Top

Published in:

Open Access 01-12-2024 | Fluoxetine | Research

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

Authors: Arman Alipour-Kivi, Negin Eissazade, Seyed Vahid Shariat, Razieh Salehian, Shiva Soraya, Sanaz Askari, Mohammadreza Shalbafan

Published in: BMC Psychiatry | Issue 1/2024

Abstract

Introduction

Selective 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).

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. 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.

Results

Sixty-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.

Conclusions

Drug 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 registration

The trial was registered at the Iranian Registry of Clinical Trials on 2021.10.25 (www.irct.ir; IRCT ID: IRCT20170123032145N6) before the trial.

GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990–2019: a systematic analysis for the global burden of Disease Study 2019. Lancet Psychiatry. 2022;9(2):137–50. https://doi.org/10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.CrossRefPubMedCentral

Edinoff AN, Akuly HA, Hanna TA, Ochoa CO, Patti SJ, Ghaffar YA, Kaye AD, Viswanath O, Urits I, Boyer AG, Cornett EM, Kaye AM. Selective serotonin reuptake inhibitors and adverse effects: a narrative review. Neurol Int. 2021;13(3):387–401. https://doi.org/10.3390/neurolint13030038.CrossRefPubMedPubMedCentral

Taylor MJ, Rudkin L, Bullemor-Day P, Lubin J, Chukwujekwu C, Hawton K. Strategies for managing sexual dysfunction induced by antidepressant medication. Cochrane Database of Systematic Reviews. 2013, Issue 5. Art. No.: CD003382. https://doi.org/10.1002/14651858.CD003382.pub3. Accessed 29 March 2023.

Healy D. Post-SSRI sexual dysfunction & other enduring sexual dysfunctions. Epidemiol Psychiatr Sci. 2019;29:e55. https://doi.org/10.1017/S2045796019000519.CrossRefPubMedPubMedCentral

Montejo A, Majadas S, Rizvi SJ, Kennedy SH. The effects of agomelatine on sexual function in depressed patients and healthy volunteers. Hum Psychopharmacol. 2011;26(8):537–42. https://doi.org/10.1002/hup.1243. Epub 2011 Nov 21.CrossRefPubMed

Rosen RC, Lane RM, Menza M. Effects of SSRIs on sexual function: a critical review. J Clin Psychopharmacol. 1999;19(1):67–85. https://doi.org/10.1097/00004714-199902000-00013.CrossRefPubMed

Jing E, Straw-Wilson K. Sexual dysfunction in selective serotonin reuptake inhibitors (SSRIs) and potential solutions: a narrative literature review. Ment Health Clin. 2016;6(4):191–6. https://doi.org/10.9740/mhc.2016.07.191.CrossRefPubMedPubMedCentral

Moore BE, Rothschild AJ. Treatment of antidepressant-induced sexual dysfunction. Hosp Pract (1995). 1999;34(1):89–91, 95– 6. https://doi.org/10.3810/hp.1999.01.127.

Shalbafan M, Saeedi V, Kamalzadeh L. Significant improvement of risperidone-induced retrograde ejaculation on drug holidays: a case report. Psychiatry and Clinical Psychopharmacology. 2019;29(1):120–2.CrossRef

10.

de Filippis R, Solerdelcoll M, Shalbafan M. Editorial: safety and side effects of psychotropic medications. Front Psychiatry. 2023;14:1148158. https://doi.org/10.3389/fpsyt.2023.1148158.CrossRefPubMedPubMedCentral

11.

Rothschild AJ. Selective serotonin reuptake inhibitor-induced sexual dysfunction: efficacy of a drug holidays. Am J Psychiatry. 1995;152(10):1514–6. https://doi.org/10.1176/ajp.152.10.1514.CrossRefPubMed

12.

Rosen RC, Catania J, Pollack L, Althof S, O’Leary M, Seftel AD. Male sexual health questionnaire (MSHQ): scale development and psychometric validation. Urology. 2004;64(4):777–82. https://doi.org/10.1016/j.urology.2004.04.056.CrossRefPubMed

13.

Goldberg DP, Hillier VF. A scaled version of the General Health Questionnaire. Psychol. Med. 1979;9:139–45. https://doi.org/10.1017/S0033291700021644.CrossRef

14.

Lalegani E, Eissazade N, Shalbafan M, Salehian R, Shariat SV, Askari S, Orsolini L, Soraya S. Safety and Efficacy of Drug holidays for women with sexual Dysfunction Induced by selective serotonin reuptake inhibitors (SSRIs) other than fluoxetine: an open-label Randomized Clinical Trial. Brain Sci. 2023;13(10):1397. https://doi.org/10.3390/brainsci13101397.CrossRefPubMedPubMedCentral

15.

Taghavi M. Assessment of the Validity and Reliability Ofthe General Health Questionnaire. J Psychol. 2001;5(3):381–98.

16.

Fakhri A, Morshedi H, Soleymanian A. Psychometric properties of Iranian Version of male sexual function index. Jundishapur Sci Med J. 2014;12(6):655–63.

17.

Keltner NL, McAfee KM, Taylor CL. Mechanisms and treatments of SSRI-induced sexual dysfunction. Perspect Psychiatr Care. 2002 Jul-Sep;38(3):111–6.

18.

Nitkowska M, Tomasiuk R, Czyżyk M, Friedman A. Prolactin and sex hormones levels in males with parkinson’s disease. Acta Neurol Scand. 2015;131:411–6.CrossRefPubMed

19.

Abbasinazari M, Heidari-Kord M, Mazaheri-Meybodi A, Eshraghi A, Bayati N. Plasma oxytocin level and sexual dysfunction in Depressed Women treated by either fluoxetine or Citalopram: a pilot clinical trial. Iran J Pharm Res 2018 Winter;17(1):408–14.

20.

Pavlidi P, Kokras N, Dalla C. Antidepressants’ effects on testosterone and estrogens: what do we know? Eur J Pharmacol. 2021;899:173998. https://doi.org/10.1016/j.ejphar.2021.173998. Epub 2021 Mar 4.CrossRefPubMed

21.

Dhir A, Kulkarni K. Nitric oxide (NO) system in Major Depression: studies on NO synthase inhibitors as antidepressant agents. Curr Enzym Inhib. 2016;12(1):40–8. https://doi.org/10.2174/1573408012666151126185543.CrossRef

22.

Healy D, LaPalme J, Levin M, Post-SSRI, Sexual Dysfunction. A Bioelectric Mechanism? Bioelectricity. 2020;2(1):7–13. https://doi.org/10.1089/bioe.2019.0010. Epub 2020 Mar 18.CrossRefPubMed

23.

Campos AI, Mulcahy A, Thorp JG, Wray NR, Byrne EM, Lind PA, Medland SE, Martin NG, Hickie IB, Rentería ME. Understanding genetic risk factors for common side effects of antidepressant medications. Commun Med (Lond). 2021;1:45. https://doi.org/10.1038/s43856-021-00046-8.CrossRefPubMed

24.

Montejo AL, Prieto N, de Alarcón R, Casado-Espada N, de la Iglesia J, Montejo L. Management strategies for antidepressant-related sexual dysfunction: a clinical Approach. J Clin Med. 2019;8(10):1640. https://doi.org/10.3390/jcm8101640.CrossRefPubMedPubMedCentral

Title: 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
Authors: Arman Alipour-Kivi
Negin Eissazade
Seyed Vahid Shariat
Razieh Salehian
Shiva Soraya
Sanaz Askari
Mohammadreza Shalbafan
Publication date: 01-12-2024
Publisher: BioMed Central
Keyword: Fluoxetine
Published in: BMC Psychiatry / Issue 1/2024
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-024-05507-7

2024 ASCO Annual Meeting

Springer Medicine

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

Introduction

Methods

Results

Conclusions

Trial registration

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusions

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2024

Exploring early life social and executive function development in infants and risk for autism: a prospective cohort study protocol of NICU graduates and infants at risk for cerebral palsy

Moderating effect of alexithymia between problem gambling and psychotic experiences in university students

Association between social support and the severity of positive symptoms in rural community-dwelling patients with schizophrenia during the COVID-19 pandemic

Prevalence and factors associated with dyslipidemia in patients with first hospitalization for major depressive disorder: a large sample cross-sectional study

The impact of early intervention psychosis services on hospitalisation experiences: a qualitative study with young people and their carers

Comparing attitudes towards compulsory interventions in severe and persistent mental illness among psychiatrists in India and Switzerland