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.

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.

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.

Selective serotonin reuptake inhibitors (SSRIs) are the cornerstone of psychopharmacology. However, they cause side effects such as sexual dysfunction, leading to the discontinuation of treatment. We aimed to investigate the efficacy and safety of drug holidays for women experiencing sexual dysfunction Induced by SSRIs other than fluoxetine. This study was an 8-week randomized, open-label, controlled trial including married women aged between 18 and 50 years who had experienced sexual dysfunction while undergoing treatment with SSRIs. The intervention group implemented drug holidays by not taking medications on Thursdays and Fridays, while the control group continued regular medication use. The female sexual function index (FSFI) and the 28-question general health questionnaire (GHQ-28) were administered to assess sexual function and mental health, respectively. A total of 50 participants completed the trial. The drug holidays' group showed significant improvements in arousal (p < 0.001), desire (p = 0.001), orgasm (p < 0.001), satisfaction (p < 0.001), lubrication (p = 0.021), and overall sexual health (p < 0.001). The between-group difference of pain was significant (p < 0.001), despite no significant within-group change. Mental health improved in both groups, despite no significant between-group difference. No major adverse effects were reported. Drug holidays did not introduce immediate safety concerns or significant adverse effects during the timeframe of eight weeks, suggesting that it may be a safe and effective strategy for managing SSRI-induced sexual dysfunction in women, alongside improving mental health. Further research is needed to reach a definitive conclusion.

Agomelatine augmentation of sertraline in the treatment of moderate to severe obsessive-compulsive disorder: a randomized double-blinded placebo-controlled clinical trial.

BACKGROUND: As 40-60% of the patients with obsessive-compulsive disorder (OCD) do not adequately respond to the first-line treatment, finding an effective second-line treatment is required. Our aim was to assess the efficacy and safety of agomelatine (a selective melatonin receptor agonist and a 5-hydroxytryptamine (HT)2 C antagonist) augmentation of sertraline in the treatment of patients with moderate to severe OCD. METHODS: In this 12-week randomized, double-blinded, placebo-controlled, parallel-group clinical trial, 65 patients with moderate to severe OCD according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5) criteria and a Yale-Brown obsessive compulsive scale (Y-BOCS) score of over 21, were included. They were assigned with sertraline (100 mg/day for the first 4 weeks and 200 mg/day for the next 8 weeks) and either agomelatine (25 mg/day) or placebo. The primary outcome was OCD symptoms measured by the Y-BOCS. RESULTS: Fifty patients (24 in agomelatine group and 26 in placebo group) completed the trial. The Y-BOCS scores in total (MD (95% CI) = 12.25 (11.00, 13.49) (P < 0.001) vs. MD (95% CI) = 12.46 (6.65, 15.74) (P < 0.001)), the obsession subscale (MD (95% CI) = 5.04 (4.19, 5.88) (P < 0.001) vs. MD (95% CI) = 5.00 (3.84, 6.16) (P = 0.0001)), and compulsion subscale (MD (95% CI) = 7.21 (6.34, 8.07) (P < 0.001) vs. MD (95% CI) = 7.460 (6.50, 8.42) (P < 0.001)) significantly decreased in both groups. Although, at the end of the trial, no significant difference was observed between the scores of the two groups in total (MD (95% CI) = 0.480 (-1.23, 2.19) (P = 0.78)), the obsession subscale (MD (95% CI) = 1.020 (-0.15, 2.19) (P = 0.38)), and the compulsion subscale (MD (95% CI) = 0.540 (-0.34, 1.42) (P = 0.54)). No major adverse effects were recorded, and the frequency of side effects was not significantly different between the groups. CONCLUSION: Agomelatine in augmentation with sertraline is safe and tolerable in patients with moderate to severe OCD. However, our study does not support its efficacy in improving OCD symptoms, compared to placebo. TRIAL REGISTRATION: The trial was registered at the Iranian Registry of Clinical Trials on 14/07/2020 ( www.irct.ir ; IRCT ID: IRCT20170123032145N5).

The Impact of the COVID-19 Pandemic on Iranian Psychiatric Trainees' and Early Career Psychiatrists' Well-being, Work Conditions, and Education.

OBJECTIVES: This study was conducted to investigate the impact of the COVID-19 pandemic on psychiatric trainees and early career psychiatrists in Iran. METHODS: In this cross-sectional survey, the authors used a 24-item questionnaire inquiring about the sociodemographic characteristics of the participants, their views on the impact of the COVID-19 pandemic on their professional careers, methods of education, workplace environment, well-being and mental health, and the use of telepsychiatry in Iran. RESULTS: A total of 159 responses were received. The majority (n=124, 78.0%) reported that "some but not all obligatory activities have been converted to online activities." Most of the participants (n=103, 64.8%) stated that the pandemic had not affected the duration of their training. Less than half (n=61, 38.4%) reported that their well-being had been affected rather negatively. Some (n=59, 37.1%) reported that their supervisors or coworkers had no significant impact on their well-being, whereas others (n=53, 33.3%) reported a rather positive impact. Almost half of the participants (n=78, 49.0%) did not have access to free psychological counseling. In addition, more than half (n=89, 56.0%) reported that there were no recommendations on how to proceed with telepsychiatry. CONCLUSIONS: This study calls for improvements in the education and well-being of psychiatric trainees and early career psychiatrists in Iran amid the COVID-19 pandemic. Additional research should be carried out to maximize learning, provide mental health care, and use telepsychiatry.

Memantine augmentation of sertraline in the treatment of symptoms and executive function among patients with obsessive-compulsive disorder: A double-blind placebo-controlled, randomized clinical trial.

BACKGROUND: Medications currently recommended for the treatment of Obsessive-Compulsive Disorder (OCD) usually decrease the severity of the symptoms by 20-30%; however, 40-60% of OCD patients do not achieve a satisfactory response. Our main objective was to investigate the effectiveness of memantine, a non-competitive N-Methyl-D-aspartate (NMDA) receptor antagonist, as an adjunct therapy to sertraline, a selective serotonin reuptake inhibitor (SSRI), to improve severity of symptoms and executive function among patients with obsessive-compulsive disorder. METHODS: Seventy patients with OCD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, and a Yale-Brown obsessive compulsive scale (Y-BOCS) score of more than 21 were recruited to the study. They received sertraline (100 mg daily initially followed by 200 mg daily after week 4) and either memantine (10 mg twice daily) or placebo in a placebo controlled, double-blinded, parallel-group, clinical trial of 12 weeks. The primary outcome was OCD symptoms measured by the Y-BOCS. Moreover, executive function of participants was measured by the Wisconsin Card Sorting Test (WCST). RESULTS: The total score, and obsession and compulsion subscales of Y-BOCS significantly dropped in both groups with no significant difference between the two groups. However, memantine group showed a greater response in the number of completed categories subscale of the WCST (p value<0.001). We did not observe any major adverse effects in any of the groups. CONCLUSION: Memantine has an acceptable safety and tolerability in patients with OCD and might have a positive effect on their executive function. Nevertheless, the current results don`t support the efficacy of memantine as an adjunctive agent to sertraline for symptoms in patients with OCD. TRIAL REGISTRATION: The trial was registered at the Iranian Registry of Clinical Trials on 04/10/2019 ( www.irct.ir ; IRCT ID: IRCT20170123032145N4).