints of Ebnesina Hospital and Hejazi Hospital who are taking Olanzapine or Risperidone.
They are randomly devided into intervention(resive Betahistine) or control group(resive Placebo).It'sDouble blinde . Patints and Researcher are not aware about drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
-Have Schizophrenia Based on DSM5
-18-59 years old
- Treated with Olanzapine or Risperidone that it dosen't Change during the Study
-Weight gain at least 7% of total body weight in the firs year ofvTreatment with Anti Psychotics or in a resent year
Exclusion criteria:
Pregnant or Lactating
Allergy to Betahistine
-Asthma,Peptic ulcer,Pheochromocytoma,Liver and Kidney Disfunction
Intervention groups
Patients are devided into two groups receiving Olanzapin and Resperidone . In both groups The entervention group treated with Betahistine (starting with 8 miligram and reaching 48 miligram within 11 days). The control group received Placebo wich is quite similar to Betahistine.
Main outcome variables
Weight,Waist and Hip circumfrence , BMI ,Fasting bllod sugar,, Lipid profile including cholesterol and triglyceride, Thyroid stimulating hormone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191223045870N1
Registration date:2020-03-13, 1398/12/23
Registration timing:prospective
Last update:2020-03-13, 1398/12/23
Update count:0
Registration date
2020-03-13, 1398/12/23
Registrant information
Name
Najmeh Abbasi Janet abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3879 1014
Email address
najmeabbasi84@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2021-12-11, 1400/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Betahistine on Weight- related and Metabolic Measures in Patients with Schizophrenia Treated with Olanzapine and Risperidone
Public title
Betahistine and Weight- Related and Metabolic Measures in schizophrenic Patients Treated with Olanzapin or Risperidone
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient or Legal Guardian Informed Consent
Have Schizophrenia Based on DSM5
18-59years old
Treated With Olanzapine or Risperidone That It Dosen't Change During The Study
Weight Gain At Least 7% Of Total Body Weight In The First Year of Treatment With Anti Psychotics Or In a Resent Year
If The Patient Is Taking Medication For Hyperlipidemia or Hypertention or Tyroid Disorders The Dose of Medication Did not Changed During The Study
The Patients Do not Have Another Medical or Psychiatric Disease
Do not Use Substance (Except Nicotine)
Exclusion criteria:
Have Asthma
Have Peptic Ulcer
Have Pheochromocytoma
Liver and Kidney Disfunction
Treated with Other Weight Related Medications Like Sodium Valproarte or Weight loss or Appetite Suppressant Medications
Have Allergy to Betahistine
Pregnant or Lactating
Age
From 18 years old to 59 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with inclusion criteria devided into two groups receiving risperidone or olanzapine.(Stratified randomization). Then random numbers selected for each group with Excel software or other randomization sites (Simple randomization) and packed in envelopes ( Allocation concealment).
Blinding (investigator's opinion)
Double blinded
Blinding description
For the patient with entry requirements after obtaining consent from him/her or him/her legal guardian an envelope is opened.Depending on the type of allocation of even / odd or A/B they fall into intervention or control group and medicine is given to the patient or his/her legal guardian and explained how to use that.The researcher records the patient's name, the date of first referral and the delivered product code.Patients do not know which group they are in.( Patients are blind).The researcher conducts follow- up as scheduled and she does not know which group the patien is in.
Placebo
Used
Assignment
Parallel
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
Ebne sina Hospital.,Toos Blvd., Mashhad Town
City
mashhad
Province
Razavi Khorasan
Postal code
۹۱۹۵۹۸۳۱۱۷
Approval date
2019-12-18, 1398/09/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.684
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Weight Related Measures(weight,waist and Hip circumfrence,BMI)
Timepoint
At The Begining of the Study Then Every Month
Method of measurement
Weight measure with scales, Waist and Hip circumference measure with Meter
2
Description
Fasting blood sugar
Timepoint
At the Begining of The Study And After 12 weeks
Method of measurement
Laboratory Glucose kit
3
Description
Lipid profile include cholesterol and tri glyceride
Timepoint
At the Begining of The Study And After 12 weeks
Method of measurement
Laboratory cholestrol and triglycerid kits
4
Description
Thyroid stimulating hormone
Timepoint
At the Begining of The Study And After 12 weeks
Method of measurement
Enzyme linked immunosorbent test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the intervention group received second generation of antipsychotics (Olanzapine or Risperidone) as a routine treatment and Betahistine (as an intervention), from 8 milligram then it would reach to 48 milligram in 11 days and it will remain in this dose until the end of the study (12 weeks).
Category
Prevention
2
Description
Control group: The control group received second generation of antipsychotics (Olanzapine or Risperidone) as a routine treatment Placebo (similar to Betahistine in shape and color) . (In order to keep patients blind in this study, as one Betahistine pill is added to intervention group every two days to achieve the 48 mg/d in 11th day of intervention, the number of placebo prescribed to control group would be increased till the eleventh day and then fixed till the end of the study).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebnesina Hospital
Full name of responsible person
Najmeh Abbasi Jannatabadi
Street address
Ebnesina Hospital.,Horeameli Ave.,Toos Blvd.,Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983117
Phone
+98 51 3712 7017
Email
Ebnesina.hos@mums.ac.ir
2
Recruitment center
Name of recruitment center
Hejazi Hospital
Full name of responsible person
Najmeh Abbasi Jannatabadi
Street address
63 Ebadi,Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983117
Phone
+98 51 3732 6767
Email
Ebnesina.hos@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ebnesina Hospital.,Horeameli Ave.,Toos Blvd.,Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983117
Phone
+98 51 3712 7017
Email
Najmeabbasi84@yahoo.com
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
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
Mashhad University of Medical Sciences
Full name of responsible person
Najme Abbasi Jannatabadi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ebnesina Hospital.,Horeameli Ave.,Toos Blvd.,Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983117
Phone
+98 51 3712 7017
Email
Najmeabbasi84@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Nahidi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ebnesina Hospital.,Horeameli Ave.,Toos Blvd.,Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983117
Phone
+98 51 3712 7017
Fax
Email
nahidimh@ mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Najmeh Abbasi Jannatabadi
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ebnesina Hospital.,Horeameli Ave.,Toos Blvd.,Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983117
Phone
+98 51 3712 7017
Email
Najmeabbasi84@yahoo.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