Farnia et al Dovepress Assessed for eligibility(n=127) Excluded (n=59) Not meeting inclusion criteria(n=31) Refused to participate before further assessments(n=12) Excluded according exclusion criteria(n=16) Randomized(n=68) Rosa damascena Placebo group (n=33) group (n=35) Received allocated Received allocated intervention(n=33) intervention(n=35) 号 Erratic use of medication Erratic use of placebo and ollO and discontinued intervention discontinued intervention before 8 weeks(n=5) before 8 weeks(n=3) Analyzed(n=30) Analyzed(n=30) Figure I CONSORT diagram showing the flow of participants through each stage. Abbreviations:n,number of subjects;CONSORT.Consolidated Standards of Reporting Trials experiencing sexual dysfunction after starting the SSRI A male patient was included in the study if the fol- regimen were included,trained professional psychiatrists lowing criteria were met:1)he was suffering from an performed interviews based on the structured clinical inter- MDD that was diagnosed by a psychiatrist and was view for psychiatric disorders(Mini International Neurop- based on the DSM-5 criteria;62 2)he was suffering from sychiatric Interview).51 Eligible patients(number [n]=127) SSRI-I SD according to the DSM-5;3)he scored at least were fully informed about the study aims and procedure 19 points or more on the self-rated depressive symptoms and about the confidential nature of data selection and data on the Beck Depression Inventory(BDI)and could thus be handling,and all of the patients gave their written informed diagnosed with moderate major depression;4)he scored consent.At that time,all eligible patients were in an acute 2 points or less for self-rated sexual dysfunction,as assessed depressive state according to the Diagnostic and Statistical via the Brief Sexual Function Inventory(BSFD);63 5)he had Manual of Mental Disorders,fifth edition (DSM-5)criteria.2 continuous pharmacological treatment with SSRIs for at Prior to being enrolled in the present study,patients had been least 6 weeks prior to entering the study;and 6)he signed a treated with and stabilized on an SSRI(standard medica- written informed consent form. tion)for at least 6 weeks.The treatment regimen remained Subjects were excluded if they met any of these criteria: unaltered throughout the 8-week duration of the study. 1)the subject did not meet the inclusion criteria as described 628 Neuropsychiatric Disease and Treatment 2015:II DovepressNeuropsychiatric Disease and Treatment 2015:11 submit your manuscript | www.dovepress.com Dovepress Dovepress 628 Farnia et al ([FOXGHGQ  1RWPHHWLQJLQFOXVLRQFULWHULDQ  5HIXVHGWRSDUWLFLSDWHEHIRUH IXUWKHUDVVHVVPHQWVQ  ([FOXGHGDFFRUGLQJH[FOXVLRQ FULWHULDQ  5DQGRPL]HGQ  5RVDGDPDVFHQD JURXSQ  5HFHLYHGDOORFDWHG LQWHUYHQWLRQQ  $OORFDWLRQ $VVHVVHGIRUHOLJLELOLW\Q  3ODFHERJURXSQ  5HFHLYHGDOORFDWHG LQWHUYHQWLRQQ  )ROORZXS (QUROOPHQW (UUDWLFXVHRIPHGLFDWLRQ DQGGLVFRQWLQXHGLQWHUYHQWLRQ EHIRUHZHHNVQ  (UUDWLFXVHRISODFHER DQG GLVFRQWLQXHGLQWHUYHQWLRQ EHIRUHZHHNVQ  $QDO\VLV $QDO\]HGQ  $QDO\]HGQ  Figure 1 CONSORT diagram showing the flow of participants through each stage. Abbreviations: n, number of subjects; CONSORT, Consolidated Standards of Reporting Trials. experiencing sexual dysfunction after starting the SSRI regimen were included, trained professional psychiatrists performed interviews based on the structured clinical inter￾view for psychiatric disorders (Mini International Neurop￾sychiatric Interview).61 Eligible patients (number [n]=127) were fully informed about the study aims and procedure and about the confidential nature of data selection and data handling, and all of the patients gave their written informed consent. At that time, all eligible patients were in an acute depressive state according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria.62 Prior to being enrolled in the present study, patients had been treated with and stabilized on an SSRI (standard medica￾tion) for at least 6 weeks. The treatment regimen remained unaltered throughout the 8-week duration of the study. A male patient was included in the study if the fol￾lowing criteria were met: 1) he was suffering from an MDD that was diagnosed by a psychiatrist and was based on the DSM-5 criteria;62 2) he was suffering from SSRI-I SD according to the DSM-5; 3) he scored at least 19 points or more on the self-rated depressive symptoms on the Beck Depression Inventory (BDI) and could thus be diagnosed with moderate major depression; 4) he scored 2 points or less for self-rated sexual dysfunction, as assessed via the Brief Sexual Function Inventory (BSFI);63 5) he had continuous pharmacological treatment with SSRIs for at least 6 weeks prior to entering the study; and 6) he signed a written informed consent form. Subjects were excluded if they met any of these criteria: 1) the subject did not meet the inclusion criteria as described