Adjunctive Treatment with Lodenafil Carbonate for Erectile Dysfunction in Outpatients with Schizophrenia and Spectrum: A Randomized, Double-Blind, Crossover, Placebo-Controlled Trial

Abstract

Introduction Evidence is accumulating to support the presence of erectile dysfunction in patients with schizophrenia. This dysregulation may be amenable to therapeutic intervention to improve adherence and quality of life of patients who suffer from schizophrenia and schizoaffective disorders. Aim We aimed to evaluate the use of adjunctive medication lodenafil for the treatment of erectile dysfunction in outpatients with schizophrenia and spectrum. Methods The design was a randomized, double-blind, crossover, placebo-controlled trial with lodenafil and it was carried at the Schizophrenia Outpatients Program. Main Outcome Measures The measures used to assess sexual dysfunction were Arizona Sexual Experiences Scale (ASEX) and International Index of Erectile Function (IIEF). The Positive and Negative Syndrome Scale (PANSS) and the Quality of Life Scale (QLS) were also used. The measures included the levels of prolactin, estradiol, luteinizing hormone, sex hormone-binding globulin, free testosterone, and total testosterone at baseline and end point. Lodenafil and placebo pills were used by the patients for 16 weeks. Results Fifty male outpatients fulfilled the criteria and 94% of the participants completed the study. Lodenafil and placebo produced improvement in ASEX, IIEF scale, PANSS, and QLS, and there was no statistical difference between lodenafil and placebo groups in all sexual domains in the results of PANSS and QLS and in the results of hormone levels. Conclusion These results indicate that both lodenafil and placebo were effective in the treatment of erectile dysfunction for schizophrenia. Placebo effect is very important in patients with schizophrenia and this study showed the importance of discussing sexuality and trying to treat these patients. Further studies designed to test treatments of erectile dysfunction in patients who suffer from schizophrenia are necessary.

Add-on mirtazapine improves orgasmic functioning in patients with schizophrenia treated with first-generation antipsychotics

“…According to the findings from studies on Major Depressive Disorder, mirtazapine itself may carry some sexual side effects, although estimates of their prevalence remain lower than for the majority of other antidepressants (13). However, in some studies mirtazapine demonstrated favourable effects on sexual dysfunction in depressed patients (14). Mirtazapine has also repeatedly accompanied improvements in several symptoms of sexual dysfunction caused by SSRIs (15,16), although these data remain equivocal (17).…”

“…Another possible strategy for improving sexual functioning in schizophrenia may be add-on treatment with mirtazapine, an antidepressant that carries a seemingly low risk of sexual dysfunction in patients with depression (13). Hypothetically, mirtazapine, an antidepressant with a serotonin 5HT-2a/c receptor blocking properties added to a pure D2 receptor blocker (i.e., FGA), may emulate the receptor profile of an SGA and, thus, improve sexual functioning (14).…”

Pharmacotherapy for Erectile Dysfunction: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015)

“…27 There also is evidence that lodenafil is efficacious in the treatment of ED in men with ED and schizophrenia. 244 There were no significant differences between the lodenafil and placebo groups. Therefore, it cannot be recommended.…”

Structured review of the use of the Arizona sexual experiences scale in clinical settings

“…An investigation of augmentation with cabergoline in patients (n = 80) receiving a range of antipsychotics found a reduction in prolactin levels with cabergoline treatment in all patients, with mean levels of 73.3 ng/mL (±46.8) to 42.0 ng/mL (±27.8) at month 3 and 27.1 ng/mL (± =20.4) at month 6: mean total ASEX scores also declined, from 19.1 (±5.1) to 17.6 (±5.5) at month 3, and 15.0 (±6.5) at month 6 (Kalkavoura et al, 2013). Finally, a randomized, double-blind, crossover, placebo-controlled investigation of lodenafil in male patients (n = 50) with schizophrenia and erectile dysfunction found that both lodenafil and placebo were associated with an improvement in ASEX, IIEF scale, PANSS, and QLS scores, with no statistical differences between treatment groups in all sexual domains or in hormone levels (Nunes et al, 2013).…”

“…A number of studies have employed the ASEX scale to determine the incidence of treatment emergent sexual dysfunction during antipsychotic drug treatment (Atmaca, Kuloglu, & Tezcan, 2005;Byerly et al, 2004;Byerly, Nakonezny, & Rush, 2008;Hanssens et al, 2008;Kalkavoura et al, 2013;Konarzewska et al, 2009;Nakonezny, Byerly, & Rush, 2007;Nunes, Lacaz, Bressan, Nunes, & Mari, 2013;Uçok, Incesu, Aker, & Erkoç, 2007) (see Table 4).…”