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IRCT20200430047250N1 IRCT 2020-09-11 Kermanshah University of Medical Sciences Evaluation of the efficacy of Olanzapine and Aripiprazole in patients with psychotic disorders A comparative study of the effectiveness and safety of Aripiprazole and Olanzapine in patients with psychotic disorders; A clinical trial 2020-07-18 anticipated 94 Complete https://irct.ir/trial/48918 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Blinded individuals include: Participants Trialist (project executive) Patients Health staff outcome adjudicators Data Analysts. 2 Psychotic Disorders. Intervention group: This study is a double-blind clinical trial. The study population includes all patients with psychotic disorders who in 1398, referred to Farabi Hospital in Kermanshah for treatment and have the criteria for inclusion in the study Inclusion criteria in this study include (diagnosis of psychotic disorders based on clinical interview and DSMv criteria and ICSD-III by a psychiatrist 2) Prescribing aripiprazole or olanzapine as a treatment strategy for psychotic disorders by a psychiatrist 3) In the age range of 18-64 years and exclusion criteria are also 1) People who take drugs such as hypnotics Take concomitantly with aripiprazole or olanzapine (drugs that have high sedative effects) 2) Patients who are abused or dependent on aripiprazole or olanzapine, 3) Patients with concomitant chronic physical illnesses such as diabetes, hypertension, And rheumatism 4) patients who are medically prohibited from taking aripiprazole or olanzapine. After explaining the purpose of the study, and obtaining informed consent, patients are randomly divided into two groups based on a table of random numbers. First, tests related to the presence or absence of metabolic syndrome, including blood sugar, blood lipids, etc. are taken from these people. Also, in order to measure body mass (BMI), height and weight of people are measured. Then, one of the members of the research team, who randomizes two groups of blinds, poses a questionnaire of positive and negative symptoms (PANSS) of these people. Becomes. In the next step, the psychiatrist prescribes one of the two drugs olanzapine and eripiprazole for the patient and provides the patient with the amount of the drug for one month. Also, the contact number is provided to the patient so that in case of any problem, he can discuss it with the psychiatrist. During the first month, patients are contacted once a week and asked about side effects. After one month, the contact number that was initially taken from the patient will be called and he will be asked to visit again. During this visit, the psychiatrist re-examines the patient and returns the medication. During this visit, the patient is sent back to the laboratory and the first stage tests are repeated for him. Also, his height and weight are re-evaluated by the first stage assessor to control body mass and PANSS questionnaire and side effects checklist based on DSMv Prepared is completed. Since the time required for the effect of these drugs is eight weeks or two months (14) after another month, ie after the end of two months, the patient is contacted again and the patient evaluation cycle, which was performed at the end of the first month, is repeated. Is repeated. It should be noted that if at the end of a month or the second month the patient has side effects or metabolic syndrome, the psychiatrist can change the patient based on the clinical condition. It is also used to control confounding variables such as the patient's arbitrary use of other drugs or to reduce the amount of drugs arbitrarily by calling the patient and reminding them. After two months, the information is entered in SPSS20 software and analyzed using statistical tests.. 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 There is no more information
public Nima Gheitouly
No48, bostan Ave, Roodaki Blvd, Kermanshah Town
Kermanshah Iran (Islamic Republic of) 6714847691 +98 83 3428 3987 nimagheitouly@yahoo.com Kermanshah University of Medical Sciences scientific Nima Gheitouly
No48, bostan Ave, Roodaki Blvd, Kermanshah Town
Kermanshah Iran (Islamic Republic of) 6714847691 +98 83 3428 3987 nimagheitouly@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Diagnosing psychotic disorders through clinical interview and DSM-5 & ICSD-III criteria Prescribing Aripiprazole or Olanzapine as a treatment strategy for psychotic disorders Patients aged 18-64 years 18 years 64 years Both Patients simultaneously taking medications such as sleeping pills and Aripiprazole or Olanzapine (drugs that have high sedative effects) Patients suffering dependence on or abuse of Aripiprazole or Olanzapine Patients with multiple chronic physical illnesses such as Diabetes, High Blood Pressure, and Rheumatism Patients with certain health conditions( preventing them form taking Aripiprazole or Olanzapine ) Treatment - Drugs Intervention group: This study is a double-blind clinical trial. The study population includes all patients with psychotic disorders who in 1398, referred to Farabi Hospital in Kermanshah for treatment and have the criteria for inclusion in the study Inclusion criteria in this study include (diagnosis of psychotic disorders based on clinical interview and DSMv criteria and ICSD-III by a psychiatrist 2) Prescribing aripiprazole or olanzapine as a treatment strategy for psychotic disorders by a psychiatrist 3) In the age range of 18-64 years and exclusion criteria are also 1) People who take drugs such as hypnotics Take concomitantly with aripiprazole or olanzapine (drugs that have high sedative effects) 2) Patients who are abused or dependent on aripiprazole or olanzapine, 3) Patients with concomitant chronic physical illnesses such as diabetes, hypertension, And rheumatism 4) patients who are medically prohibited from taking aripiprazole or olanzapine. After explaining the purpose of the study, and obtaining informed consent, patients are randomly divided into two groups based on a table of random numbers. First, tests related to the presence or absence of metabolic syndrome, including blood sugar, blood lipids, etc. are taken from these people. Also, in order to measure body mass (BMI), height and weight of people are measured. Then, one of the members of the research team, who randomizes two groups of blinds, poses a questionnaire of positive and negative symptoms (PANSS) of these people. Becomes. In the next step, the psychiatrist prescribes one of the two drugs olanzapine and eripiprazole for the patient and provides the patient with the amount of the drug for one month. Also, the contact number is provided to the patient so that in case of any problem, he can discuss it with the psychiatrist. During the first month, patients are contacted once a week and asked about side effects. After one month, the contact number that was initially taken from the patient will be called and he will be asked to visit again. During this visit, the psychiatrist re-examines the patient and returns the medication. During this visit, the patient is sent back to the laboratory and the first stage tests are repeated for him. Also, his height and weight are re-evaluated by the first stage assessor to control body mass and PANSS questionnaire and side effects checklist based on DSMv Prepared is completed. Since the time required for the effect of these drugs is eight weeks or two months (14) after another month, ie after the end of two months, the patient is contacted again and the patient evaluation cycle, which was performed at the end of the first month, is repeated. Is repeated. It should be noted that if at the end of a month or the second month the patient has side effects or metabolic syndrome, the psychiatrist can change the patient based on the clinical condition. It is also used to control confounding variables such as the patient's arbitrary use of other drugs or to reduce the amount of drugs arbitrarily by calling the patient and reminding them. After two months, the information is entered in SPSS20 software and analyzed using statistical tests. Measurement of body mass index in psychotic patients treated with olanzapine or aripiprazole. Timepoint: At the beginning of the study and one and two months after starting the drug. Method of measurement: Height and weight scales. Efficacy of olanzapine and aripiprazole in psychotic patients. Timepoint: At the beginning of the study and one and two months after starting the drug. Method of measurement: PANSS Questionnaire. Kermanshah University of Medical Sciences Approved 2020-07-18 Ethics committee of Kermanshah university of medical sciences No48 ,Boostan Ave ,Roodaki Blvd, Kermanshah Town Kermanshah Kermanshah Iran (Islamic Republic of)