Changes In Sexual Functioning Questionnaire Research Articles

Factors Affecting Sexual Function and Body Image of Early-Stage Breast Cancer Survivors in Poland: A Short-Term Observation

IntroductionKnowing the important factors influencing sexual function and body image might facilitate the recovery process of breast cancer survivors. Surgery type, relationship quality, and partner support might be modified to create a space for psychosexual intervention. Patients and MethodsThis retrospective questionnaire-based study was performed on 128 women aged 18 to 65 years who were free of disease at time of study entry and who underwent surgical treatment for breast cancer. Diagnostic and Statistical Manual of Mental Disorders criteria were used to assessed female sexual dysfunction (FSD). Changes in Sexual Functioning Questionnaire (CSFQ) were used to measure sexual function, whereas the Body Image After Breast Cancer Questionnaire (BIBCQ) was used to assess body image. The support of the partner was evaluated by the Provisions of Social Relation Scale (PSRS). ResultsThe median age of the studied respondents was 52.5 ± 10.1 years. FSD was diagnosed in 27.3% women. Lower physical satisfaction in relationship (odds ratio [OR] = 2.3), undergoing mastectomy (OR = 4.1) higher level of anxiety (OR = 4.2), and shorter duration of relationship (OR = 1.1) as well as not receiving adjuvant chemotherapy (F = 3.54), higher level of emotional satisfaction in relationship (F = 20.32), longer time after completion of oncologic treatment (F = 8.76), undergoing breast-conserving therapy (compared to mastectomy) (F = 13.21), and lower level of anxiety (F = 31,25) were important factors for the prevalence of FSD and positive body image, respectively. ConclusionType of surgery, time after completion of treatment, level of anxiety, adjuvant chemotherapy, partner support, and satisfying quality of relationship are important factors for sexual function, sexual quality of life, and body image in female breast cancer survivors.

S229. CAN LONG-ACTING INJECTABLE PALIPERIDONE DOSING BE OPTIMIZED WITH PLASMA LEVEL MEASUREMENTS?

BackgroundMost people with schizophrenia respond robustly to antipsychotic medication but are at very high risk of relapse if these medications are stopped. Long-term maintenance treatment with antipsychotic medication can dramatically reduce the risk of relapse. With long-acting injectable antipsychotic medication (LAI), adherence is documented which may account for superior efficacy in relapse prevention reported in some studies. It is known that plasma antipsychotic levels vary greatly across individuals with standard doses of LAIs. Establishing the lowest effective plasma levels for relapse prevention may also help in minimizing side effects that may contribute to problems with adherence. This study was carried out to describe the plasma paliperidone levels associated with clinical stability in patients receiving the LAI, paliperidone palmitate. We predicted that higher paliperidone plasma levels would be associated with lower subjective well-being and greater levels of sexual dysfunction.MethodsPatients with clinical diagnoses of schizophrenia and schizoaffective disorder attending specialized schizophrenia outpatient clinics at St. Joseph’s Healthcare Hamilton were invited to participate if they were receiving maintenance treatment with paliperidone palmitate. The study involved two visits, 3 to 4 weeks apart, on days that subjects were scheduled to receive consecutive injections of paliperidone palmitate. Plasma paliperidone levels and prolactin levels were drawn prior to the injection at Visit 1 and a second paliperidone levels was drawn at Visit 2. At Visit 1, a series of rating scales were also completed including the Subjective Well-being under Neuroleptic scale – Short version (SWN), the Changes in Sexual Functioning Questionnaire (CSFQ) and the Drug Attitude Inventory (DAI).ResultsTwenty-one subjects (11F/10M) provided informed consent for this study and had plasma paliperidone levels measured. Patients had been receiving LAI paliperidone for a mean of 18 months (SD = 11.4). Mean paliperidone levels at Visit 1 (n=21) and Visit 2 (n=18) were 34.9 ng/ml (SD = 20.0 ng/ml; range = 5.1–73.9 ng/ml) and 35.1 ng/ml (SD = 17.2 ng/ml; range = 9.0–67.5 ng/ml), respectively. Plasma paliperidone levels measured at Visit 2 were highly correlated with levels from Visit 1 (n=18; r = .89, p <.001). Plasma prolactin levels were correlated with levels of plasma paliperidone (n=21, r=0.56, p < .01). Lower scores on the CSFQ – Sexual Desire factor were associated with higher levels of paliperidone (n=19, r =-.61, p<.01) and prolactin (n=19, r=-.56, p <.01). Higher paliperidone levels were associated with more negative scores on the Drug Attitude Inventory (n=19, r=-0.49, p < .05). Plasma paliperidone levels were not associated with scores on the SWN (n=21, r=-.-02).DiscussionIn patients receiving maintenance treatment with paliperidone palmitate, plasma paliperidone levels varied approximately 15-fold. Higher paliperidone levels were associated with more negative attitudes towards medication and more severe deficits in sexual desire but not with subjective well-being. Many stable patients had plasma level close to the 20ng/ml level which in PET studies leads to 65% dopamine D2 receptor occupancy, a level reported to be associated with antipsychotic response. Our findings raise the possibility that maintaining patients at levels just above the 20ng/ml level may be sufficient for relapse prevention but may spare the adverse effects such as sexual dysfunction associated with higher plasma levels. These results suggest that measuring plasma levels in patients receiving paliperidone as a LAI may be of value in identifying the minimum effective dose for prevention of relapse and side effects.

Determinantes psicossociais do funcionamento sexual e bem‐estar sexual subjetivo em homens adultos portugueses

IntroductionSexual functioning and subjective sexual well‐being are very important human dimensions that contribute to the quality of life of men; however, there are no studies to report about normative measures for the Portuguese male population. PurposeTo assess the levels of sexual functioning and subjective well‐being in a sample of Portuguese adult men comparing differences between groups and determine the degree of association between the two variables. Materials and MethodsParticipants in the study were 603 adult men (mean age=42.05 years, standard deviation=13.93) who completed a sociodemographic questionnaire, the changes in sexual functioning questionnaire and the subjective sexual well‐being questionnaire. These measures disseminated over the internet. ResultsThe results obtained allowed us to produce a table of normative data for sexual functioning and subjective sexual well‐being, and statistically significant differences were found when comparing groups according to age, education, place of residence, number of children, marital status and their occupation. There was also a strong correlation between the two dimensions. Discussion and ConclusionsThis research allows us to highlight the importance of psychosocial determinants in the expression of sexual function and subjective sexual well‐being, to the extent that the health professionals who work with men in this area should be aware of how psychosocial contexts interfere with their sexual expression.

Sexual Functioning in Adolescents With Major Depressive Disorder.

To examine sexual functioning in adolescents with depression. Between September 2010 and March 2014, 235 participants who were between 15 and 20 years old and were unmedicated or within 1 month of beginning antidepressant treatment completed the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), and Changes in Sexual Functioning Questionnaire (CSFQ). They were also assessed to establish the presence of a DSM-IV-TR major depressive episode (MDE). The Student t test and χ² test were used to compare continuous and categorical variables, respectively, across participants with versus without MDE. Multivariable linear regression analysis examined the association between depression and sexual functioning. After the investigators controlled for age, female sex, antidepressant use, and the presence of generalized anxiety disorder, the presence of MDE was associated with a lower score on the CSFQ overall (P < .0007) and on its desire (P < .09), arousal (P < .001), and orgasm (P < .007) subscales. Antidepressants were not associated with sexual functioning either in the sample overall or in those with MDE. Beck Depression Inventory items related to affective symptoms (P < .03), rather than those tapping into neurovegetative or cognitive functioning, accounted for the association between depression and lower sexual functioning. Furthermore, with higher BDI scores, males exhibited a steeper decline than females in both the CSFQ total score and the desire subscale (sex × BDI score interaction effect: P < .03). Anxiety was not significantly associated with sexual functioning. Major depressive disorder in older adolescents is associated with lower sexual functioning, particularly in males. This appears most related to affective symptoms. The potential impact of such impairment on future sexual functioning deserves further examination. ClinicalTrials.gov identifier: NCT02147184.

Characterizing sexual function in patients with generalized anxiety disorder: a pooled analysis of three vilazodone studies.

BackgroundVilazodone has been shown to reduce core symptoms of generalized anxiety disorder (GAD) in three randomized, double-blind, placebo-controlled trials. Since sexual dysfunction (SD) is not well characterized in GAD, a post hoc analysis of these trials was conducted to evaluate the effects of vilazodone on sexual functioning in GAD patients.Materials and methodsData were pooled from one fixed-dose trial of vilazodone 20 and 40 mg/day (NCT01629966) and two flexible-dose studies of vilazodone 20–40 mg/day (NCT01766401, NCT01844115) in adults with GAD. Sexual functioning was assessed using the Changes in Sexual Functioning Questionnaire (CSFQ). Outcomes included mean change from baseline to end of treatment (EOT) in CSFQ total score and percentage of patients shifting from SD at baseline (CSFQ total score ≤47 for males, ≤41 for females) to normal functioning at EOT. Treatment-emergent adverse events related to sexual functioning were also analyzed.ResultsA total of 1,373 patients were included in the analyses. SD at baseline was more common in females (placebo, 46.4%; vilazodone, 49%) than in males (placebo, 35.1%; vilazodone, 40.9%). CSFQ total score improvement was found in both females (placebo, +1.2; vilazodone, +1.6) and males (placebo, +2.1; vilazodone, +1.0), with no statistically significant differences between treatment groups. The percentage of patients who shifted from SD at baseline to normal sexual functioning at EOT was higher in males (placebo, 40.6%; vilazodone, 35.7%) than in females (placebo, 24.9%; vilazodone, 34.9%); no statistical testing was performed. Except for erectile dysfunction and delayed ejaculation in vilazodone-treated males (2.4% and 2.1%, respectively), no treatment-emergent adverse events related to sexual functioning occurred in ≥2% of patients in either treatment group.ConclusionApproximately 35%–50% of patients in the vilazodone GAD studies had SD at baseline. Vilazodone and placebo had similar effects on CSFQ outcomes in both females and males, indicating a limited adverse impact on sexual functioning with vilazodone.

Lurasidone treatment of major depression with mixed features: Effect on sexual function

Introduction Sexual dysfunction is common in major depressive disorder (MDD), and frequently is worsened by antidepressant treatment. Objectives/aims To evaluate the effect of lurasidone on sexual functioning as measured by the Changes in Sexual Functioning Questionnaire (CSFQ) in patients with MDD with mixed features. Methods Patients meeting DSM-IV-TR criteria for MDD, who presented with 2 or 3 protocol-specified manic symptoms, were randomized to 6weeks of double-blind treatment with either lurasidone monotherapy 20–60mg/d ( n =109) or placebo ( n =100). Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total at week 6 was the primary efficacy endpoint, analyzed by MMRM. The CSFQ was assessed at baseline and week 6, analyzed by ANCOVA (LOCF). Results The mean CSFQ total scores at baseline were 36.5 and 34.1 in the lurasidone and placebo groups, respectively. Sexual function was rated as abnormal at baseline on the CSFQ by 77.8% of patients on lurasidone and 89.8% of patients on placebo. Treatment with lurasidone was associated with significant improvement in CSFQ total scores at week 6 (LOCF) compared with placebo (+5.1 vs. +3.1; P Conclusion Lurasidone treatment of MDD with mixed features was associated with significant improvement in sexual function.

THE VALIDATION OF CHANGES IN SEXUAL FUNCTION OF MALE ADDICTS QUESTIONNAIRE AND THE COMPARISON OF THEIR SEXUAL FUNCTION WITH HEALTHY PEOPLE

Objective: This study aimed to validate the scale of sexual function changes in male addicts. Methods: For this purpose, 101 male addicts who have used one or more types of drugswere selected from drug treatment centers in Semnan.A 14-item questionnaire (Vallejo et al., 2010) was used as a research instrument. Results : The data was analyzed by using exploratory factor analysis on SPSS. Three variables including sexual pleasure (mental factor), sexual desirewere estimated by Cronbach’s alpha 0. 90. Sexual arousal and orgasm (physical factor) was estimated by Cronbach's alpha 0.92. The correlation of changes of sexual function questionnaire with Hullbert index of sexual desire (HISD) and sexual desires questionnaire (DSI-2) was respectively significant at the levels of 0.79 and 0.77. This confirms the concurrent validity of our research instrument. Also the retest reliability for mentioned variables was respectively estimated as 0.95, 0.75, and 0.76. In comparison to non-addicted men, the questionnaire clearly showed the sexual dysfunction of addicted men which indicates its validity. Conclusions: So Changes in sexual function questionnaire is a validated tool which is appropriate for measuring changes in sexual function.

A Comparative Study of Post-traumatic Stress Disorder, Anxiety, Depression and Change in Sexual Functioning of Patients with Facial Injuries and Patients with Extremity Injuries.

This study was performed to identify and compare the presence of and the levels of post-traumatic stress disorder (PTSD), anxiety, depression and if any change in sexual functioning is present in patients with disfiguring facial injuries, nondisfiguring facial injuries and visible extremity injuries. A total of 378 patients from multi modal trauma centers in Bengaluru city were included for the study. A total of 153 patients were those who had disfiguring facial injuries, 111 patients with nondisfiguring facial injuries and 114 patients had sustained a visible extremity injury that was not covered by clothing (disfigurement /scarring). The assessments were carried out at three time intervals (the date of discharge, 1 month postoperatively and 6 months postoperatively) of the follow-up. The impact of events scale (IES), the hospital anxiety and depression scale (HADS) and changes in sexual functioning questionnaire (CSFQ) were used. Statistically significant higher means of IES, HADS (both for anxiety and depression) were present in patients with disfiguring facial injuries compared to patients with nondisfiguring facial injuries and visible extremity injuries and this was present at all three study intervals (date of discharge,1 st postoperative month and 6th postoperative month). There was a statistically significant change in the means of CSFQ scores of visible extremity injuries compared to other groups at the date of discharge bordering on sexual dysfunction, there was a raise in CSFQ scores among all three groups at the 1st postoperative month and the 6th postoperative month which was above the dysfunction cut-off. The results of this study led to the conclusion that in comparison with patients who had sustained disfiguring facial injuries, nondisfiguring facial injuries and visible extremity/ orthopedic injuries, the mean IES scores, HADS scores for both anxiety and depression of the facial disfiguring injury patients was higher at all three study intervals (date of discharge,1st postoperative month and 6 months postoperatively), indicating higher PTSD levels, anxiety and depression in patients with disfiguring facial injuries, CSFQ scores were above the cutoff suggested at the 1st month and 6th month postoperative indicating no sexual dysfunction in all the three groups.

Sexual dysfunctions in Tunisian patients with schizophrenia

Summary Introduction Sexuality in patients with schizophrenia is often overlooked. Very few studies examined sexual dysfunctions in such patients, especially in Tunisian socio-cultural context. The objective of this work was to assess sexual dysfunctions in Tunisian patients with schizophrenia. Methods A survey was conducted between August 8 and September 5, 2011 among consultants at departments of psychiatry “E” and “F” in Razi Mental Health Hospital in Mannouba, Tunisia. All consultants with schizophrenia, aged between 18 and 60, who were sexually active during the period of the study, were included. Sexual dysfunctions were assessed using the Changes in Sexual Functioning Questionnaire (CSFQ) translated to Arabic dialect. Results Thirty-eight patients were included. Sexual dysfunctions prevalence was 71% (n = 27) with no difference by sex. These figures are higher than those of the general population and are consistent with previous studies using the CSFQ. The average number of sexual dysfunctions was 3.8 per patient. There was no between-gender difference. The most frequent dysfunction was sexual pleasure dysfunction (50%; n = 19). The presence of sexual dysfunctions was significantly associated with early onset of schizophrenia, with high scores on the PANSS, with long acting antipsychotics, with high doses of antipsychotics, with the number of prescribed psychotropic medications and with good insight. Conclusions This study contributes to a better understanding of sexuality in patients with schizophrenia. Clinicians should consider sexual dysfunctions in these patients and discuss with them potential solutions to improve their quality of life and adherence to therapy.

Impact of human papillomavirus-related genital diseases on quality of life and psychosocial wellbeing: results of an observational, health-related quality of life study in the UK

BackgroundData on the psychosocial burden of human papillomavirus (HPV)-related diseases other than cervical cancer are scarce. The objectives of this study were to measure and compare the psychosocial burden and the impact on health-related quality of life (HRQoL) of HPV-related lower genital tract diseases and genital warts (GW) using several generic and disease-specific instruments.MethodsOverall, 842 individuals with normal cervical cytology (n = 241), borderline nuclear abnormalities and/or mild dyskaryosis (n = 23), cervical intraepithelial neoplasia (CIN)1 (n = 84), CIN2/3 (n = 203), vulval intraepithelial neoplasia (VIN)2/3 (n = 43), GW (n = 186) and a history of GW (non-current) (n = 62) were included. The generic European Quality of Life Index Version 5D (EQ-5D) questionnaire was completed by patients with GW and VIN2/3. Sexual functioning was evaluated using the Change in Sexual Functioning Questionnaire (CSFQ). Psychosocial impact was measured in women using the HPV Impact Profile (HIP) questionnaire. HRQoL was assessed using a GW-specific questionnaire, the Cuestionario Especifico en Condilomas Acuminados (CECA) (completed by patients with GW and history of GW). For each instrument, scores were compared between groups using the Student's t-test. In addition, utility loss due to GW and VIN2/3 was evaluated by comparing mean EQ-5D scores weighted by age and sex with the UK general population normal values.ResultsA significant psychosocial impact was found in women diagnosed with HPV-related genital diseases, particularly in those with GW. The health state of younger adults with GW was significantly impaired compared with UK normal values (mean EQ-5D index score 0.86 vs 0.94, p < 0.001 for 18–24-year-olds; 0.87 vs 0.93, p = 0.030 for 25–34-year-olds). VIN2/3 was found to have a significant negative impact on sexual functioning, and women with VIN2/3 had a highly impaired health state compared with women in the UK general population (weighted mean EQ-5D index score 0.72 vs 0.89, p < 0.001; weighted mean Visual Analogue Scale score 62 vs 85, p < 0.001).ConclusionsHPV-related lower genital tract lesions and GW significantly impair psychosocial wellbeing and HRQoL. The psychosocial aspects of HPV-related diseases need to be considered when evaluating the potential benefit of HPV vaccination.

Sexual functioning in patients with major depressive disorder in randomized placebo-controlled studies of extended release quetiapine fumarate

We evaluated sexual functioning from 6 acute, randomized, placebo-controlled studies (6-10 weeks) of once-daily extended release quetiapine fumarate (quetiapine XR) 50, 150, or 300 mg/day as monotherapy (Studies 1-4) or adjunct therapy (Studies 6-7) in major depressive disorder (MDD). We present a pre-planned, non-inferiority analysis of quetiapine XR monotherapy versus placebo using Changes in Sexual Functioning Questionnaire (CSFQ) total score change (Studies 1-4). Post hoc analyses evaluated CSFQ total and domain scores for fixed-dose monotherapy (Studies 1-2), modified fixed-dose (Studies 3-4), and adjunct therapy studies (Studies 6-7). CSFQ data for active comparators (duloxetine [Study 2], escitalopram [Study 4]) are reported. Quetiapine XR monotherapy was non-inferior to placebo for sexual functioning (least squares mean [LSM] difference in CSFQ score change versus placebo, 0.16 [95% confidence interval: -0.59, 0.92]); LSM change in CSFQ score: 1.90, quetiapine XR (all doses) and 1.73, placebo. LSM differences versus placebo (95% confidence interval): 0.18 (-1.40, 1.75), duloxetine (Study 2); 0.16 (-1.77, 2.10), escitalopram (Study 4). LSM differences with adjunct quetiapine XR 150 mg/day (0.52; p = 0.338) or 300 mg/day (0.22; p = 0.679) were comparable with placebo plus antidepressants. Post hoc all-patient and gender-specific analyses were comparable for CSFQ total scores versus placebo with quetiapine XR 50, 150, or 300 mg/day, duloxetine, and escitalopram. Discussion Lack of negative effects on sexual functioning in patients with MDD may improve treatment acceptability. Quetiapine XR (monotherapy or adjunct therapy) had an impact on sexual function that was comparable with placebo.

The Effect of Gepirone‐ER in the Treatment of Sexual Dysfunction in Depressed Men

Sexual dysfunction is common in patients with major depressive disorder (MDD). Antidepressant medications especially the selective serotonin reuptake inhibitors (SSRIs) may improve depressive symptoms but further decrease sexual function. Gepirone extended release (gepirone-ER) differs from the SSRIs in only affecting the 5-HT(1A) receptor and has demonstrated efficacy in treatment of depression and sexual dysfunction in depressed women. This report describes the effect of gepirone-ER on sexual function in depressed men. The aims of this article were to study the effects of gepirone-ER on sexual function in men with MDD and to determine if positive effects are independent of antidepressant or anxiolytic activity. The main outcome measures of this article were Hamilton depression rating scale (HAMD-17), and changes in sexual functioning questionnaire (CSFQ). In an 8-week study, gepirone-ER, placebo, or fluoxetine were administered in a double-blind fashion to 181 depressed men. The CSFQ results were used to determine quality of sexual function. To test for an antidepressant or anxiolytic effect, a 50% reduction in HAMD-17 score separated antidepressant responders from nonresponders, and item 12 of the HAMD scale (psychic anxiety) scores of 0 or 1 separated anxiolytic responders from nonresponders. Gepirone-ER treatment improved total sexual function compared with placebo measured by the CSFQ at weeks 4 (P=0.012) and 8 (P=0.046). At 4 weeks, almost every CSFQ domain is improved. The orgasm domain was especially improved, 67% by week 4. Gepirone-ER antidepressant and anxiolytic nonresponders showed significant improvement in sexual function. Fluoxetine treatment did not produce improvement. In fact, fluoxetine-treated subjects had lower scores on the total CSFQ, less than placebo, and significantly less than gepirone-ER. Gepirone-ER improves sexual dysfunction in depressed men. All domains of sexual function improved. Gepirone-ER has a pro-sexual effect independent of antidepressant or anxiolytic activity.

Sexual Functioning in Women and Men with Fibromyalgia

Sexual dysfunction has been associated with several chronic pain conditions, including fibromyalgia. However, the literature on sexual functioning in patients with fibromyalgia is limited and restricted to female patients. The aim of our study was to evaluate sexual functioning in female and male patients with fibromyalgia compared with healthy controls. Sexual functioning was evaluated using the Spanish validated version of the Changes in Sexual Functioning Questionnaire (CSFQ). We used baseline data from several studies performed in adult patients with fibromyalgia (American College of Rheumatology criteria) of both sexes in which sexual functioning was included in the clinical evaluation. As a control group, we selected an age-matched group of healthy subjects. We calculated the proportion of patients exhibiting sexual dysfunction (i.e., a CSFQ total score equal to or lower than 41 in females and 47 in males). CSFQ scores for patients and controls were compared, and the effect sizes for the difference of means were calculated. Our sample comprised 293 patients with fibromyalgia (276 females and 17 males) and 86 healthy controls (72 females and 14 males). The frequency of sexual dysfunction was significantly higher in patients with fibromyalgia than in controls for both females (86.9% vs. 23.6%; relative risk [RR] 3.7, 95% confidence interval [CI], 2.4-5.6) and males (76.5% vs. 6.7%; RR 11.5, 95% CI, 1.7-77.6). We found significantly worse sexual functioning for all dimensions in both female and male patients with fibromyalgia. Effect sizes for the difference in mean scores of the CSFQ were large overall and for all dimensions in both females and males. Our results show that sexual dysfunction is common in patients with fibromyalgia. The disease seems to deeply affect all dimensions of sexual functioning in both females and males.

Sexual Function in Women with Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is a common endocrinologic disorder. Little is known about the effects of PCOS on overall sexual functioning, phases of the sexual response cycle, and sexual satisfaction. To compare the differences in sexual function between women with PCOS and controls, and to assess the relationship of serum testosterone, body mass index (BMI), hirsutism, and acne with sexual function scores in women with PCOS. A cross-sectional analysis in which women who met the National Institute of Child Health and Human Development criteria for PCOS were compared with a group of healthy volunteers. Results from the validated Changes in Sexual Functioning Questionnaire (CSFQ) were used to assess sexual function. In women with PCOS, serum testosterone levels, BMI, self-reported hirsutism, and acne were assessed as independent variables. Ninety-two women with PCOS and 82 controls were studied. Based on total CSFQ scores, sexual dysfunction was present in 27.2% of cases vs. 24.4% of controls (not signifcant). Women with PCOS had a significantly lower orgasm/completion score compared with women in the control group (P < 0.001). Women with PCOS whose testosterone levels were >1 standard deviation above the mean had significantly better sexual functioning vs. those within 1 SD (P = 0.015) and those >1 SD below the mean (P = 0.033). In women with PCOS, increasing BMI was associated with a significant reduction in the orgasm/completion subdomain, but no significant associations were found in regard to acne or hirsutism. Women with PCOS have similar sexual functioning scores compared with controls except in regard to orgasm/completion. The subpopulation of women with PCOS whose serum testosterone levels are in the normal reproductive range are at increased risk for sexual dysfunction.

A Randomized, Double-Blind, Placebo-Controlled, 8-Week Study of Vilazodone, a Serotonergic Agent for the Treatment of Major Depressive Disorder

To evaluate the efficacy, and further establish the safety profile, of oral once-daily vilazodone, a potent and selective serotonin 1A receptor partial agonist and reuptake inhibitor, in the treatment of major depressive disorder (MDD). This phase 3, randomized, double-blind, placebo-controlled, 8-week study (conducted March 2008-February 2009) enrolled 481 adults with DSM-IV-TR-defined MDD. Patients received vilazodone (titrated to 40 mg/d) or placebo. The primary efficacy endpoint was change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to end of treatment. Secondary efficacy measures included MADRS and 17-item Hamilton Depression Rating Scale (HDRS-17) response and change in HDRS-17, HDRS-21, Hamilton Anxiety Rating Scale (HARS), Clinical Global Impressions-Severity of Illness (CGI-S), and Clinical Global Impressions-Improvement (CGI-I) scores. The Changes in Sexual Functioning Questionnaire (CSFQ) was administered at baseline and week 8. Vilazodone-treated patients had significantly greater improvement (P = .009) according to the MADRS than placebo patients (intent-to-treat; least-squares mean changes: -13.3, -10.8). MADRS response rates were significantly higher with vilazodone than placebo (44% vs 30%, P = .002). Remission rates for vilazodone were not significantly different based on the MADRS (vilazodone, 27.3% vs placebo, 20.3%; P = .066) or HDRS-17 (vilazodone, 24.2% vs placebo, 17.7%; P = .088). Vilazodone-treated patients had significantly greater improvements from baseline in HDRS-17 (P = .026), HDRS-21 (P = .029), HARS (P = .037), CGI-S (P = .004), and CGI-I (P = .004) scores than placebo patients. Rates of discontinuation due to adverse events were 5.1% (vilazodone) and 1.7% (placebo). The most common adverse events (vilazodone vs placebo) were diarrhea (31% vs 11%), nausea (26% vs 6%), and headache (13% vs 10%). Treatment-related effects on sexual function as measured by the CSFQ were small and similar to placebo. Effects on weight were no different from placebo. Vilazodone 40 mg/d was well tolerated and effective in adult patients with MDD. clinicaltrials.gov Identifier: NCT00683592.

Age, Gender, Depression, and Sexual Dysfunction in Taiwan

The effects of age and gender on sexual function have attracted much attention in recent years, though few studies have focused on this issue in Asian populations. The Changes in Sexual Functioning Questionnaire (CSFQ) was used to: (i) assess the differences in sexual functioning between unmedicated outpatients with depressive disorders and healthy volunteers; and (ii) investigate the influences of gender and age on sexual functioning in both groups. The CSFQ was used to assess sexual dysfunction. Two groups of subjects, 73 unmedicated patients with depressive disorders and 116 healthy volunteers, were recruited to the study, and changes in their sexual function were assessed using the CSFQ. Subjects' global depressive level and psychiatric morbidity were assessed using the Taiwanese Depression Questionnaire (TDQ) and the Chinese Health Questionnaire (CHQ). The depressed subjects had significantly lower total CSFQ scores than did the controls. A negative correlation between age and total CSFQ score was found in both genders of depressed patients. Age generally predicted the sum of the CSFQ scores for both genders in the depressed group after controlling for TDQ score; however, a positive correlation between age and total CSFQ score was identified in the female controls. We also found that the S-curve was the best-fit curve for both the male and female controls, the cut-off point for which was the age of 40. Our study confirmed that, as a screening tool for clinically significant sexual dysfunction, the CSFQ offered good sensitivity for both the healthy and depressed subjects. In addition, our findings suggested that age and gender differences should be taken into account when measuring sexual satisfaction. It is possible that the age of 40 could be an anchor point in sexual functioning for the female population of Taiwan.

The association of serotonin transporter genotypes and selective serotonin reuptake inhibitor (SSRI)‐associated sexual side effects: possible relationship to oral contraceptives

To study the relationship between functional variants in the serotonin transporter gene (SLC6A4) and selective serotonin reuptake inhibitor (SSRI)-associated sexual dysfunction. One hundred fifteen subjects aged 18-40 years and currently being treated with an SSRI for depression were assessed for clinical variables known to affect sexual well-being. SSRI-associated sexual difficulties were assessed with the Changes in Sexual Functioning Questionnaire (CSFQ). Subjects were subsequently genotyped for the SLC6A4 promoter region (5HTTLPR) insertion/deletion variant and a variable number of tandem repeats (VNTR) in the second intron. The 5HTTLPR insertion/deletion variant was associated with sexual dysfunction in this study sample [odds ratio (OR) = 2.7; 95% confidence interval (CI) 1.2, 6.4; p = 0.02]. The relationship between promoter genotypes and sexual well-being differed in males and females and was related to whether females were taking an oral contraceptive (OC) medication. Females with the ll genotype were nearly eight times more likely to be categorized as having sexual dysfunction if they were taking OCs, while no relationship was observed in those not taking OCs. These results suggest that a functional variant in the serotonin transporter gene is associated with sexual difficulties in persons taking an SSRI for depression. This relationship may differ by sex and be dependent on OC status in females.

P.3.c.040 Risk of metabolic, cardiologic, and endocrinologic abnormalities in patients under long-term antipsychotic treatment

Polycystic ovary syndrome (PCOS) is a common endocrinologic disorder. Little is known about the effects of PCOS on overall sexual functioning, phases of the sexual response cycle, and sexual satisfaction.To compare the differences in sexual function between women with PCOS and controls, and to assess the relationship of serum testosterone, body mass index (BMI), hirsutism, and acne with sexual function scores in women with PCOS.A cross‐sectional analysis in which women who met the National Institute of Child Health and Human Development criteria for PCOS were compared with a group of healthy volunteers.Results from the validated Changes in Sexual Functioning Questionnaire (CSFQ) were used to assess sexual function. In women with PCOS, serum testosterone levels, BMI, self‐reported hirsutism, and acne were assessed as independent variables.Ninety‐two women with PCOS and 82 controls were studied. Based on total CSFQ scores, sexual dysfunction was present in 27.2% of cases vs. 24.4% of controls (not signifcant). Women with PCOS had a significantly lower orgasm/completion score compared with women in the control group (P < 0.001). Women with PCOS whose testosterone levels were >1 standard deviation above the mean had significantly better sexual functioning vs. those within 1 SD (P = 0.015) and those >1 SD below the mean (P = 0.033). In women with PCOS, increasing BMI was associated with a significant reduction in the orgasm/completion subdomain, but no significant associations were found in regard to acne or hirsutism.Women with PCOS have similar sexual functioning scores compared with controls except in regard to orgasm/completion. The subpopulation of women with PCOS whose serum testosterone levels are in the normal reproductive range are at increased risk for sexual dysfunction. Stovall DW, Scriver JL, Clayton AH, Williams CD, and Pastore LM. Sexual function in women with polycystic ovary syndrome. J Sex Med 2012;9:224–230.

T08-O-07 An integrative approach to sexual dysfunction: psychoanalytic sex terapy

To demonstrate that an Integrative Sex Therapy Model significantly improves sexual problems, and yields better results than a reductionist model of sex therapy. This work will present the cases of 10 female and male patients with sexual dysfunctions who have been attending therapy sessions from October 2006 to October 2007. male or female patient with no organic pathology. organic pathology and severe depression. Parameters for sexual dysfunctions were set in accordance with DSM IV diagnoses, as well as quantitative assessment scales such as -in women- CSFQ (Change in Sexual Functioning Questionnaire), Female Sexual Dysfunction Test, Clinical Global Impression (CGI), Visual Analog Scale (VAS), and -in men- Penile Tumescence Test (RigiScan), Premature Ejaculation (PE) Test, HSD indicators. All patients had previously tried one-method Sexual Therapies. These patients were treated with an Integrative Model in this period. Each patient showed significant improvement with the Integrative Model of Psychotherapeutic Approach, compared to a reductionist diagnosis and treatment. It was observed that 90 percent of patients treated with this integrative model -which focuses on patients’ individual history and current emotional context experienced symptom disappearance as well as depathologization, since they gained an insight about those symptoms. It is important to promote a break with reductionist models that do not integrate deep and situational multi-factorial aspects of sexual problems, leading to the pathologization of sexuality and a lack of understanding of sexual differences.

ORIGINAL RESEARCH—PSYCHOLOGY: Changes in Sexual Functioning Associated with Duloxetine, Escitalopram, and Placebo in the Treatment of Patients with Major Depressive Disorder

Depression and antidepressant therapy have been associated with sexual dysfunction in short-term and point-prevalence trials. This report describes effects of duloxetine and escitalopram on sexual functioning during acute and long-term treatment of major depressive disorder (MDD). In this 8-month, double-blind, placebo-controlled study, adult outpatients with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)-defined MDD were randomized to duloxetine 60 mg/day (N = 273; 173 female), escitalopram 10 mg/day (N = 274; 186 female), or placebo (N = 137; 87 female). After the first 8 weeks of treatment, dose increases were permitted to optimize treatment. The 14-item Changes in Sexual Functioning Questionnaire (CSFQ) was used to assess sexual functioning. Of the 114 patients who did not meet total CSFQ score criteria for global sexual dysfunction at baseline (duloxetine, N = 51; escitalopram, N = 39; placebo, N = 24), the incidence of treatment-emergent sexual dysfunction was significantly higher for escitalopram compared with placebo at 4 and 8 weeks, and significantly higher compared with duloxetine at 4 weeks. At 8 weeks, the incidence of treatment-emergent sexual dysfunction was 17/51 (33.3%) for duloxetine-treated patients; 19/39 (48.7%) for escitalopram-treated patients; and 4/24 (16.7%) for placebo-treated patients (P = 0.01 escitalopram vs. placebo; P = 0.13 duloxetine vs. placebo). After 12 weeks, no significant differences were observed between active drugs. At 8 months, the incidence of treatment-emergent sexual dysfunction was 33.3% for duloxetine, 43.6% for escitalopram, and 25.0% for placebo. Regardless of treatment, patients who achieved remission of MDD showed improvement in global sexual functioning, whereas worsening was observed for patients who did not achieve remission (P < 0.001). Discontinuation rates for sexual side effects did not differ between duloxetine (N = 2) and escitalopram (N = 7) (P = 0.07). Short-term treatment demonstrated a higher incidence of treatment-emergent sexual dysfunction with escitalopram compared with duloxetine and placebo. After 12 weeks, there were no statistically significant differences between drugs; however, MDD outcome (regardless of treatment) had a significant impact on improvement in global sexual functioning.