This randomized clinical trial will be conducted to assess the effectiveness of escitalopram on pain, anxiety and depression of newly diagnosed breast cancer patients in Babol.
Design
In this clinical trial with control group, 40 newly diagnosed breast cancer patients with symptoms of depression and anxiety who do not have the exclusion criteria, will be allocated randomly in two groups of case and control.
Settings and conduct
In this study, 40 new breast cancer patients in the hospitals of Babol, who are referred to the study surgeon for mastectomy will be enrolled.
Patients in the intervention group will be treated with escitalopram for 4 weeks and the control group will receive placebo during this period. The patients at the beginning of the study (before surgery) and 4 weeks after surgery will be evaluated for pain severity, depression and anxiety.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Newly diagnosed breast cancer patients who have anxiety and depression symptoms based on Hospital Anxiety and Depression Scale
Exclusion criteria: The history of high mood, suicidal thoughts, mental retardation, dementia and substance dependence
Intervention groups
Intervention group: 10 milligram per day escitalopram capsule manufactured in Abidi Pharmaceutical Company for four weeks
Control group: one placebo capsule containing starch for four weeks
Effect of escitalopram on pain, anxiety and depression in patients with breast cancer
Public title
Escitalopram in breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Newly diagnosed breast cancer patients
With depression and anxiety symptoms
Exclusion criteria:
Previous history of high mood
Suicidal thoughts
Mental retardation
Dementia
Substance dependence
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The distribution of patients in the two treatment groups is conducted by block random allocation method. The free website of www.randomization.com is used to generate the allocation sequence. The resulting sequence is written in separate sheets and placed in sealed envelopes and is provided to the main investigator for the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients do not know about the type of drug or placebo which they receive.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafrooz avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4136747176
Approval date
2018-10-06, 1397/07/14
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.152
Health conditions studied
1
Description of health condition studied
Malignant neoplasm of breast
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Pain severity
Timepoint
At the beginning of the study and four weeks after intervention
Method of measurement
Visual Analogue Scale
2
Description
Depressive symptoms
Timepoint
At the beginning of the study and four weeks after intervention
Method of measurement
Hospital Anxiety and Depression Scale
3
Description
Anxiety symptoms
Timepoint
At the beginning of the study and four weeks after intervention
Method of measurement
Hospital Anxiety and Depression Scale
Secondary outcomes
1
Description
Escitalopram- related side effects
Timepoint
In four weeks of intervention period
Method of measurement
Medical visit
Intervention groups
1
Description
Intervention group: 10 milligram per day escitalopram capsule manufactured in Abidi Pharmaceutical Company for four weeks
Category
Treatment - Drugs
2
Description
Control group: One placebo capsule containing starch for four weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Novin Nikbakhsh
Street address
Shahid Sargord Ghassemi avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 2071
Email
novinsu@hotmail.com
2
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Novin Nikbakhsh
Street address
Ganjafrooz avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4718747415
Phone
+98 11 3223 8264
Email
novinsu@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi, MD, PhD
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
4136747176
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Sussan Moudi, MD
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Shahid Yahyanejad Hospital, Babol
City
Babol
Province
Mazandaran
Postal code
4718747415
Phone
+98 11323268823
Fax
Email
sussan.mouodi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sussan Moudi, MD
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Shahid Yahyanejad Hospital, Babol
City
Babol
Province
Mazandaran
Postal code
4718747415
Phone
+98 11323268823
Fax
Email
sussan.mouodi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sussan Moudi, MD
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Shahid Yahyanejad Hospital, Babol
City
Babol
Province
Mazandaran
Postal code
4718747415
Phone
+98 11323268823
Fax
Email
sussan.mouodi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some of the data, such as information related to the primary and secondary outcomes, can be shared.
When the data will become available and for how long
The information related to the primary and secondary outcomes can be shared after publication of the final study report.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
In order to conduct similar studies in human populations, if a request email is received by the academic researchers, the requested information will be provided to them.
From where data/document is obtainable
Sussan Moudi, Psychiatrist, Associate Professor of Babol University of Medical Sciences
What processes are involved for a request to access data/document
The request email from the academic researchers should be sent to sussan.mouodi@gmail.com. Within 3 weeks after receipt of the email, the requested information will be sent by email.