Decreased Sexual Desire Screener

Decreased Sexual Desire Screener‌

ANITA H. CLAYTON,University of Virginia

EVAN R. GOLDFISCHERHudson Valley Urology, Poughkeepsie, NY

IRWIN GOLDSTEINAlvarado Hospital, San Diego

LEONARD R. DEROGATISCenter for Sexual Medicine at Sheppard Pratt, Baltimore

DIANE J. LEWIS-D’AGOSTINO AND ROBERT PYKEBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT

The Decreased Sexual Desire Screener (DSDS) is a brief diagnostic instrument to assist in making the diagnosis of generalized acquired Hypoactive Sexual Desire Disorder (HSDD) in pre-, peri- and postmenopausal women. The DSDS has been validated for use by clinicians who are neither trained nor specialized in the diagnosis of Female Sexual Dysfunction (FSD).

Description

The DSDS consists of four Yes or No questions (“In the past, was your level of sexual desire or interest good and satisfying to you?” “Has there been a decrease in your level of sexual desire or interest?” “Are you bothered by your decreased level of sexual desire or interest?” “Would you like your level of sexual desire or interest to increase?”) and a fifth, seven-part question covering factors relevant to the differential diagnosis of HSDD.

The DSDS was developed specifically to assist clinicians in identifying generalized acquired HSDD and not to diagnose or exclude other female sexual disorders (e.g., Female Sexual Arousal Disorder [FSAD] or Female Orgasmic Disorder [FOD]), although these may be concur- rent with HSDD.

The validity of the DSDS was demonstrated in a non- treatment study (Clayton et al., 2009) and during the screening period of two Phase III trials of flibanserin (a 5- HT1A agonist/5-HT2A antagonist currently in development as a potential treatment for generalized acquired HSDD;

Goldfischer, Clayton, Goldstein, Lewis-D’Agostino, & Pyke, 2008; Nappi, Dean, Hebert, & Pyke, 2008). The understandability of the DSDS to women and the adequacy of the items for diagnosis by clinicians who were neither trained nor specialized in the diagnosis of FSD were also evaluated in the nontreatment study (Clayton et al., 2009).

Response Mode and Timing

Patients are to answer the first four Yes or No questions relating to whether their sexual desire has decreased and whether this bothers them, and then check all the factors in Question 5 that they feel may be contributing to the decrease in sexual desire or interest that they are currently experiencing. Subsequently, their responses are reviewed with them, and adjusted if needed, by a clinician, who decides whether a diagnosis of generalized acquired HSDD according to the DSM-IV-TR criteria (American Psychiatric Association, 2000) is warranted.

Scoring

If the patient answers No to any of the questions 1 through 4, then she does not qualify for a diagnosis of generalized acquired HSDD. If a patient answers Yes to all of the questions 1 through 4 and No to all of the factors in Question 5 after clinician review, she would meet the criteria for a diagnosis of generalized acquired HSDD. If the patient answers Yes to all of the questions 1 through 4 and Yes to any of the factors in Question 5, then the clinician would decide whether a primary diagnosis other than generalized acquired HSDD is more appropriate. Comorbid conditions such as FSAD or FOD do not rule out a concurrent diagnosis of HSDD.

Validity

The validity of the DSDS was established in a nontreatment validation study (Clayton et al., 2009) and during the screening period of a Phase III randomized withdrawal trial of flibanserin known as the Researching Outcomes on Sustained Efficacy (ROSE) study (Goldfischer et al., 2008).

The nontreatment study included 263 pre-, peri- and post- menopausal women aged 18 to 50 years with and without FSD (141 subjects had a primary diagnosis of HSDD, 47 subjects had a primary diagnosis of another FSD [i.e., not HSDD], 75 subjects had no FSD). A total of 921 premenopausal women aged ≥18 years with decreased sexual desire were screened for enrollment into the ROSE study. Both studies were conducted in North America. Participants in both studies were required to be in a stable, communicative, monogamous heterosexual relationship with a sexually functional partner for at least 1 year. Participants were excluded if they had any clinically significant condition or had used any medication that was likely to affect their sexual function within the previous 4 weeks.

Participants completed the DSDS at screening and their responses were reviewed with a clinician who was neither trained nor specialized in FSD (nonexpert clinician), who decided whether a diagnosis of generalized acquired HSDD was warranted. A clinician who was an expert in FSD then independently conducted an extensive diagnostic interview to diagnose sexual disorders. The diagnoses obtained using the two methods (generalized acquired HSDD or not) were compared. In the nontreatment study, the sensitivity and specificity of the DSDS were .836 and .878, respectively. In the ROSE study, the sensitivity of the DSDS was .946; specificity was not calculated, as this was a clinical population of women with complaints of low sexual desire.

Feedback on the use of the DSDS from a debriefing exercise involving a subset of 89 women in the nontreatment study showed that 85.4% of participants were able to understand all five questions. Further, nonexpert clinicians who were debriefed on how useful the DSDS was after 253 of the 263 interviews indicated that they could use the tool to reliably rule in or out HSDD in 93% of cases.

The validity of the DSDS was established in a sample of 513 premenopausal European women aged ≥18 years with decreased sexual desire who were screened for enrollment into the eurOpean ResearCH In Decreased sexual desire (ORCHID) trial, a Phase III trial of flibanserin in Decreased Sexual Desire Screener ©

Please answer the following questions: Name:

premenopausal women with HSDD (Nappi et al., 2008). Using the same methodology as described above (with patients completing the DSDS in their own language), the sensitivity of the DSDS in this sample was .956.

Other Information

Copyright © Boehringer Ingelheim International GmbH 2005. All rights reserved. Any use or reproduction of this questionnaire by a commercial organization without written authorization is prohibited.

Address correspondence to Anita Clayton, University of Virginia Health System, Department of Psychiatric Medicine, 2955 Ivy Road, Northridge Suite 210, Charlottesville, VA 22903; e-mail: [email protected]

Age:

NO

Date:

/ /

YES

NO

YES

NO

YES

NO

YES

  1. In the past, was your level of sexual desire or interest good and satisfying to you?

  2. Has there been a decrease in your level of sexual desire or interest?

  3. Are you bothered by your decreased level of sexual desire or interest?

  4. Would you like your level of sexual desire or interest to increase?

  5. Please check all the factors that you feel may be contributing to your current decrease in sexual desire or interest:

NO

YES

A. An operation, depression, injuries, or other medical condition

B. Medications, drugs or alcohol you are currently taking

C. Pregnancy, recent childbirth, menopausal symptoms

D. Other sexual issues you may be having (pain, decreased arousal or orgasm)

E. Your partner’s sexual problems

F. Dissatisfaction with your relationship or partner

G. Stress or fatigue

Goldfischer ER, Clayton AH, Goldstein I, Lewis-D’Agostino DJ, Pyke R. Decreased Sexual Desire Screener© (DSDS©) for diagnosis of Hypoactive Sexual Desire Disorder in women. Poster presented at the ACOG annual meeting, 3–7 May 2008, New Orleans, USA.

©Boehringer Ingelheim International GmbH 2005. All rights reserved. Any use or reproduction of this questionnaire by a commercial organization without written authorization prohibited.

Brief Diagnostic Assessment for Generalized Acquired Hypoactive Sexual Desire Disorder (HSDD)

Clinician:

Verify with the patient each of the answers she has given.

The Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision® characterizes Hypoactive Sexual Desire Disorder (HSDD) as a deficiency or absence of sexual fantasies and desire for sexual activity, which causes marked distress or inter- personal difficulty, and which is not better accounted for by a medical, substance-related, psychiatric, or other sexual condition. HSDD can be either generalized (not limited to certain types of stimulation, situations, or partners) or situational, and can be either acquired (develops only after a period of normal functioning) or lifelong. To determine if symptoms are acquired, ask if there was a period of normal functioning at any time in the past.‌

If the patient answers “NO” to any of the questions 1 through 4, then she does not qualify for the diagnosis of generalized, acquired HSDD.

If the patient answers “YES” to all of the questions 1 through 4, and your review confirms

“NO” answers to all of the factors in question 5, then she does qualify for the diagnosis of generalized, acquired HSDD.

If the patient answers “YES” to all of the questions 1 through 4 and “YES” to any of the

factors in question 5, then decide if the answers to question 5 indicate a primary diagnosis other than generalized, acquired HSDD. Co- morbid conditions such as arousal or orgasmic disorder do not rule out a concurrent diagnosis of HSDD.

Based on the above, does the patient have generalized acquired Hypoactive Sexual Desire Disorder?

YES

NO

Thank you.

Goldfischer ER, Clayton AH, Goldstein I, Lewis-D’Agostino DJ, Pyke R. Decreased Sexual Desire Screener© (DSDS©) for diagnosis of Hypoactive Sexual Desire Disorder in women. Poster presented at the ACOG annual meeting, 3–7 May 2008, New Orleans, USA.

©Boehringer Ingelheim International GmbH 2005. All rights reserved. Any use or reproduction of this questionnaire by a commercial organization without written authorization prohibited.

References

American Psychiatric Association. (2000). Diagnostic and statistical manual of mental disorders (4th ed., text rev.). Washington, DC: Author.

Clayton, A. H., Goldfischer, E. R., Goldstein, I., Derogatis, L., Lewis- D’Agostino, D. J., & Pyke, R. (2009) Validation of the Decreased Sexual Desire Screener (DSDS): A brief diagnostic instrument for generalized acquired female Hypoactive Sexual Desire Disorder (HSDD). Journal of Sexual Medicine, 6, 730–738.

Goldfischer, E. R., Clayton, A. H., Goldstein, I., Lewis-D’Agostino, D. J., & Pyke, R. (2008). Decreased Sexual Desire Screener© (DSDS©) for diagnosis of Hypoactive Sexual Desire Disorder in women. Obstetrics and Gynecology, 111, 109S.

Nappi, R., Dean, J., Hebert, A., & Pyke, R. (2008, December). Decreased Sexual Desire Screener (DSDS) for diagnosis of Hypoactive Sexual Desire Disorder (HSDD) in European women. Poster presented at the Joint Congress of the European and International Societies for Sexual Medicine, Brussels, Belgium.