Comparison of two bupropion releasing agents and ritalin in reducing sexual dysfunction in women aged 20-45 years Candidate treatment with sertraline
Design
This is a one-way blind clinical trial.Two randomized groups of 25 patients are prescribed separately for each group.In each visit, the Arizona questionnaire is filled up by the researcher for the patient
Settings and conduct
Clinic of Yahyanejad and Rouhani hospitals who are candidates for psychiatric diagnosis receive one of the SSRIs (Sertralin) and according to the Arizona questionnaire there is no sexual dysfunction for them.
Participants/Inclusion and exclusion criteria
Women aged 20 to 45 years, according to psychiatric diagnosis, are candidates for one of the SSRIs (sertralin), and according to the Arizona questionnaire, they have no sexual dysfunction.
The men were excluded from these exclusion criteria: history of any previous sexual dysfunction over the last 6 months Major depression, drug users and cigarettes or herbal medicines for the treatment of sexual dysfunction, the development of chronic illnesses that are being treated, such as diabetes, Liver or kidney disease, cardiovascular disease (through interviews), and those who do not adhere to the protocol were excluded.
Intervention groups
25 female patients aged 20 to 45 years undergoing bupropion medication with sertraline treated with sexual dysfunction
25 female patients aged 20 to 45 years undergoing ritaline medication with sertraline treated with sexual dysfunction
Main outcome variables
Sexual dysfunction
General information
Reason for update
Acronym
.
IRCT registration information
IRCT registration number:IRCT20170606034348N2
Registration date:2018-09-19, 1397/06/28
Registration timing:retrospective
Last update:2018-09-19, 1397/06/28
Update count:0
Registration date
2018-09-19, 1397/06/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 121 3171
Email address
a.hamidia@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Efficacy of Bupropion and Ritaline on women Sexual Dysfunction Induced by serteralin)
Public title
the Efficacy of Bupropion and Ritaline
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patient aged 20 to 45 years undergoing treatment with sertraline
Exclusion criteria:
History of any previous sexual dysfunction
Consumers of any drugs and cigarettes or herbal medicines
Previous chronic diseas
Age
From 20 years old to 45 years old
Gender
Female
Phase
1-2
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were selected by convenience sampling method. 50 eligible participants were randomly divided into two groups of Bupropion treatment and Ritaline treatment. A randomized trial was conducted using binary random blocks. More precisely, accidental collisions were arranged Patients were enrolled in a pre-designed list that was randomly prescribed for one patient (Bupropion or Ritalin), so that the prescriber was not informed about the prescription drug (unilateral blindness).
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher will fill out the questionnaire on each visit, without any kind of medication
Placebo
Not used
Assignment
Parallel
Other design features
.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Babol University Of Medical Science
Street address
Yahya Nejad Hospital Ave
City
Babol
Province
Mazandaran
Postal code
4713566547
Approval date
2018-01-20, 1396/10/30
Ethics committee reference number
MUBABOL.HRI.REC.1396.165
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Score of sexual dysfunction in Arizona Sexual Experiences Scale questionnaire
Timepoint
.End of one month after treatment begins
Method of measurement
Arizona Sexual Experiences Scale is a short 5-point scale that evaluates sexual performance, especially sexuality, arousal, orgasm's ability to achieve orgasm during the next week. Arizona Sexual Experiences Scale, a tool for assessing sexual misconduct due to side effects of drug interventions in patients with depression or anxiety disorder, is filled by a person in charge of the research.
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group 1": In female patients aged 20 to 45 years with sertraline treatment that has been associated with sexual dysfunction during treatment with this drug, Ritalin tablet (methylphenidate) from Novartis Pharmaceutical company at a dose of 5 mg one hour before sex (PRN) It is prescribed for one month.
Category
Placebo
2
Description
"Intervention group 2": Female patients aged 20 to 45 years with sertraline treatment who have had a sexual dysfunction during the treatment; the Bupropion (wellban) tablet from the َAbidi Pharmaceutical Company at a dose of 150 mg daily (evening) for one month is prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahyanejad Hospital And Rohani Hospital
Full name of responsible person
Haghpanah Fahimeh
Street address
Emam khomeini Ave
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3229 1951
Email
fahimeh.haghpanah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Angela Hamidia
Street address
Blv Keshavarz
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 9596
Email
a.hamidia@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for research and technology, Babol 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
Babol University of Medical Sciences
Full name of responsible person
Angela Hamidia
Position
Asssistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Khomeyni Ave, Yahyanejad Hospital
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 9596
Email
a.hamidia@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Angela Hamida
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Khomeyni Ave- Yahyanejad Hospital
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3129 9596
Email
a.hamidia@mubbaol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Angela Hamidia
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Yayanejad Hospital Ave
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3229 1951
Email
a.hamidia@mubabol.ac.ir
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
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