Protocol summary

Study aim
Evaluating the effect of Lactofem supplementation on sexual function of men with depression compared to antidepressant treatment alone
Design
The clinical trial has a control group, with parallel groups, randomized, phase 3 on 120 patients with depression treated with antidepressants. The random assignment sequence will be determined using the computer program "Computer Random Generation".
Settings and conduct
This research will be conducted on 120 patients with depression treated with anti-depressants in Shahid Muftah Clinic, Yasuj . Patients will be divided into two intervention groups (receive lactofem supplement in addition to antidepressants) and control (take antidepressants alone).
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18-45 years; Reading and writing literacy; scoring less than 20 and diagnosing mild to moderate depression on the Hamilton scale; being treated for at least 4 weeks with antidepressants that affect sexual function; Married; having sex at least once a month; having an emotionally satisfying relationship with a stable and sexually active partner for at least one year. Exclusion criteria: sexual problems before taking antidepressants; symptoms of psychosis; loss of relatives, acquaintances or friends during the last six months; known sexual problem in women
Intervention groups
Intervention group: Antidepressant drug plus one Lactofem capsule was administered daily for three months. Control group: Antidepressant drug alone.
Main outcome variables
Sexual function, Depression severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160524028038N20
Registration date: 2024-05-17, 1403/02/28
Registration timing: prospective

Last update: 2024-05-17, 1403/02/28
Update count: 0
Registration date
2024-05-17, 1403/02/28
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
bazarganipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-19, 1403/02/30
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Lactofem supplementation on sexual function of men with depression compared to antidepressant treatment alone
Public title
Lactofem and sexual function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-45 years Reading and writing literacy Obtaining a score of less than twenty and diagnosing mild to moderate depression on the Hamilton scale For at least 4 weeks, be treated with anti-depressants that affect sexual function Marriage Having sex at least once a month Having an emotionally satisfying relationship with a stable and sexually active spouse for at least one year Desire to participation
Exclusion criteria:
The unwillingness of the research unit during sampling, which will lead to his withdrawal from the study Having speech or hearing problems Addiction to drugs and alcohol in a person or his partner Sexual problem before taking antidepressants symptoms of psychosis Loss of relatives, acquaintances or friends during the last six months Known sexual problem in women Suffering from internal diseases such as cardiovascular, thyroid, arthritis, diabetes, epilepsy, kidney infection Taking drugs that affect sexual performance, such as blood pressure reducers, antihistamine H2 blockers, barbiturates)
Age
From 18 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using Random Allocation Software (RAS) in such a way that the number of groups and the size of the sample are written in the specified part, and by clicking the generate random list option, each sample is given a code in which group is placed. Allocation concealment is sequentially numbered, opaque, sealed envelopes (SNOSE).
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 Yasuj University of Medical Sciences
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, kohgiluyeh and boyer-ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.YUMS.REC.1402.189

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
Sexual function
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Male sexual function Questionnaire

2

Description
Depression severity
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Beck depression questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Selective serotonin reuptake inhibitor (SSRI) antidepressant Escitalopram (10mg, daily) plus one Lactofem capsule (including Lactobacillus acidophilus 109 ، 2, Bifidobacterium bifidus 109 ، 2, Lactobacillus rutri 2 × 109, Lactobacillus fermentum 109 × 2; capsule weight of 500 mg bio-capsule) made by Iranian zist-takhmir Company was administered daily for 3 months orally.
Category
Treatment - Drugs

2

Description
Control group: Taking selective serotonin reuptake inhibitor (SSRI) antidepressant alone.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yasuj University of medical sciences, Shahid Mofateh Clinic
Full name of responsible person
Fatemeh Bazarganipour
Street address
Yasuj University of medical sciences, Shahid Mofateh Clinic, Motahari Bulvard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
f.bazarganipour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amin Hosseini
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
amin.hosseini@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Bazarganipour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Yasuj University of medical sciences, Shahid Mofateh Clinic, Motahari Bulvard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 912 425 8623
Email
f.bazarganipour@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Bazarganipour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Yasuj University of medical sciences, Shahid Mofateh Clinic, Motahari Bulvard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 912 425 8623
Email
f.bazarganipour@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Bazarganipour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Yasuj University of medical sciences, Shahid Mofateh Clinic, Motahari Bulvard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 912 425 8623
Email
f.bazarganipour@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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