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IRCT20120314009297N7 IRCT 2020-05-20 Mazandaran University of Medical Sciences The effect of ondansetron in patients with residual schizophrenia Study of the efficacy and safety of ondansetron as an adjuvant to antipsychotics in patients with chronic schizophrenia: A randomized, double-blind, placebo-controlled trial 2020-05-21 anticipated 30 Complete https://irct.ir/trial/48250 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced block randomization, Blinding description: ondansetron and placebo tablets are completely similar in terms of color, size, smell and taste produced by a completely similar manufacturing and packagings. Patients were randomly tested in groups. Until the end of the study, no patient or study persons are aware of which drug the patient receives. And anybody other than those who are defective in the study is aware. 3 Schizophrenia with residual symptoms. Intervention 1: Intervention group: Previous prescription antipsychotic treatment + ondosterone drug at a dose of 4 mg per day for the first week and 8 mg per day (in two divided doses) for the second week and 12 mg per day ( They are given in three divided doses) for the third week to the end of the study (if patients tolerate it). Intervention 2: Control group: Previous prescription antipsychotic treatment + placebo which is similar to the ondansteron pill in terms of shape, smell, taste, size and color, on a daily basis. 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 I haven't decided yet - the release schedule is not clear yet
public Narjes Hendouei
20th Km Farahabad Road, Payambar Azam Academic Complex
Sari Iran (Islamic Republic of) 33971-48157 +98 11 3354 2472 hendoieen@yahoo.com Mazandaran University of Medical Sciences scientific Narjes Hendouei
20th Km Farahabad Road, Payambar Azam Academic Complex
Sari Iran (Islamic Republic of) 33971-48157 +98 11 3354 2472 hendoieen@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 18-65 years old male patients Patients with a diagnosis of schizophrenia based on DSM-5 criteria for at least two years who should still be symptomatic despite treatment with antipsychotic medications. Patients should be treated with antipsychotic medications for at least one year, and the type and dose of their antipsychotic medications should remain constant for the last three months. If they are taking medications such as mood stabilizers or antidepressants with their antipsychotic treatment regimen, their type and dose will remain the same for three months before the start of the study and during the study. If they are taking anticholinergic drugs (which include bipyridine or trihexylphenidyl) in combination with their antipsychotic treatment regimen for treatment or prevention the Movement side effects of antipsychotics, the type and dose of them remain stable for three months before the start of and during the study. 18 years 65 years Male Going to the acute phase of the disease means a 20% increase in the overall score of PANSS (Scizospheria positive and negative evaluation criteria) Patients with acute suicidal behavior or a history of suicide last year, associated psychiatric disorders such as schizo-effective or other psychotic disorders, mental retardation or other cognitive impairment, bipolar disorder and depression, anxiety disorders such as current panic disorder or obsessive-compulsive disorder, Post-traumatic stress disorder, eating disorder History of substance abuse dependence (substance dependence criteria DSM-5) or abuse of substances in the three months prior to the start of the study or positive urine screening test for the substance at the beginning of the study. Patients under ECT in the last six months People with thoughts or actions to harm themselves or others during the study or in the 6 months before the study Patients with neurological disorders such as dementia, delirium, uncontrolled seizures, head trauma, seizure disorder (other than fever-related) and neurodegenerative diseases (such as Alzheimer's, Parkinson's, Stroke, and multiple sclerosis) People with conduction disorders of the heart and other medical / uncontrolled underlying diseases Patients with a history of NMS Patients treated with drugs that affect the patient's cognitive status are based on the criteria of Drugs on the Anticholinergic Burden (ACB) scale (17), such as drugs with anticholinergic properties (except biperidin and trihexifenidyl), hypnotic antihistamines. , Antidepressants Patients with sensitivity to androsterone or other components of the drug or placebo Patients with endangered drug use in the last 6 months F20.5 Residual schizophrenia Treatment - Drugs Placebo Intervention group: Previous prescription antipsychotic treatment + ondosterone drug at a dose of 4 mg per day for the first week and 8 mg per day (in two divided doses) for the second week and 12 mg per day ( They are given in three divided doses) for the third week to the end of the study (if patients tolerate it) Control group: Previous prescription antipsychotic treatment + placebo which is similar to the ondansteron pill in terms of shape, smell, taste, size and color, on a daily basis. Score of general, positive and negative symptoms with Positive and Negative Symptom Scale (PANSS). Timepoint: At baseline and the end of each month. Method of measurement: Positive and Negative Symptom Scale (PANSS). Score of change in severity of illness based on Clinical Global Impression – Improvement (CGI-I). Timepoint: At the end of each month. Method of measurement: Clinical Global Impression -Improvement (CGI-I) score. Score of severity of illness based on Clinical Global Impression of Severity (CGI-S). Timepoint: At baseline and at the end of each months. Method of measurement: Clinical Global Impression off Severity (CGI-S). Score of depression symptoms based on Calgary Depression Scale for Schizophrenia. Timepoint: At baseline and at the end of each months. Method of measurement: Brief Assessment of Cognition in schizophrenia. Score of SAS for extra pyramidal side effects. Timepoint: At baseline and at the end of each months. Method of measurement: Simpson-Angus Scale (SAS). Score of Barnes Akathisia Rating Scale (BARS). Timepoint: At baseline and at the end of each months. Method of measurement: Barnes Akathisia Rating Scale (BARS). Score of Abnormal Involuntary Movement Scale (AIMS). Timepoint: At baseline and at the end of each months. Method of measurement: Abnormal Involuntary Movement Scale (AIMS). Mazandaran University of Medical Sciences Approved 2020-05-04 Ethics committee of Mazandaran University of Medical Sciences Moallem street, Moallem square, Vice chancellor for research sari Mazandaran Iran (Islamic Republic of)