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Comparison of the effect of duloxetine with nortriptyline on depression, anxiety, and quality of life in patients with functional dyspepsia

Protocol summary

Study aim
Comparing the effect of duloxetine with nortriptyline on depression, anxiety, and quality of life in patients with functional dyspepsia
Design
46 patients are initially evaluated by the desired questionnaires. Then, based on the table of random numbers, they are placed in one of groups A (Duloxetine) or B (Nortriptyline). They are re-evaluated after three months. The test work is in phase 4
Settings and conduct
Patients referred to the GI clinic of Taleghani Hospital are included in the study. At the beginning ,it is measured using Nepin's quality of life questionnaire and Hamilton's depression and anxiety questionnaires. Group A volunteers are treated with duloxetine at a dose of 20 to 30 mg daily for 3 months, and group B receives 10 to 20 mg nortriptyline daily. Score of quality of life, anxiety and depression based on Nepin and Hamilton questionnaires at the end of the first month, the end of the second month, and the end of the third month after the start of the survey by an interviewer who does not know which medicine the patient is taking received, are evaluated.
Participants/Inclusion and exclusion criteria
inclusion criteria: age 18 -70 years, education diploma, willingness to cooperate in the project, and not having an allergy to duloxetine and nortriptyline. Exclusion criteria: suffering from any type of serious psychiatric illness or other gastrointestinal disease, taking antidepressants or antipsychotic drugs in the last 6 weeks, not fully answering the questionnaires, not cooperating in the follow-ups, causing severe side effects of the drug used. pregnancy or breastfeeding, desire to leave the project
Intervention groups
Patients with functional dyspepsia are divided into two groups. Duloxetine will be prescribed for the first group and nortriptyline for the second group.
Main outcome variables
Improving the level of anxiety, depression, quality of life and disease symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220329054367N2
Registration date: 2022-11-06, 1401/08/15
Registration timing: registered_while_recruiting

Last update: 2022-11-06, 1401/08/15
Update count: 0
Registration date
2022-11-06, 1401/08/15
Registrant information
Name
Seyed Shahab Banihashem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2540
Email address
shb_banihashem@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of duloxetine with nortriptyline on depression, anxiety, and quality of life in patients with functional dyspepsia
Public title
Comparison of the effect of psychiatric drugs on the improvement of psychological symptoms and disease severity in patients with functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with functional dyspepsia based on ROME-IV Having a diploma education Willingness to cooperate in the project Not having an allergy to Deloxetine and Nortriptyline
Exclusion criteria:
Having any type of serious psychiatric illness (severe anxiety or depression, psychosis, bipolar disorder, anorexia or bulimia nervosa) Having any other gastrointestinal disease except functional dyspepsia Taking antidepressants or antipsychotics in the last 6 weeks Failure to complete the questionnaires Non-cooperation in follow-ups causing severe side effects of the drug used (Deloxetine or Nortriptyline) Pregnancy or breastfeeding during the study period
Age
From 18 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to two arms, using block randomization method. The block size is four, involving 3 patients (based on order’s coming) which would generated by online block randomization software “Sealed Envelope”. The list of random blocks will be placed in envelopes, daily would be opened by the staffs.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are evaluated at the end of the first month, the end of the second month and the end of the third month after the start of the examination by an interviewer who does not know which medicine the patient received.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-07-14, 1400/04/23
Ethics committee reference number
IR.SBMU.MSP.REC.1400.176

Health conditions studied

1

Description of health condition studied
functional dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia

Primary outcomes

1

Description
anxiety
Timepoint
Measuring anxiety before the start of the study and one, two and three months after the start of the intervention
Method of measurement
Hamilton anxiety questionnaire

2

Description
depression
Timepoint
Measuring depression before the start of the study and one, two and three months after the start of the intervention
Method of measurement
Hamilton depression questionnaire

3

Description
quality of life
Timepoint
Measuring quality of life before the start of the study and one, two and three months after the start of the intervention
Method of measurement
Nippen questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first intervention group, 20 mg duloxetine (Cymbalta brand name) is prescribed for patients. Patients are advised to take the medicine with food. Patients should take this medicine for three months.
Category
Treatment - Drugs

2

Description
Intervention group: In the first intervention group, nortritiline drug with a dose of 25 mg (Aventyl brand name) is prescribed for the patients. Patients are advised to take the medicine with food. Patients should take this medicine for three months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Amir Sadeghi
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2540
Email
taleghanihospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Zali
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2525
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsa Mofateolshia
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2541
Email
mahsa.3652@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahab Banihashen
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2524
Email
shb_banihashem@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somayeh Motazedian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
009812243241
Email
somayehmotazedian@yahoo.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
Confidentiality of participants' data
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
Undecided - It is not yet known if there will be 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
The study protocol, statistical analysis map and study report will be available to those who request more information about the plan
When the data will become available and for how long
Since the publication of the article
To whom data/document is available
Researchers, research companies, students, professors
Under which criteria data/document could be used
In order to complete the information of a study and citing the reference
From where data/document is obtainable
To the authors of the project
What processes are involved for a request to access data/document
Sending a request email to the responsible author and mentioning the reason for the request and how to use the information
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