Evaluation of efficacy and safety of duloxetine on mental status (anxiety / depression) of patients with diabetic neuropathy
Design
Clinical trial is performed on 30 patients by pre- and post-intervention method with one intervention group, non-corsaged, non-random, phase 2.
Settings and conduct
The study place is the office of supervisors and counselors (pain fellowship and endocrinologist), Specialist in the treatment of diabetic neuropathy and Evaluation of its effect and drug side effects on reducing depression and anxiety of patients for eligible patients (30 patients) prescribes duloxetine and He asks them to come back after 30 days of taking the medicine. The tool used to collect information is Beck Anxiety and Depression Inventory Which is completed by patients before and after the intervention. Also, side effects of the drug after the intervention and the amount of pain in patients are determined based on the VAS scale before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All diabetic patients aged 20 to 85 years with sensory diabetic neuropathy in the organs in which there are signs of anxiety or depression, referred to Dr. Rahmanian's office in 1401-1400.
Exclusion criteria: non-cooperation of the patient in taking the drug, intolerance of the drug by the patient, pregnant women.
Intervention groups
We have only one intervention group That a specialist doctor to treat diabetic neuropathy and Investigating its effect on reducing depression and Anxiety of patients for them duloxetine in the form of 30 mg oral capsulesIt is prescribed twice a day (once every 12 hours) and should be consumed for up to 30 days.
Main outcome variables
Mental status (anxiety / depression) of patients based on Beck questionnaire and drug side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210725051977N2
Registration date:2022-04-07, 1401/01/18
Registration timing:prospective
Last update:2022-04-07, 1401/01/18
Update count:0
Registration date
2022-04-07, 1401/01/18
Registrant information
Name
Masoud Khoshbin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3726 9893
Email address
masoudkhoshbin@iauyazd.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of duloxetine on the mental state of patients with diabetic neuropathy (anxiety / depression)
Public title
the effect of duloxetine on theanxiety and depression of patients with diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 85
Diabetic patients with sensory diabetic neuropathy in organs with symptoms of anxiety or depression (ASA patients 1-3)
Exclusion criteria:
Lack of patient cooperation in proper drug use or response
Drug intolerance by the patient
Pregnant women
Age
From 20 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ali Ibn Abi Talib Medical School (AS), Islamic Azad University, Yazd Branch
Street address
Safaieh, Alam Square, Boulevard of the Shohadaie Gomnam, Ali Ibn Abitaleb Medical School
City
Yazd
Province
Yazd
Postal code
8915813135
Approval date
2022-02-28, 1400/12/09
Ethics committee reference number
IR.IAU.YAZD.REC.1400.063
Health conditions studied
1
Description of health condition studied
Effect of Duloxetine on the Mental State of Patients (Anxiety) with Diabetic Neuropathy
ICD-10 code
E08.43
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy
2
Description of health condition studied
Effect of Duloxetine on the Mental State of Patients (Depression) with Diabetic Neuropathy
ICD-10 code
E08.43
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy
Primary outcomes
1
Description
Determination mental state (anxiety / depression) of patients with diabetic neuropathy based on Beck questionnaire
Timepoint
Determining the score of anxiety and depression at the beginning of the study (before the intervention) and 30 days after taking duloxetine
Method of measurement
Beck Anxiety and Depression Inventory questionnaire
Secondary outcomes
1
Description
Intensity of pain Fingers or toes based on VAS scale
Timepoint
Determining the score of anxiety and depression at the beginning of the study (before the intervention) and 30 days after taking Duloxetine
Method of measurement
Visual Analogue Scale
2
Description
Frequency of adverse drug complications (Duloxetine)
Timepoint
30 days after taking Duloxetine
Method of measurement
Check list including possible adverse drug reactions following Duloxetine
Intervention groups
1
Description
Intervention group: A group treated with duloxetine in the form of 30 mg oral capsules,Twice a day (every 12 hours) for 30 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Personal office of Dr Masoud Khoshbin - Pain fellow
Full name of responsible person
Dr Masoud Khoshbin
Street address
40th dead end, in front of Sepah, Shahid Sadoughi Boulevard, Yazd- Iran
City
Yazd
Province
Yazd
Postal code
8917694784
Phone
+98 35 3138 0155
Fax
+98 35 3138 0155
Email
masoudkhoshbin@iauyazd.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ahmad Shajari
Street address
Safaieh, Alam Square, Ali Ibn Abitaleb Medical School
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 0540
Email
a_shajari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Dr Masoud Khoshbin
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yazd, Shahid Sadoughi Boulevard, in front of Sepah, 40th dead end
City
Yazd
Province
Yazd
Postal code
8917694784
Phone
+98 35 3138 0155
Fax
+98 35 3138 0155
Email
masoudkhoshbin@iauyazd.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Masoud Khoshbin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yazd, Shahid Sadoughi Boulevard, in front of Sepah, 40th dead end
City
Yazd
Province
Yazd
Postal code
8917694784
Phone
+98 35 3138 0155
Fax
+98 35 3138 0155
Email
masoudkhoshbin@iauyazd.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nahid Ghorbani
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 173, Aran Apartment, Jam Jam One St., Safir Omid Square, Shahid Ghandi Blvd., Yazd.
City
Yazd
Province
Yazd
Postal code
8949199777
Phone
+98 35 3828 5368
Email
Nahid.ghorbani1995@gmail.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
En There is 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