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IRCT20191223045870N1 IRCT 2020-03-13 Mashhad University of Medical Sciences Betahistine and Weight- Related and Metabolic Measures in schizophrenic Patients Treated with Olanzapin or Risperidone The Effect of Betahistine on Weight- related and Metabolic Measures in Patients with Schizophrenia Treated with Olanzapine and Risperidone 2020-06-09 anticipated 56 Complete https://irct.ir/trial/44644 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 Schizophrenia. Intervention 1: 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). Intervention 2: 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). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Waiting for Data
public Najme Abbasi Jannatabadi
Ebnesina Hospital.,Horeameli Ave.,Toos Blvd.,Mashhad Town
Mashhad Iran (Islamic Republic of) 9195983117 +98 51 3712 7017 Najmeabbasi84@yahoo.com Mashhad University of Medical Sciences scientific Mahsa Nahidi
Ebnesina Hospital.,Horeameli Ave.,Toos Blvd.,Mashhad Town
Mashhad Iran (Islamic Republic of) 9195983117 +98 51 3712 7017 nahidimh@ mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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) 18 years 59 years Both 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 F20 Schizophrenia Prevention Placebo 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). 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). 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. Fasting blood sugar. Timepoint: At the Begining of The Study And After 12 weeks. Method of measurement: Laboratory Glucose kit. 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. Thyroid stimulating hormone. Timepoint: At the Begining of The Study And After 12 weeks. Method of measurement: Enzyme linked immunosorbent test. Mashhad University of Medical Sciences Approved 2019-12-18 Ethics committee of Mashhad university of Medical Sciences Ebne sina Hospital.,Toos Blvd., Mashhad Town mashhad Razavi Khorasan Iran (Islamic Republic of)