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)
Determining and comparing the rate of depression, anxiety and quality of life before and after taking Doxepin and Escitalopram and placebo and comparing symptoms with the severity of chronic obstructive pulmonary disease (COPD).
Design
Two-blind clinical trial on 72 patients, randomized into two intervention groups and one placebo group
Settings and conduct
Vali-e-Asr Hospital, Internal ward and Clinic, 72 patients are randomly divided into two intervention groups and one placebo group، To blind the drugs, they are packaged and prepared in the form of uniform capsules by the supervisor, who provides them to the researcher. The researcher and the Data collector under study are both blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having any class of COPD with any severity, having symptoms of depression and anxiety.
Exclusion criteria: patients with any underlying disease other than chronic obstructive pulmonary disease and depression and anxiety, patients who have recently (two weeks from the start of the study)Have taken monoamine oxidase inhibitors or those taking these medications.
Intervention groups
The intervention group includes patients with chronic obstructive pulmonary disease receiving doxepin (25 mg/day) and citalopram (10 mg/day).
And the control group from the same patients who receive placebo capsules daily
Main outcome variables
anxiety and depression and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161023030452N2
Registration date:2021-06-04, 1400/03/14
Registration timing:registered_while_recruiting
Last update:2021-06-04, 1400/03/14
Update count:0
Registration date
2021-06-04, 1400/03/14
Registrant information
Name
Seyed abolfazl Ghoreishi
Name of organization / entity
Zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3342 0651
Email address
sabgho@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-10, 1400/02/20
Expected recruitment end date
2021-06-18, 1400/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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)
Public title
Evaluation of the effects of citalopram and doxepin in patients with chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Ethics, Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2020-12-15, 1399/09/25
Ethics committee reference number
IR.ZUMS.REC.1399.332
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes
2
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
3
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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
7
Description
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
8
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
3
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan University of Medical Sciences Valiasr Hospital
Full name of responsible person
Dr.S.A. Ghoreishi
Street address
Ark Str, Shahid Beheshti Hospital, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3354 4003
Email
sabgho@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. S.A. Ghoreishi
Street address
Zanjan University of medical Sciences, Azadi Sq, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3354 4003
Email
sabgho@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr.S.A. Ghoreishi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 33 3354 4001
Fax
Email
sabgho@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.S.A. Ghoreishi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 33 3354 4001
Fax
Email
sabgho@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.S.A. Ghoreishi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 33 3354 4001
Fax
Email
sabgho@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Medical students and doctors working in private centers
From where data/document is obtainable
Shahid Dr Beheshti Hospital, Zanjan University of Medical Sciences. Dr Seyed Abolfazl Goreishi
sabgho@zums.ac.ir
What processes are involved for a request to access data/document
After sending the email after review within a week
sabgho@zums.ac.ir