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IRCT20161023030452N2 IRCT 2021-06-04 Zanjan University of Medical Sciences Evaluation of the effects of citalopram and doxepin in patients with chronic obstructive pulmonary disease Evaluation of the effects of Escitalopram and Doxepin on improving anxiety and depression and quality of life in patients with chronic obstructive pulmonary disease (COPD) 2021-05-10 anticipated 72 Complete https://irct.ir/trial/54684 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, block randomization will be used to assign to study groups. In this method, blocks of 6 sizes are created, then enough blocks are selected to reach the required sample size in each group. Individual randomization unit is a random number table randomization tool. This type of random assignment will cause the ratio in each of the studied groups to be almost equal at any time of the research. As it is known, 12 blocks of 6 will be created and finally, 24 samples will be placed in 3 groups, Blinding description: In In this study, the researcher and data collector did not know which drugs or placebo were. Only the main person in charge of the study (the supervisor) knows about the drug or placebo, and due to the fact that the form of the drugs is different, before starting the study, all the drugs are packaged in the same capsules by the supervisor and Provides to the researcher (resident). 3 Condition 1: Depression. Condition 2: Anxiety. Condition 3: Chronic obstructive pulmonary disease. Intervention 1: Intervention group: Doxepin 25 mg of the tricyclic antidepressant drug is given as a capsule from Sobhan Pharmaceutical Company once a day for two months to 24 patients with chronic obstructive pulmonary disease. Intervention 2: Intervention group: Escitalopram 10 mg of antidepressant drug serotonin reuptake inhibitors is given as a capsule from Sobhan Pharmaceutical Company once a day for two months to 24 patients with chronic obstructive pulmonary disease. Intervention 3: Intervention group: The ready-made placebo is given as a capsule from Sobhan Pharmaceutical Company once a day for two months to 24 patients with chronic obstructive pulmonary disease. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Medical students and doctors working in private centers Where to obtain: Shahid Dr Beheshti Hospital, Zanjan University of Medical Sciences. Dr Seyed Abolfazl Goreishi sabgho@zums.ac.ir How to obtain: After sending the email after review within a week sabgho@zums.ac.ir Comments:
public Dr.S.A. Ghoreishi
Shahid Beheshti Hospital
Zanjan Iran (Islamic Republic of) 4515613191 +98 33 3354 4001 sabgho@zums.ac.ir Zanjan University of Medical Sciences scientific Dr.S.A. Ghoreishi
Shahid Beheshti Hospital
Zanjan Iran (Islamic Republic of) 4515613191 +98 33 3354 4001 sabgho@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Age over 40 years Having any class of COPD with any severity Having symptoms of depression and anxiety Patients with stable COPD so that their disease status does not change from day to day and are under constant treatment and there is no change in the type of treatment 40 years no limit Both Those whose illness has worsened recently (one week from the start of the study) or while studying Patients with severe dementia, severe cognitive impairment, end-stage cancer, and mental illness, including schizophrenia, suicidal ideation, and more Patients who have recently (two weeks after the start of the study) taken monoamine oxidase inhibitors or those who are taking these medications Patients whose ECG shows long QT intervals Pregnant or lactating women Patients with severe liver, kidney, cardiovascular and motor diseases Patients with uncontrollable epilepsy Patients with a history of intolerance to antidepressants F32.8 F06.4 J44 Other depressive episodes Anxiety disorder due to known physiological condition Other chronic obstructive pulmonary disease Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Doxepin 25 mg of the tricyclic antidepressant drug is given as a capsule from Sobhan Pharmaceutical Company once a day for two months to 24 patients with chronic obstructive pulmonary disease. Intervention group: Escitalopram 10 mg of antidepressant drug serotonin reuptake inhibitors is given as a capsule from Sobhan Pharmaceutical Company once a day for two months to 24 patients with chronic obstructive pulmonary disease. Intervention group: The ready-made placebo is given as a capsule from Sobhan Pharmaceutical Company once a day for two months to 24 patients with chronic obstructive pulmonary disease. Depression score in the questionnaire. Timepoint: Depression at the beginning of the study (before the intervention) 14 days 30 days and 60 days after the intervention. Method of measurement: DASS 21 Questionnaire. Anxiety score in the questionnaire. Timepoint: Anxiety at the beginning of the study (before the intervention) 14 days 30 days and 60 days after the intervention. Method of measurement: DASS 21 Questionnaire. Stress score in the questionnaire. Timepoint: Stress at the beginning of the study (before the intervention) 14 days 30 days and 60 days after the intervention. Method of measurement: DASS 21 Questionnaire. Physical health score in the questionnaire. Timepoint: Physical health score at the beginning of the study (before the intervention) 14 days 30 days and 60 days after the intervention. Method of measurement: WHOQOL-BREF questionnaire. Mental health score in the questionnaire. Timepoint: Mental health score at the beginning of the study (before the intervention) 14 days 30 days and 60 days after the intervention. Method of measurement: WHOQOL-BREF questionnaire. Social relations score in the questionnaire. Timepoint: Social relations score at the beginning of the study (before the intervention) 14 days 30 days and 60 days after the intervention. Method of measurement: WHOQOL-BREF questionnaire. Environmental health score. Timepoint: Environmental health score at the beginning of the study (before the intervention) 14 days 30 days and 60 days after the intervention. Method of measurement: WHOQOL-BREF questionnaire. General health score (quality of life). Timepoint: General health score (quality of life) at the beginning of the study (before the intervention) 14 days 30 days and 60 days after the intervention. Method of measurement: WHOQOL-BREF questionnaire. Zanjan University of Medical Sciences Approved 2020-12-15 Committee of Ethics, Zanjan University of Medical Sciences Zanjan University of Medical Sciences, Azadi Square, Zanjan Zanjan Zanjan Iran (Islamic Republic of)