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IRCT20180421039376N1 IRCT 2018-05-05 Esfahan University of Medical Sciences Escitalopram efficacy on quality of life and prevention of depression in breast cancer patient with mastectomy Escitalopram efficacy on quality of life and prevention of depression in breast cancer patient with mastectomy 2018-04-26 anticipated 75 Complete https://irct.ir/trial/30788 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random number list, Blinding description: Double blind , the patients and the researcher. 3 Depression. Intervention 1: Intervention group: Escitalopram 10 mg tablets start once daily for the first 7 days, followed by increased dose 20 mg (two tablets) daily for the other 11 weeks. Depression and quality of life are measured respectively by DASS questionarrie and WHO questionarrie at the end of 4th, 8th, 12th week. Intervention 2: Control group: Placebo tablets similar to Escitalopram 10 mg tablets start once daily for the first 7 days ,followed by 2 tablets for the other 11 weeks. Depression and quality of life are measured respectively by DASS questionarrie and WHO questionarrie at the end of 4th, 8th, 12th week. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Zahra Zeinolabedini
Hezarjirib
Esfahan Iran (Islamic Republic of) 6581675653 +98 21 4484 1289 Z.zeinolabedini@hotmail.com Esfahan University of Medical Sciences scientific Zahra Zeinolabedini
Hezarjirib
Esfahan Iran (Islamic Republic of) 6581675653 +98 21 4484 1289 Z.zeinolabedini@hotmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Women 18-65 y/o Diagnosed with breast cancer stage I,II,IIIa and undergone modified radical mostectomy with or without chemothrapy and radiotherapy Consciously agreement Having at least literacy of writing and reading 18 years 65 years Female Pregnancy and lactation History of conductive heart diseases Severe renal failure Moderate to severe hepatic failure History of SSRI drugs reactions and sensitivity Suffering from depression mood disorders, bipolar disorders or psychotic disorders based on DSM V criteria Any condition limiting life expectancy Any Use of anti depression or anti anxiety drugs since 2 weeks before the study Any precipitation on group or individual psychotherapy sessions since 4 weeks before the study Suffering from any speech disorders Suffering from uncontrolled pain on the beginning of the study Having suicide plans or thoughts on the beginning of the study F06 Other mental disorders due to known physiological condition Treatment - Drugs Placebo Intervention group: Escitalopram 10 mg tablets start once daily for the first 7 days, followed by increased dose 20 mg (two tablets) daily for the other 11 weeks. Depression and quality of life are measured respectively by DASS questionarrie and WHO questionarrie at the end of 4th, 8th, 12th week. Control group: Placebo tablets similar to Escitalopram 10 mg tablets start once daily for the first 7 days ,followed by 2 tablets for the other 11 weeks. Depression and quality of life are measured respectively by DASS questionarrie and WHO questionarrie at the end of 4th, 8th, 12th week. Depression. Timepoint: 0-4-8-12 week. Method of measurement: DASS questionnaire. Esfahan University of Medical Sciences Approved 2017-02-08 Ethics committee of Isfahan University of Medical Science Hezarjirib Isfahan Isfehan Iran (Islamic Republic of)