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IRCT20210528051416N1 IRCT 2021-06-21 Ahvaz University of Medical Sciences Effect of melatonin in treatment of schizophrenia Evaluating the effect of melatonin on positive and negative symptoms of schizophrenic patients admitted to psychiatry ward of Golestan hospital in 2021-2022 2021-06-22 anticipated 46 Complete https://irct.ir/trial/56755 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the size of the blocks will be equal. The allocation method in each block will be disclosed using the blinding method. Patients admitted to the study in order of referral. Patients will be distributed in a ratio of 1: 1 and by 11 blocks (the length of each block is 4) (sample size of this study is 44). The randomization sequence will be created using the RandomBetween command in Excel, Blinding description: Patients will be treated with medication packages pre-determined by the study supervisor. The drug packages are quite similar in shape and the patient and the executor of the project are not aware of the contents of the packages. In addition, data collection, patient assessment, and completion of forms will be done by the project manager and her assistant who will not be aware of the content of the package. Data analysis will be performed by the project consultant and the project manager who will not be aware of the contents of the drug packages and only the patient group (group 1 or 2) will be identified for data analysis. Therefore, the study is double-blind and the contents of the two drug groups will not be clear in the patient admission to the study, data collection, and analysis stages. 3 schizophrenia. Intervention 1: Intervention group: patients will be treated with melatonin tablet (3 mg) which is prepared in RAZAK drug company. The intervention group will receive two melatonin tablets 3 mg (6 mg in total) 30 minutes before bedtime, for 6 weeks. Intervention 2: Control group: Patients will receive placebo tablets, which are similar to melatonin tablets (in shape, smell, taste, size and color) and are made from starch powder with the authorized color by the Pharmacy Laboratory of Ahwaz University of Medical Sciences, for 6 weeks. 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 specific plan for publish yet. There is no more information
public Sanam Anoosheh
Golestan hospital , Farvardin Blvd , Golestan
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3038 anoosheh.sanam@icloud.com Ahvaz University of Medical Sciences scientific Sanam Anoosheh
Golestan hospital , Farvardin Blvd , Golestan
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3038 anoosheh.sanam@icloud.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients who have admitted in psychiatry ward of Golestan hospital Age 18-65 years Schizophrenic patient according to DSM-5 Satisfaction of patients' guardianship Schizophrenic patients who have treated with risperidone 18 years 65 years Both Treatment with any psych medications except for risperidone Comorbidity of other psychopathologies Abuse of any substance, drug, or alcohol Drug reaction to melatonin or placebo Past history of treatment with clozapine or melatonin Pregnancy, mental retardation or any other neurologic and neurocognitive disorders, sleep apnea Proven depression according to Calgary scale Treatment with ECT in the current episode F20 Schizophrenia Treatment - Drugs Placebo Intervention group: patients will be treated with melatonin tablet (3 mg) which is prepared in RAZAK drug company. The intervention group will receive two melatonin tablets 3 mg (6 mg in total) 30 minutes before bedtime, for 6 weeks. Control group: Patients will receive placebo tablets, which are similar to melatonin tablets (in shape, smell, taste, size and color) and are made from starch powder with the authorized color by the Pharmacy Laboratory of Ahwaz University of Medical Sciences, for 6 weeks. Score of positive and negative symptoms according to PANSS scale. Timepoint: At the start of intervention, 3 weeks and 6 weeks later. Method of measurement: positive and negative syndrome scale. Ahvaz University of Medical Sciences Approved 2021-05-11 Ethics committee of Ahwaz University of Medical Sciences Golestan hospital , Farvardin Ave , Golestan Blvd Ahwaz Khouzestan Iran (Islamic Republic of)