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IRCT20230619058537N1 IRCT 2023-07-09 Ahvaz University of Medical Sciences The effect of Melatonin in Schizophrenia treatment Investigating the effect of Melatonin on the cognitive symptoms of patients with Schizophrenia treated with Risperidone: a randomized double-blind clinical trial 2023-06-25 anticipated 66 Complete https://irct.ir/trial/70818 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, and in order to prevent the disclosure of the allocation in each group, the blinding method will be used. Patients are included in the study in order of referral. Patients will be distributed with a ratio of 1:1 and by 11 blocks (the length of each block is 6) (the sample size of this study is 66). The randomization sequence will be done using the randomization process method by Microsoft excel (Random between), Blinding description: In this study, patients will take medication packages predetermined by the study supervisor. The drug packages are completely similar in terms of shape and the patient and the project manager are not aware of their contents. In addition, the collection of information, assessment of patients and completion of forms are done by the project manager and his assistant, who are not aware of the contents of the medication packages used by patient. The data analysis stage will also be done by the project manager, and only the patient group (group 1 and 2) will be determined for data analysis. Therefore, this study plan would be double-blinded, and during patient allocation , data collection and information analysis contents of drugs packages would be hidden for all participants. 3 Schizophrenia. Intervention 1: Intervention group: In addition to the second-generation antipsychotic drug (risperidone) that they have already taken, the patients receive two 3 mg melatonin tablets at the same time (6 mg in total) for 6 weeks. Intervention 2: Control group: Patients receive a placebo tablet, which is similar to melatonin tablets (in terms of shape, smell, taste, size, and color) and starch powder with an approved color as needed made by the pharmaceutical laboratory of the Faculty of Pharmacy of Ahvaz 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 further information
public Behrouzian Forouzan
Psychiatry Dep,Golestan hospital, Farvardin Ave , Golestan Blvd
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3038 behrouzian-f@ajums.ac.ir Ahvaz University of Medical Sciences scientific Behrouzian Forouzan
Department of Psychiatry, Goleston Hospital, Farvardin Ave,Golestan Blvd
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3391 3963 behrouzian -f@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients admitted in the Psychiatric department of Ahvaz Golestan Hospital, who are in the age range of 16 to 65 years Diagnosis of schizophrenia based on DSM-5 criteria Informed consent of the patients or their guardian to participate in a research project Schizophrenic patients treated with risperidone 16 years 65 years Both Taking typical and atypical antipsychotic drugs, except for Risperidone, antidepressants, Sodium valproate, and Lithium. Presence of comorbid psychiatric disorder (bipolar-psychotic, obsessive-compulsive disorder, post-traumatic stress disorder, eating disorder) Current or past diagnosis (last 6 months) of severe personality disorders that compromise the participant's ability to meet the requirements. Use of narcotic drugs or alcohol in the last 12 months, except for nicotine and caffeine Presence of mental retardation or other neurological cognitive disorders such as dementia, delirium, head trauma, seizures, obstructive sleep apnea. History of ECT in the past 6 months In case of serious complications, the patient will be excluded from the study. Hypersensitivity to Melatonin or any of the ingredients in the placebo Use of Clozapine or previous use of Melatonin based on medical history obtained Pregnancy , lactating women Diagnosing the depressive episode of schizophrenia based on the Calgary questionnaire F20 Schizophrenia Treatment - Drugs Placebo Intervention group: In addition to the second-generation antipsychotic drug (risperidone) that they have already taken, the patients receive two 3 mg melatonin tablets at the same time (6 mg in total) for 6 weeks. Control group: Patients receive a placebo tablet, which is similar to melatonin tablets (in terms of shape, smell, taste, size, and color) and starch powder with an approved color as needed made by the pharmaceutical laboratory of the Faculty of Pharmacy of Ahvaz University of Medical Sciences, for 6 weeks. Cognitive symptoms of schizophrenia. Timepoint: First, 4 and 6 weeks after the study. Method of measurement: Wechsler Memory Questionnaire, Cognitive impairment investigation via review of auditory verbal learning, Digit symbol substitution test, Fluency test. Sleep-wake disorders. Timepoint: First, 4 and 6 weeks after the start of the study. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Ahvaz University of Medical Sciences Approved 2023-06-18 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Psychiatry Dep, Golestan Hospital, Farvardin Ave ,Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)