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IRCT20210425051075N1 IRCT 2021-10-15 Sabzevar University of Medical Sciences Effect of Mirtazapine on the quality of life of the breast cancer patients Evaluation of the effect of Mirtazapine on the quality of life of the breast cancer patients 2021-05-21 anticipated 110 Complete https://irct.ir/trial/55844 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: By easy sampling method, people who refer to the Chemotherapy and Radiotherapy Center who are eligible are randomly divided into two groups of intervention and control after selecting the sample. In this study, individuals were divided into two groups using permutation block method. In this method, A represents the individual receiving the intervention and B represents the individual in the control group. Considering the quadruple block; We give AABB code 0, ABAB code 1, ABBA code 2, BAAB code 3, BBAA code 4 and BABA code 5. Then, using a table of random numbers, we randomly selected the starting point. Considering the order of the numbers in the table, we place the permutation corresponding to each number we encounter. Therefore, by selecting the numbers from the table, the method of assigning a total of 110 people to the two groups will be determined, Blinding description: In this study, participants in the blind plan had no knowledge of any other treatment other than routine cancer treatment. 3 Condition 1: breast cancer. Condition 2: Major depressive disorder. Intervention 1: Intervention group: Patients will be treated with Mirtazapine 15-30 mg daily for 8 weeks. Intervention 2: Control group: Continuation of routine therapeutic care and no additional therapeutic intervention. Yes - There is a plan to make this available What will be shared: All data can be shared after making people unidentifiable When: 6 months after printing the results To whom: Can be used by all researchers Conditions: There are no restrictions for other researchers Where to obtain: Daniel Kamrani Email danialkamrani96@gmail.com Mobile 05138655892 Address: Sayad Shirazi St., No. 21 How to obtain: The applicant will send his / her application by email to the relevant researcher by mentioning the title of his / her research and the necessary information will be sent to him / her within a maximum period of 1 month. Comments:
public Danial Kamrani
No 48; Sayad-e-Shirazi blvd 21
Mashhad Iran (Islamic Republic of) 9179986981 +98 51 3865 5892 danialkamrani96@gmail.com Sabzevar University of Medical Sciences scientific Houman Kamranian
No.17, Motahhari 11 street
Sabzevar Iran (Islamic Republic of) 9414974877 +98 51 4465 1037 drkamranian@yahoo.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Suffering from cancer Major depressive disorder according to DSM IV criteria no limit no limit Both Taking sleeping pills at the same time c50 F32 Malignant neoplasm of breast Major depressive disorder, single episode Treatment - Drugs N/A Intervention group: Patients will be treated with Mirtazapine 15-30 mg daily for 8 weeks Control group: Continuation of routine therapeutic care and no additional therapeutic intervention Quality of Life. Timepoint: Study first and 8 weeks after starting mirtazapine. Method of measurement: WHO Quality of Life Questionnaire. Anxiety. Timepoint: Study first and 8 weeks after starting mirtazapine. Method of measurement: WHO Quality of Life Questionnaire. Sleep status. Timepoint: Study first and 8 weeks after starting mirtazapine. Method of measurement: WHO Quality of Life Questionnaire. Appetite status. Timepoint: Study first and 8 weeks after starting mirtazapine. Method of measurement: WHO Quality of Life Questionnaire. Sabzevar University of Medical Sciences Approved 2021-03-08 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences; Shohadaye-Hasteiy blvd Sabzevar Razavi Khorasan Iran (Islamic Republic of)