Evaluating the effects of treatmen with amitriptyline as a tricyclic antidepressant drug on serum prolactin levels in patients with chronic migraine and its relation with patient’s quality of life and function
Evaluating the effects of treatmen with amitriptyline as a tricyclic antidepressant drug on serum prolactin levels in patients with chronic migraine and its relation with patient’s quality of life and function
Design
cases in pilot study consist of 20 patients and they will be evaluated in a before- after manner
Settings and conduct
study will be conducted on kosar hospital of semnan patients.general information about patients and also their quality of life as well as their serum prolactin levels will be gathered
Participants/Inclusion and exclusion criteria
inclusion:patients with chronic migraine with or without typic aura
exclusion:hyperprolactinoma,hypothalamus-hypophysis diseases,recent head or chest trauma,kidney or hepatic failure,PCOD,menestrual irregularity or menopause,depression or anxiety,anorexia,thyroid problems,convulsive disorders,pregnancy,taking anti-depressants or anti-psychotics,heart conditions,glaucoma or any contraindication to TCAs in patients
Intervention groups
in this study we evaluate serum prolactin levels as well as life quality in patients with migraine who need preservative treatment before starting and 2 month after treatment with amitriptyline and we analyze the changes and their relation to each other
Main outcome variables
evaluation of the effects of serum prolactin changes in response to treatment with amitriptyline on patients quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211013052758N1
Registration date:2021-11-03, 1400/08/12
Registration timing:registered_while_recruiting
Last update:2021-11-03, 1400/08/12
Update count:0
Registration date
2021-11-03, 1400/08/12
Registrant information
Name
negar emadeddin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8867 1907
Email address
negaremadi.92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-02, 1400/08/11
Expected recruitment end date
2022-11-02, 1401/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of treatmen with amitriptyline as a tricyclic antidepressant drug on serum prolactin levels in patients with chronic migraine and its relation with patient’s quality of life and function
Public title
Evaluating the effects of treatmen with amitriptyline as a tricyclic antidepressant drug on serum prolactin levels in patients with chronic migraine and its relation with patient’s quality of life and function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with migraine without aura who need preservative treatment
patients with migraine with classic aura who need preservative treatment
Exclusion criteria:
anything that might affect serum prolactin levels in patients including medications or comorbidities
contraindications of TCAs prescription such as heart disease or anaphylaxia
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
evaluation of serum prolactin levels and also patients quality of life based on a standard questanier
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
5th floor , No.5 - 19th st. , Gandhi st. , Tehran , Tehran
City
Semnan
Province
Semnan
Postal code
1517865433
Approval date
2021-10-31, 1400/08/09
Ethics committee reference number
IR.SEMUMS.REC.1400.186
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
effects of amytriptyline induced serum prolactin level changes on migraine patients quality of life
Timepoint
before starting treatment and 2 month after starting treatment with amitriptyline
Method of measurement
prolactin serum level test (ELISA) - Headache impact test (HIT) questionier
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:patients with migraine with typic aura or without aura
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital of Semnan
Full name of responsible person
Negar Emadeddin
Street address
5th floor, No. 5 , 19th st. , Gandhi st. , Tehran , Tehran
City
Semnan
Province
Semnan
Postal code
1517865433
Phone
+98 21 8867 1907
Email
negaremadi.92@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Negar Emadeddin
Street address
5th floor, No. 5 , 19th st. , Gandhi st. , Tehran , Tehran
City
semnan
Province
Semnan
Postal code
1517865433
Phone
+98 21 8867 1907
Email
negaremadi.92@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
60
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
Semnan University of Medical Sciences
Full name of responsible person
Negar Emadeddin
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
5th floor, No. 5 , 19th st. , Gandhi st. , Tehran , Tehran
City
Tehran
Province
Tehran
Postal code
1517865433
Phone
+98 21 8867 1907
Email
negaremadi.92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Negar Emadeddin
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
5th floor, No. 5 , 19th st. , Gandhi st. , Tehran , Tehran
City
Tehran
Province
Tehran
Postal code
1517865433
Phone
+98 21 8867 1907
Email
negaremadi.92@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Negar emadeddin
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
5th floor , No.5 - 19th st. , Gandhi st. , Tehran , Tehran
City
Tehran
Province
Tehran
Postal code
1517865433
Phone
+98 21 8867 1907
Email
negaremadi.92@gmail.com
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
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
data include patients general data as demographic data also information about patients history and treatments they take as well as the results of patients serum prolactin test and quality of life.
When the data will become available and for how long
accessibility 12 month after publish of the results
To whom data/document is available
researchers and industries
Under which criteria data/document could be used
any usage of data and/or information relating to this study should first be confirmed by people conducting this study
From where data/document is obtainable
any request can be sent via mail to
negaremadi.92@gmail.com
or asked by visiting Semnan university of medical science
What processes are involved for a request to access data/document
sending request
filling permission forms
waiting to respond