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IRCT20210409050910N2 IRCT 2022-04-13 Sabzevar University of Medical Sciences The effect of betahistine on prevention of olanzapine-induced weight gain in patients with psychotic disorder The effect of betahistine on prevention of olanzapine-induced weight gain in patients with psychotic disorder 2021-05-22 anticipated 120 Complete https://irct.ir/trial/55510 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is performed as a clinical trial on psychotic patients under standard treatment with olanzapine referred to the medical center of Vasei hospital in Sabzevar after the approval of the ethics committee and obtaining informed written consent of patients referred to the psychiatric clinic of Vasei hospital under the supervision of psychiatric professors. People who have been diagnosed with psychosis according to the DSM5 criteria and are being treated with olanzapine will be selected. After randomization, we will have 60 people in the intervention group (olanzapine + betahistine) and 60 people in the control group (olanzapine alone). Patients in both groups take 5 to 10 mg of olanzapine daily for 73 days, and in these 73 days in the intervention group betahistine at a dose of 8 mg twice a day (16 mg daily) with the start of treatment at the end of treatment in the group. Intervention and in the control group, weight is measured with a specific scale and waist circumference is measured with a meter, and the two groups are compared in terms of weight and waist changes. 2-3 Psychosis. Intervention 1: Intervention group: Routine treatment + betahistine, patients take 5 to 10 mg of olanzapine daily for 73 days and in these 73 days in the intervention group, betahistine 8 mg twice a day (16 mg daily) with olanzapine will be used. Intervention 2: Control group: Routine treatment, Patients take 5 to 10 mg of olanzapine daily for 73 days. 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 Its release schedule is not yet known
public Hossein Fahimi
Sabzevar, Nuclear Martyrs Boulevard, Extensive Educational Hospital
Sabzevar Iran (Islamic Republic of) 9617747431 +98 51 4465 1300 hossein1fahimi@gmail.com Sabzevar University of Medical Sciences scientific Hossein Fahimi
Sabzevar, Nuclear Martyrs Boulevard, Extensive Educational Hospital
Sabzevar Iran (Islamic Republic of) 9617747431 +98 51 4465 1300 hossein1fahimi@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Not all people with psychosis are treated with olanzapine and do not take effective histamine receptors (antihistamines, etc.). no limit no limit Both Patients with concomitant metabolic diseases Patients who are obese. Patients taking other weight gain drugs (such as clozapine) at the same time. F29 Unspecified psychosis not due to a substance or known physiological condition Treatment - Drugs Treatment - Drugs Intervention group: Routine treatment + betahistine, patients take 5 to 10 mg of olanzapine daily for 73 days and in these 73 days in the intervention group, betahistine 8 mg twice a day (16 mg daily) with olanzapine will be used. Control group: Routine treatment, Patients take 5 to 10 mg of olanzapine daily for 73 days. Weight: The rate of weight gain in control and intervention groups. Timepoint: Start treatment, weeks 4 and 8 and end treatment. Method of measurement: Scales. Waist circumference: The rate of increase in waist circumference in control and intervention groups. Timepoint: Start treatment, weeks 4 and 8 and end treatment. Method of measurement: Meter. Sabzevar University of Medical Sciences Approved 2020-02-10 Ethics committee of Sabzevar University of Medical Sciences Road of Tohid shar- Pardis of Sabzevar University of Medical Sciences Sabzevar Razavi Khorasan Iran (Islamic Republic of)