The effect of drug holidays on sexual dysfunction in men treated with selective serotonin reuptake inhibitors (SSRIs) other than fluoxetine: An 8-week open-label randomized clinical trial

Abstract

Abstract Introduction: Mental disorders are a significant global burden, with selective serotonin reuptake inhibitors (SSRIs) being widely used for treatment. However, SSRIs are associated with various side effects, including sexual dysfunction. Common and persistent, these side effects often lead to poor adherence and treatment discontinuation. While several strategies have been employed to manage SSRI-induced sexual dysfunction, drug holidays have not been extensively studied for this purpose. Therefore, this clinical trial aims to assess the effect of drug holidays on sexual dysfunction in men treated with SSRIs, excluding fluoxetine. Methods: This 8-week double-center, randomized, open-label, controlled trial was conducted in the outpatient clinics of Iran Psychiatric Hospital and Tehran Institute of Psychiatry, from January 2022 to March 2023. The study included married men between the ages of 18 and 50 years who had experienced sexual dysfunction during treatment with an SSRI. The Male Sexual Health Questionnaire (MSHQ) and the 28-Question General Health Questionnaire (GHQ-28) were used as assessment tools. Participants were randomized into two groups: the drug holidays group and the control group. The drug holidays group was instructed not to take their medications on the weekends. The control group was asked to continue their regular medication regimen without any changes. Both groups were assessed at baseline, and weeks 4 and 8. Results: Sixty-three patients were included and randomly assigned to drug holidays (N=32) or control (N=31) groups, and 50 patients (25 in each group) completed the trial. The participants’ mean (±SD) age was 37.22 (±12.181). Drug holidays significantly improved erection, ejaculation, satisfaction, and overall sexual health of the participants (P<0.001).. No significant change was observed in the drug holidays group’s mental health. No major side effects were recorded. Conclusions: Based on the results of our study, drug holidays was significantly in favor of ‘erection’, ‘ejaculation’, ‘satisfaction’ and ‘total’ scores of the MSHQ, indicating improvement in sexual health of men, without significant worsening of mental health status. Further research is needed to reach a certain conclusion. Trial registration: The trial was registered at the Iranian Registry of Clinical Trials on 25/10/2021 (www.irct.ir; IRCT ID: IRCT20170123032145N6) before the trial.