The effectiveness of drug holiday method on sexual function in men 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 men 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
Male married patients in maintenance phase of treatment with a SSRI 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 male married patients live with their wife, 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
SSRIs
IRCT registration information
IRCT registration number:IRCT20170123032145N6
Registration date:2021-10-25, 1400/08/03
Registration timing:prospective
Last update:2021-10-25, 1400/08/03
Update count:0
Registration date
2021-10-25, 1400/08/03
Registrant information
Name
Mohammadreza Shalbafan
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1665
Email address
shalbafan.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2023-03-20, 1401/12/29
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 men 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 men treated with selective serotonin reuptake inhibitors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married lived with wife
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
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be used in this trial based on balance block randomization and by 4:1 blocks
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, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-05-16, 1400/02/26
Ethics committee reference number
IR.IUMS.FMD.REC.1400.130
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
Male Sexual Health Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Drug holiday group won`t use the SSRI in two days in every week.
Category
Treatment - Other
2
Description
Control group: Control group continues the medication without any change in type and dosage of the medication.