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IRCT20210613051565N1 IRCT 2021-07-19 University of social welfare and rehabilitation sciences "Effect of Mirtazapine on aggression in patients with Alzheimer" The effect of adding Mirtazapine to quetiapine on reducing aggression in patients with Alzheimer's dementia 2021-07-23 anticipated 52 Complete https://irct.ir/trial/56921 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Unit randomization happens in the form of blocks consisting of four units. For all six possible permutations, the numbers are associated as below: 1(AABB), 2(ABAB), 3(ABBA), 4(BBAA), 5(BABA), 6(BAAB) . Using a random table, numbers are chosen among those 6 groups to designate the allocated treatment. To continue the process of randomization, a hidden label method was adopted to further encode the blocks. In this method, blocks are numbered using a sequence of random numbers, then the randomly assigned treatment (medicine) is put in each block. The cans/blocks are then handed over to executive agents. Researcher allocates patients to either intervention or standard treatment based on the order of their arrival/reception. Tools: Create a randomized sequence using four random encoded blocks for the participants of the study. Approach: Random selection of the blocks and reading the letters from right to left on labelled blocks based on random sequence. Blocks are of the same weight and shape and prepared by an independent researcher, Blinding description: This clinical trial is blinded so that the participants, the clinician, , principle researcher ,data collector and outcome evaluator do not have any info about the assignment of individuals to the groups. The evaluation of the subjects is done by the external evaluator who is not involved in the research team. The main drug and placebo that are similar (in terms of odour, colour, shape and taste) are placed in similar cans having the same weight by a person who is not a member of the research team. Drugs are coded based on random sequence in two groups ( A) and (B) and they are numbred randomly. A unique code is assigned to each patient .The researcher provides the drug to the participant according to the coding. 3 Alzheimer's dementia. Intervention 1: Intervention group: Patients with entry criteria who have symptoms of agitation or aggression. These patients are treated with Quetiapine(Abidi company) and during 2-4 weeks, the dose of the drug is titrated according to the patient's tolerance and reaches 150-100 mg per day. The Cohen-Mansfield Agitation Inventory questionnaire is then completed for the patient (the patient will be used with the patient to complete information related to this questionnaire). Patients with a score of 45 or higher are randomly divided into intervention (A) and control (B) groups (patients with a score Under 45 are excluded from the study)Group A as the intervention group, in addition to quetiapine drug treatment, receive 15 mg of mirtazapine(Tadbir kala jam company) tablets at night, which will increase to 30 mg after two weeks (48) and will continue until the sixth week. Intervention 2: Control group: Group B as a control group, in addition to Quetiapine(Abidi) drug therapy, is given a placebo tablet(Abidi company), which will be one tablet a night for the first two weeks and two tablets a night after two weeks. The packaging and shape of the two tablets are similar to maintain the blinding of the study. The patients are followed up weekly for six weeks and are monitored by telephone visits for side effects, especially CNS and exacerbation of drowsiness, and patient admissions will be reviewed and excluded if a complication occurs. Psychiatric symptoms were recorded based on the (Cohen-Mansfield Agitation Inventory) scale as well as the severity and stage of dementia according to the( Mini–mental state examination) score at the beginning of the study, the end of the fourth week and the sixth week, and in the sixth week the data are statistically analysed. 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 I haven't decided.
public Sahar Darvishskandari
Unit 3, No 14, Omidvar Ave., Hidarie St., Zargandeh
Tehran Iran (Islamic Republic of) 1916994695 +98 21 2200 7927 saharskandari1975@gmail.com University of social welfare and rehabilitation sciences scientific Sahar Darvishskandari
Unit 3, No 14, Omidvar Ave., Heidari St., Zargandeh
Tehran Iran (Islamic Republic of) 1916994695 +98 21 2200 7927 saharskandari1975@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Adult patients (over the age of 18) With Alzheimer's dementia At least two years have passed since the onset of the disease Confirm by a neurologist or psychiatrist with the NIA-AA (2011 National Institute on Aging and Alzheimer's Association) diagnostic criteria assistant. Participant's consent Cohen-Mansfield Agitation Inventory (CMAI) test score more than 45 18 years no limit Both No psychiatric disability No physical disability No neurological disability Any disease with significant cognitive Impairment, (mental retardation) No substance abuse in the previous six months No extra psychiatric medication G30 Alzheimer's disease Treatment - Drugs Treatment - Drugs Intervention group: Patients with entry criteria who have symptoms of agitation or aggression. These patients are treated with Quetiapine(Abidi company) and during 2-4 weeks, the dose of the drug is titrated according to the patient's tolerance and reaches 150-100 mg per day. The Cohen-Mansfield Agitation Inventory questionnaire is then completed for the patient (the patient will be used with the patient to complete information related to this questionnaire). Patients with a score of 45 or higher are randomly divided into intervention (A) and control (B) groups (patients with a score Under 45 are excluded from the study)Group A as the intervention group, in addition to quetiapine drug treatment, receive 15 mg of mirtazapine(Tadbir kala jam company) tablets at night, which will increase to 30 mg after two weeks (48) and will continue until the sixth week. Control group: Group B as a control group, in addition to Quetiapine(Abidi) drug therapy, is given a placebo tablet(Abidi company), which will be one tablet a night for the first two weeks and two tablets a night after two weeks. The packaging and shape of the two tablets are similar to maintain the blinding of the study. The patients are followed up weekly for six weeks and are monitored by telephone visits for side effects, especially CNS and exacerbation of drowsiness, and patient admissions will be reviewed and excluded if a complication occurs. Psychiatric symptoms were recorded based on the (Cohen-Mansfield Agitation Inventory) scale as well as the severity and stage of dementia according to the( Mini–mental state examination) score at the beginning of the study, the end of the fourth week and the sixth week, and in the sixth week the data are statistically analysed. -Cognitive changes by the MMSE - symptoms of agitation and aggression by the CMAI. Timepoint: In 0,4,6 weeks. Method of measurement: Questionnaire Mini–mental state examination(MMSE) ,Questionnaire Cohen Mansfield Agitation Inventory(CMAI). University of social welfare and rehabilitation sciences Approved 2021-06-13 University of Social Welfare and Rehabilitation Sciences Unit 3 ,No.14,Omidvar Ave.,Haidari St, Zargandeh , Tehran, Iran Tehran Tehran Iran (Islamic Republic of)