Escitalopram efficacy on quality of life and prevention of depression in breast cancer patients with mastectomy
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment in patients with mastectomy in Isfahan university of medical science heamatology and onchology hospitals
Participants/Inclusion and exclusion criteria
Women 18-65 y/o
Intervention groups
Escitalopram and placebo group
Main outcome variables
Depression score ; anxityscore ; quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180421039376N1
Registration date:2018-05-05, 1397/02/15
Registration timing:registered_while_recruiting
Last update:2018-05-05, 1397/02/15
Update count:0
Registration date
2018-05-05, 1397/02/15
Registrant information
Name
Zahra Zeinolabedini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4484 1289
Email address
z.zeinolabedini@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-26, 1397/02/06
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Escitalopram efficacy on quality of life and prevention of depression in breast cancer patient with mastectomy
Public title
Escitalopram efficacy on quality of life and prevention of depression in breast cancer patient with mastectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Random number list
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind , the patients and the researcher
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
Hezarjirib
City
Isfahan
Province
Isfehan
Postal code
6581675653
Approval date
2017-02-08, 1395/11/20
Ethics committee reference number
Ir.mui.rec.1395.3.637
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F06
ICD-10 code description
Other mental disorders due to known physiological condition
Primary outcomes
1
Description
Depression
Timepoint
0-4-8-12 week
Method of measurement
DASS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyedoshohada Hospital of Heamatology and onchology
Full name of responsible person
Zahra Zeinolabedini
Street address
Hezarjirib
City
Isfahan
Province
Isfehan
Postal code
۶۵۸۱۶۷۵۶۵۳
Phone
+98 31 3792 8091
Email
Z.zeinolabedini@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoy Javanmard
Street address
Hezarjirib
City
Isfahan
Province
Isfehan
Postal code
6581675653
Phone
+98 31 3792 8091
Email
Z.zeinolabedini@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Zeinolabedini
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezarjirib
City
Esfahan
Province
Isfehan
Postal code
6581675653
Phone
+98 21 4484 1289
Fax
Email
Z.zeinolabedini@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Zeinolabedini
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezarjirib
City
Esfahan
Province
Isfehan
Postal code
6581675653
Phone
+98 21 4484 1289
Fax
Email
Z.zeinolabedini@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Zeinolabedini
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezarjirib
City
Esfahan
Province
Isfehan
Postal code
6581675653
Phone
+98 21 4484 1289
Fax
Email
Z.zeinolabedini@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available