therapeutic efficacy of bupropion on sexual arousal and desire disorder in female patient with multiple sclerosis
Design
60 married female patient with MS diagnosis and sexual arousal and desire disorder according to DSM-V, enter the study.the patients are divided in to 2 group as case and control according to randomized block.
Settings and conduct
60 patients who are visited in Kashani hospital of Isfahan enter the study after receiving informed consent.drug and placebo are given to patients in identical package.patients and the person who follow up them have no information about the drug type.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1-ability to read and write
2-age between 18-50
3-have a contraception method and no plan for pregnancy during intervention
4-a marital relationship for at least six months, not considering divorce or separation, and alternately having sex with her husband
5-diagnosis of sexual arousal and desire disorder according to FSFI criteria
exclusion criteria:
1-her husband has a sexual disorder
2-active psychiatric illness (except depression)
3- having sexual pain disorder,sexual identity disorder and paraphilia simultaneously
4-menopause
5-primary or secondary infertility
6-history of seizure or head injury
7-alcohol or substance abuse in previous year
8-taking psychiatric drugs or any medication which affect sexual function
9-recieving concomitant psychological intervention
Intervention groups
the trial group receive bupropion with maximum dose of 300 mg per day and control group receive an identical placebo.
Main outcome variables
sexual function,intimacy and sexual function,fatigue,depression,sexual desire,sexual arousal,vaginal lubrication,orgasm,sexual satisfaction,pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120302009188N2
Registration date:2020-02-15, 1398/11/26
Registration timing:registered_while_recruiting
Last update:2020-02-15, 1398/11/26
Update count:0
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
Majid Barekatain
Name of organization / entity
Isfahan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2475
Email address
barekatain@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-21, 1398/07/29
Expected recruitment end date
2020-02-18, 1398/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
bupropion efficacy on sexual arousal and interest among female patient suffering multiple sclerosis
Public title
bupropion therapy in multiple sclerosis patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ability to read and write
age between 18-50 year old
use of a contraception method and no planning for pregnancy
being in sexual relation for at least 6 months and do not think about divorce or separation and have sexual intercourse with her partner routinely
diagnosis of sexual arousal and interest disorder according to FSFI
Exclusion criteria:
having a partner with sexual disorder
suffering from an acute psychiatric disorder (with the exception of depression)
having sexual pain disorder(disparunia or vaginismus),gender identity disorder, paraphilia
menopause
having primary or secondary infertility
history of convulsion or head injury
substance or alcohol abuse in previous year
taking psychiatric drug or any medication which affect sexual function
receiving a psychotherapy simultaneously
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using a random number table for people with obsessive-compulsive disorder. The random numbers and numbers are extracted by the computer and for allocation concealment unique code will be used
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know the type of drug they are taking and the drug is given to them in separate packages and the shape and color of the drug are not recognizable. The person with whom he or she is affiliated as a health care provider will not be provided with information about the patient's drug use.
Placebo
Used
Assignment
Parallel
Other design features
the patients are divided in two groups of case and control according to block random allocation
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethic committee of Isfahan university of medical science
Street address
Behavioal science research center, noor hospital, ostandari street, isfahan, iran
City
Isfahan
Province
Isfehan
Postal code
8145831451
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
IR.MUI.MED.REC.1398.124
Health conditions studied
1
Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
sexual function rate in female sexual function index questionnaire
Timepoint
measurement of female sexual function index at the beginning of the study(before intervention) and 4,8 weeks after taking Bupropion
Method of measurement
female sexual function index questionnaire
Secondary outcomes
1
Description
fatigue severity
Timepoint
measurement of fatigue severity at the beginning of the study and 4,8 weeks after taking Bupropion
Method of measurement
fatigue severity scale
2
Description
beck depression scale
Timepoint
measurement of depression at the beginning of the study and 4,8 weeks after taking Bupropion
Method of measurement
beck depression inventory
Intervention groups
1
Description
Intervention group:bupropion tablets are formed in 2 dosage 75 and 150 mg.in this study therapy is started with 75 mg daily and according to patient response to the drug the dosage will be increased weekly to the maximum dosage of 150 mg twice daily. therapy last for 2 months.
Category
Treatment - Drugs
2
Description
Control group: instead of bupropion, the patients receive placebo.(tablets in same size,shape, color without effective substance, which will be delivered in paper bag) use instruction is the same as intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
kashani hospital
Full name of responsible person
majid barekatain
Street address
Behavioal science research center, noor hospital, ostandari street, isfahan, iran
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2475
Email
barekatain@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Shaghayegh haghdoost
Street address
hezar jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2273
Email
info@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Majid barekatain
Position
full professor of psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Ostandari street
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3222 2475
Email
barekatain@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid barekatain
Position
full professor of psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Ostandari Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3222 2475
Email
barekatain@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
majid barekatain
Position
full professor of psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral Sciences Research Center, Khorshid hospital
City
isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3222 2475
Email
barekatain@med.mui.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be available
When the data will become available and for how long
The start of the access time is immediately after the relevant article is publish.
To whom data/document is available
All people can access the data.
Under which criteria data/document could be used
All analyzes needed can be done on data, and all individuals can apply for data
From where data/document is obtainable
Applicants can contact the phone number 09173877382 to receive the data
What processes are involved for a request to access data/document
The data will be available to the applicant as soon as possible