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IRCT20190606043827N1 IRCT 2020-02-08 Kashan University of Medical Sciences Memantine effect on patients with schizophrenia Effects of Memantine on cognitive impairment in schizophrenic patients 2019-09-01 anticipated 50 Complete https://irct.ir/trial/40143 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: All patients aged 18-50 years with schizophrenia (according to DSM-IV criteria) admitted to Kargarinejad Psychiatric Hospital in Kashan who had been undergoing routine schizophrenia for at least 3 months were randomly selected. Sampling was done randomly until the sample size was completed and information was collected through interviews, observation, and questionnaires. Patients were randomly divided into two groups: A and B. Randomization was done by using a random number table. Regarding concealment, a random sequence was given to a person in this method and sampling was performed at one or more centers simultaneously. Based on the order of the participants' entry into the study, the researcher communicates with the relevant center and asks about the random assignment of the participant to a specific group. Communication methods include phone, SMS, fax, email, and more, Blinding description: This study was a double-blind clinical trial. Patients and staff are unaware of the drug and placebo dose. 1 Schizophrenia. Intervention 1: Intervention group: The group was treated with memantine 5 mg (Made in Iran and Tolid daru factory)daily for 3 months and dosed at a maximum of 20 mg daily. This dose was selected according to the effective dose for patients with dementia. Intervention 2: Control group: The second group was treated with placebo, which was similar in flavor, color and mode, for 3 months. Yes - There is a plan to make this available What will be shared: In this study, some of the data, such as medical information, can be shared. When: Start the access period 1 month after printing results To whom: scholars and students Conditions: All scholars and students are required to apply ethical principles to the use of paper data. Where to obtain: To the author responsible How to obtain: Request by email Comments:
public Seyed Ahmad Hosseini
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
Kashan Iran (Islamic Republic of) 87111111111 +98 31 5550 0111 hosseini-sah@Kaums.ac.ir Kashan University of Medical Sciences scientific Seyed Ahmad Hosseini
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
Kashan Iran (Islamic Republic of) 8711111111 +98 31 5550 0111 hosseini-sah@Kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Schizophrenia according to DSM-IV criteria Age 18 to 50 years Receiving common drugs for schizophrenia for at least 3 months before the start of the study (Patients within 3 months of the previous 3 month antipsychotic with a constant dose of 300 to 1000 mg of chlorpromazine (except for clozapine) and a fixed dose of anticholinergic drug of 4 to 8 mg TG Phenidyl) Mental Status Mini Test Score (MMSE) Between 18 and 24 18 years 50 years Both Dependence and drug addiction smoking History of trauma to the head History of seizure Severe liver and kidney function disorders Severe neurological disorders Depression Receiving drugs that affect cognitive symptoms F20 Schizophrenia Treatment - Drugs Treatment - Drugs Intervention group: The group was treated with memantine 5 mg (Made in Iran and Tolid daru factory)daily for 3 months and dosed at a maximum of 20 mg daily. This dose was selected according to the effective dose for patients with dementia. Control group: The second group was treated with placebo, which was similar in flavor, color and mode, for 3 months. Adult Wechsler Memory Test Score. Timepoint: Measurement of mean Wechsler Adult Memory Test score from baseline, 6th week and 12th week after drug and placebo study. Method of measurement: Adult Wechsler memory test. Grade Severity of Positive and Negative Symptoms of Schizophrenia. Timepoint: Measure the mean score of severity of positive and negative symptoms of schizophrenia from baseline, 6th week and 12th week after drug and placebo study. Method of measurement: Questionnaire on the severity of positive and negative symptoms of schizophrenia. Hamilton Depression Scale Score. Timepoint: Measurement of mean Hamilton Depression Rating Scale from baseline, 6th and 12th week after drug and placebo study. Method of measurement: Hamilton Depression Scale Questionnaire. Kashan University of Medical Sciences Approved 2019-08-26 Ethics committee of Kashan University of Medical Sciences Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan Kashan Isfehan Iran (Islamic Republic of)