Trial reportBMC psychiatry2024
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.
Trial report in BMC psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 6 citations in OpenAlex.
- The Off-Label Use of Selective Serotonin Reuptake Inhibitors for Sexual Behavior Management: Risks and Considerations.Healthcare (Basel, Switzerland) · 2025Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
introductionSelective serotonin reuptake inhibitors (SSRIs) are widely used for the treatment of various mental disorders. Sexual dysfunction is one of the most common side effects of SSRIs, and often leads to poor adherence and treatment discontinuation. While several strategies have been employed to manage SSRI-induced sexual dysfunction, drug holidays has not been extensively studied for this purpose. This clinical trial aims to assess the effect of drug holidays on sexual dysfunction in married men under treatment with SSRIs other than fluoxetine (as its long half-life makes drug holidays ineffective).
methodsThis 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. We included married men aged between18 and 50 years who had experienced sexual dysfunction during treatment with SSRIs, other than fluoxetine. The Male Sexual Health Questionnaire (MSHQ) and the 28-Question General Health Questionnaire (GHQ-28) were used for the assessment of sexual function and mental health status. 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.
resultsSixty-three patients were included and randomly assigned to the drug holidays group (N = 32) or the control group (N = 31). Fifty patients (25 in each group) completed the trial. Drug holidays significantly improved erection, ejaculation, satisfaction, and the overall sexual health of the participants (P < 0.001). No significant change was observed in their mental health status. No major side effects were recorded.
conclusionsDrug holidays significantly improved the MSHQ scores in 'erection', 'ejaculation', 'satisfaction' and 'total' in married men with sexual dysfunction induced by SSRIs, other than fluoxetine, without causing any significant changes in their mental health status. Further research is needed to reach a certain conclusion.
trial registrationThe trial was registered at the Iranian Registry of Clinical Trials on 2021.10.25 ( www.irct.ir ; IRCT ID: IRCT20170123032145N6) before the trial.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.