]>
IRCT20190321043096N1 IRCT 2019-04-23 Gorgan University of Medical Sciences Evaluation of the Effect of Ondansetron as Additional Drug on Reducing Negative Symptoms in Hospitalized and Outpatient with Schizophrenia Disorders بررسی تأثیر اندانسترون بعنوان داروی کمکی در اختلال اسکیزوفرنیا Evaluation of the Effect of Ondansetron as Additional Drug on Reducing Negative Symptoms in Hospitalized and Outpatient with Schizophrenia Disorders 2019-04-09 anticipated 30 Complete https://irct.ir/trial/38646 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Use random number tables At the beginning of the study, each patient was assigned a code that was recorded on the patient's questionnaire. Then, using the random numbers table and the registered codes, the patients in the intervention group were selected and the remaining patients were assigned to the control group, Blinding description: 1- subject coding 2- use of placebo is similar to the original medicine. 3 Schizophernia. Intervention 1: Intervention group: This group receive risperidone as an antipsychotics. Besides that intervention group will receive andonestrone. The dose of ondansetron is 4 mg in the first week and will reach 8 mg in the coming weeks. All subjects at the onset of the study, at weeks 0, 6, 8 and 12, will be evaluated for negative symptoms of schizophrenia by the PANSS scoring scale. Intervention 2: Control group: this group receive risperidone as an antipsychotics. The control group will receive the placebo. The dose of placebo is 4 mg in the first week and will reach 8 mg in the coming weeks. All subjects at the onset of the study, at weeks 0, 6, 8 and 12, will be evaluated for negative symptoms of schizophrenia by the PANSS scoring scale. Yes - There is a plan to make this available What will be shared: The main consequence of the study is the ability to share When: Two month To whom: Academic Institutions and Psychiatric Clinics Conditions: Improvement in the treatment of schizophrenia Where to obtain: Gorgan University of Medical Sciences How to obtain: Corresponding with the supervisor Comments:
public Hedye Mahmodi
Moslem 19
Mashhad Iran (Islamic Republic of) ۴۴۸۱۶۵۶۷۶۱ +98 51 3605 7872 mitrajudy@goums.ac.ir Gorgan University of Medical Sciences scientific Hedye Mahmoudi
Moalen19
Mashhad Iran (Islamic Republic of) ۴۴۸۱۶۵۶۷۶۱ +98 51 3605 7872 Pazohesh.3397@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) age of 18-65 No physical illness No alcohol or drug abuse The absence of pregnancy and lactation in women PANSS score of more than 15 Acceptance of written consent 18 years 65 years Both Drug abuse or alcohol abuse Breastfeeding and pregnancy women The need for other psychotropic drugs during the study F20.9 Schizophrenia, unspecified Treatment - Drugs Placebo Intervention group: This group receive risperidone as an antipsychotics. Besides that intervention group will receive andonestrone. The dose of ondansetron is 4 mg in the first week and will reach 8 mg in the coming weeks. All subjects at the onset of the study, at weeks 0, 6, 8 and 12, will be evaluated for negative symptoms of schizophrenia by the PANSS scoring scale. Control group: this group receive risperidone as an antipsychotics. The control group will receive the placebo. The dose of placebo is 4 mg in the first week and will reach 8 mg in the coming weeks. All subjects at the onset of the study, at weeks 0, 6, 8 and 12, will be evaluated for negative symptoms of schizophrenia by the PANSS scoring scale. Earn score 7-49 in the test of N-PANSs. Timepoint: Before starting the study and 6, 8 and 12 weeks after starting the study. Method of measurement: Based on DSM-5. Negative symptoms of schizophrenia. Timepoint: Weeks of 0, 6, 8 and 12. Method of measurement: Evaluation Scale of PANSS. Gorgan University of Medical Sciences Approved 2018-09-22 Golestan Golestan University of Medical Sciences Moslem 19 Mashhad Razavi Khorasan Iran (Islamic Republic of)