The effectiveness of drug holiday method on sexual function in women treated with selective serotonin reuptake inhibitors other than fluoxetine: a randomized clinical trial compared with control group
The effectiveness of drug holiday method on sexual function in women treated with selective serotonin reuptake inhibitors other than fluoxetine: a randomized clinical trial compared with control group
Design
In this two arm parallel group randomized trial, random allocation will be used based on balance block randomization and by 4:1 blocks
Settings and conduct
Female married patients in maintenance phase of treatment with a Selective Serotonin Reuptake Inhibitor and suffering from sexual side effect referred to outpatient psychiatric clinics of Iran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
18-50 years old female married patients live with their husbands, in maintenance phase of treatment with a SSRI and suffering from sexual side effect will be included. Patients with sexual dysfunction before starting the medication, substance dependence and taking another medication with established sexual side effect currently will be excluded
Intervention groups
Drug holiday group won`t use the SSRI in two days in every week. Control group continues the medication without any change in type and dosage of the medication
Main outcome variables
Sexual Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211027052886N1
Registration date:2022-03-07, 1400/12/16
Registration timing:registered_while_recruiting
Last update:2022-03-07, 1400/12/16
Update count:0
Registration date
2022-03-07, 1400/12/16
Registrant information
Name
shiva soraya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4452 5615
Email address
soraya.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2023-06-19, 1402/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of drug holiday method on sexual function in women treated with selective serotonin reuptake inhibitors other than fluoxetine: a randomized clinical trial compared with control group
Public title
Drug holiday method on sexual function in women treated with selective serotonin reuptake inhibitors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
woman Married lived with husband In maintenance phase of treatment with a SSRI Suffering from sexual side effect
Exclusion criteria:
Sexual dysfunction before starting the medication
substance dependence and taking another medication with established sexual side effect currently
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Entry to the study will be based on a block table of random numbers based on quadruple blocks, and each time a person enters the study, the evaluator and his / her importer will be unaware of what group the next person will be in. At any time, during contact with another researcher who has a table of numbers, he will be informed about his entry into the control group or intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences,Next to Milad Tower, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-10-22, 1400/07/30
Ethics committee reference number
IR.IUMS.FMD.REC.1400.417
Health conditions studied
1
Description of health condition studied
Sexual side effect with SSRIs
ICD-10 code
F19.981
ICD-10 code description
Other psychoactive substance use, unspecified with psychoactive substance-induced sexual dysfunction
Primary outcomes
1
Description
Sexual function
Timepoint
Weeks: 0, 4, 8
Method of measurement
Female Sexual Health Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 25 female and married patients undergoing maintenance phase of standard care with one of the selective serotonin reuptake inhibitors, except fluoxetine , enter the study and intervention is that the patient does not take medication for eight weeks on Tuesdays and Fridays. Also, the mental health assessment of patients will be performed on the basis of questionnaire 28 public health questions (GHQ - 28)in the first two turns and the end of the study. The authentication and monitoring of sexual performance is performed by the women's sexual performance index (FSFI). This assessment is a pre - intervention before intervention for all participants, and then they are told to answer all questions of the questionnaire after 4 and then 8 weeks after the study.to increase the degree of participation of participants and higher accuracy of information, every week by the researcher is called on by the researcher and is followed and followed by the pattern of the medication holiday, the incidence of duty, and the fulfillment of the questionnaire
Category
Treatment - Other
2
Description
Control group: 25 female and married patients undergoing maintenance phase of standard care with one of the selective serotonin reuptake inhibitors, except fluoxetine, are studied in the group of control and continue the drug without altering the type and dose of medicine. Also, the mental health assessment of patients will be performed on the basis of questionnaire 28 public health questions (GHQ - 28)in the first two turns and the end of the study. The authentication and monitoring of sexual performance is performed by the women's sexual performance index (FSFI). This assessment is a pre - intervention before intervention for all participants, and then they are told to answer all questions of the questionnaire after 4 and then 8 weeks after the study.to increase the degree of participation of participants and higher accuracy of information, every week by the researcher is called on by the researcher and is followed and followed by the pattern of the medication holiday, the incidence of duty, and the fulfillment of the questionnaire