Assessing the onset of antidepressant-induced sexual dysfunction using interactive voice response technology.
BACKGROUND
Sexual dysfunction is a symptom of major depression, as well as a common complication of treatment with many classes of antidepressants. Nonetheless, the various forms of sexual dysfunction continue to be underreported in clinical practice, despite the availability of validated scales such as the Changes in Sexual Functioning Questionnaire (CSFQ). The current study was designed to evaluate the validity of obtaining CSFQ data using interactive voice response (IVR) technology.


METHODS
Sexually active, healthy male volunteers (N = 99; mean age of 31 years) were randomly assigned to 3 weeks of double-blind, parallel-group treatment with paroxetine (20 mg/day); CP-448,187 (3 mg/day); or placebo. Patients completed both paper-and-pencil and IVR versions of the 14-item CSFQ at baseline and on treatment days 8, 15, and 21. Additional IVR assessments were obtained at days 2, 4, and 6, permitting assessment of changes between office visits. This study was conducted between March and May 2001.


RESULTS
The overall correlation between the paper and IVR CSFQ total score was r = 0.96 (p < .0001). Similarly, high correlations were found between paper and IVR assessment methods on the individual CSFQ subscales: pleasure (r = 0.88), frequency (r = 0.88), interest (r = 0.93), arousal (r = 0.89), and orgasm (r = 0.92; p < .0001 for all comparisons). Both assessment methods were able to detect a statistically significant between-group difference in sexual functioning by day 8, which remained significant throughout the remainder of the study. Both assessment methods found SSRI-related sexual dysfunction to include significant effects on all CSFQ domains. Assessments using IVR collected from subjects at home on days 2, 4, and 6 identified onset of sexual dysfunction by day 4, before it was detected during scheduled office visits.


CONCLUSIONS
Interactive voice response assessment of sexual dysfunction on the CSFQ was found to be highly correlated with previously validated paper-and-pencil assessment. Interactive voice response provides a valid, easy-to-administer alternative method for obtaining systematic data on the impact of antidepressant treatment on sexual functioning. More frequent assessment by IVR enables more precise evaluation of symptom onset.
Dunn
Judith A
JA
Pfizer Global Research and Development, New London, Conn., USA.
Arakawa
Renee
R
Greist
John H
JH
Clayton
Anita H
AH
D000328:Adult; D003625:Data Collection / Q000379:methods; D004311:Double-Blind Method; D001330:Electronic Data Processing / Q000379:methods; D006801:Humans; D008297:Male; D009819:Office Visits; D017374:Paroxetine / Q000009:adverse effects* / Q000627:therapeutic use; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced* / Q000175:diagnosis; D020018:Sexual Dysfunctions, Psychological / Q000139:chemically induced* / Q000175:diagnosis; D011795:Surveys and Questionnaires; D014831:Voice
D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors