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IRCT20201201049553N1 IRCT 2021-07-08 Tehran University of Medical Sciences Deputy of Research and Technology Effect of Pregabalin in Behavioral and psychological symptoms of dementia(BPSD) Evaluating the effect of Pregabalin in treatment of Behavioral and psychological symptoms of dementia(BPSD) 2021-07-23 anticipated 58 Complete https://irct.ir/trial/52750 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling takes place when a patient is referred to the neurology clinic of Roozbeh Hospital, and the patient meets the study's inclusion and exclusion criteria. For sampling allocation, permuted block randomization technique is used to prepare a randomizing table. Regarding the fact that patients divide in two groups with 1:1 allocation ratio (29 patients in control group and 29 patients in treatment group), the block size is 4, the patients will be divided into blocks of 4 and will receive medication or placebo (A or B), for assigning blocks we use random number generation. A random number will be generated for each treatment assignment and the permutation will be determined based on the numbers assigned from the greatest to the smallest number. To avoid having a block size of 2, we will have 13 blocks with the size 4 and a block of size 6, Blinding description: Blinding is carried out by a clinical pharmacist with a randomizing table. The medications are given to the investigator with a specified code. Neither the consulting physician nor the investigator have any any information on the coding process. Placebos are 100 percent identical both in appearance and in number to the medication itself. 3 ‌Behavioral and psychological symptoms of dementia (BPSD). Intervention 1: Intervention group: Patients in this group receive Pregabalin with the initial dose 50mg per day, the dose increases every week to the maximum of 150 mg twice a day for 12 weeks. Both Pregabalin Tablets and placebos are manufactured by Sobhan Darou Pharmaceutical company. Intervention 2: Control group: Patients in this group are given placebo once a day for the first week and then twice a day for 12 weeks. placebos are the exact physical replica of Levetiracetam tablets manufactured by Sobhan Darou Pharmaceutics. All the excipients are chemically the same and only the API (Active Pharmaceutical Ingredient) is removed. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Leyla maleki
School of Pharmacy, Tehran University of Medical Sciences, 16 Azar Street, Enghelab, Tehran
tehran Iran (Islamic Republic of) 1417614411 +98 21 2269 2781 l-maleki@student.tums.ac.ir Tehran University of Medical Sciences scientific Niayesh Mohebbi
School of Pharmacy, Tehran University of Medical Sciences, 16 Azar Street, Enghelab Avenue, Tehran
Tehran Iran (Islamic Republic of) 1417614411 0098 21 64120 nmohebbi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with dementia of the following types: Alzheimer's, vascular dementia or mixed vascular dementia, based on DSM V criteria Patients with moderate to severe dementia based on the result of diagnostic tools such as FAST or MoCA no limit no limit Both Other types of dementia such as Lewy body or frontotemporal dementia History of major psychological disorders History of drug abuse History of epilepsy or other neurological disorders such as Multiple Sclerosis or head concussion which may exacerbate behavioral symptoms F03.91 Unspecified dementia with behavioral disturbance Treatment - Drugs Placebo Intervention group: Patients in this group receive Pregabalin with the initial dose 50mg per day, the dose increases every week to the maximum of 150 mg twice a day for 12 weeks. Both Pregabalin Tablets and placebos are manufactured by Sobhan Darou Pharmaceutical company. Control group: Patients in this group are given placebo once a day for the first week and then twice a day for 12 weeks. placebos are the exact physical replica of Levetiracetam tablets manufactured by Sobhan Darou Pharmaceutics. All the excipients are chemically the same and only the API (Active Pharmaceutical Ingredient) is removed Sum of score for Behavioural Pathology in Alzheimer's Disease questionnaire. Timepoint: Before Taking pregabalin, and 4,8,12 weeks after taking pregabalin. Method of measurement: Behavioural Pathology in Alzheimer's Disease questionnaire. Sum of score for Neuropsychiatric Inventory questionnaire. Timepoint: Before Taking pregabalin, and 4,8,12 weeks after taking pregabalin. Method of measurement: Neuropsychiatric Inventory (NPI) questionnaire. Sum of score of dementia quality of life questionnaire. Timepoint: Before taking Pregabalin and on the weeks of 4,8,12 after taking pregabalin. Method of measurement: dementia quality of life (qol) questionnaire. Tehran University of Medical Sciences Deputy of Research and Technology Approved 2021-01-19 Ethics committee The institute of pharmaceutical sciences- Tehran University Of medical Sciences-TIP Faculty of pharmacy, Tehran University of medical sciences, Poursina Av. Keshavaraz blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)