Incidence of sexual side effects in refractory depression during treatment with citalopram or paroxetine.
OBJECTIVE
The incidence of sexual dysfunction due to antidepressant drugs reported in pre-marketing clinical efficacy trials is often several times lower than in subsequent clinical experiences and independent reports. Although it is commonly believed that the reason for this discrepancy is that the nonleading questions employed in conventional clinical trials underestimate sexual dysfunction while the direct questioning used in independent trials provides more accurate data, few studies have actually compared these 2 methods.


METHODS
In this study, 119 patients with a DSM-IV-defined major depressive episode (82 women and 37 men) who had been treated with but not responded to a selective serotonin reuptake inhibitor (SSRI; either citalopram or paroxetine) were assessed regarding sexual functioning by means of open-ended questions and direct questioning at baseline (after SSRI treatment only) and after 4 weeks of SSRI treatment plus buspirone or placebo.


RESULTS
More patients reported sexual dysfunction in response to direct questioning (41%) as compared with spontaneous report (6%) (p < .001). Sexual dysfunction correlated with the duration of the depressive episode, but not with age, dose of SSRI, plasma level of SSRI, duration of SSRI treatment, or any measurement of depression. No statistically significant differences regarding the incidence of sexual dysfunction were found between the citalopram and the paroxetine groups.


CONCLUSIONS
Open-ended questions are an insufficient tool to estimate sexual dysfunction, and premarketing clinical trials should therefore include basic explicit assessments. The failure to find a correlation between treatment duration and sexual dysfunction adds to the notion that sexual side effects due to SSRIs do not abate over time.
Landén
Mikael
M
Section of Psychiatry St. Göran, Department of Clinical Neuroscience, Karolinska Institutet, SE 112 81, Stockholm, Sweden. mikael.landen@cns.ki.se
Högberg
Per
P
Thase
Michael E
ME
D002065:Buspirone / Q000627:therapeutic use; D015283:Citalopram / Q000009:adverse effects* / Q000627:therapeutic use; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009664:Norway / Q000453:epidemiology; D017374:Paroxetine / Q000009:adverse effects* / Q000627:therapeutic use; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D015203:Reproducibility of Results; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D020018:Sexual Dysfunctions, Psychological / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology; D011795:Surveys and Questionnaires; D013548:Sweden / Q000453:epidemiology
D002065:Buspirone; D015283:Citalopram; D017374:Paroxetine; D010919:Placebos; D017366:Serotonin Receptor Agonists; D017367:Selective Serotonin Reuptake Inhibitors