Add-on drug lumateperone boosts sexual function in patients with depression

Patients with major depressive disorder (MDD) and an inadequate response to standard antidepressants who received an add- on treatment with the drug lumateperone saw significantly improved sexual function, found a new study led by a University of Virginia School of Medicine researcher. 

In a study of 480 patients, significant improvements in sexual function were seen in patients who were randomized to receive a daily 42 mg dose of lumateperone added to their antidepressant therapy compared with patients whose additional treatment was a harmless placebo. Improvements were seen across multiple patient groups including those with baseline sexual dysfunction, women, younger and older adults as well as across various aspects of sexual functioning (desire, arousal, orgasm and pleasure). 

Approximately 68% of patients with major depressive disorder have sexual dysfunction, and the sexual side effects of antidepressant medications are a leading reason patients stop treatment.

Lead researcher Anita H. Clayton, MD, a psychiatrist at UVA Health, hailed the findings as an important step forward in the management of sexual dysfunction in patients with depression.

Link between depression and sexual function

Major depressive disorder affects approximately 21 million American adults, according to the Anxiety & Depression Association of America. As the researchers note in a paper outlining their study results, sexual dysfunction increases the risk for major depressive disorder, while major depressive disorder and its treatments are also a common cause of sexual dysfunction.

The researchers wanted to see if lumateperone – an atypical antipsychotic medication approved by the federal Food and Drug Administration to treat schizophrenia, bipolar depression and as an add-on treatment to antidepressant therapy for major depressive disorder – could improve sexual function in patients with MDD already receiving treatment with standard antidepressant medications, but with a less than 50% reduction in depressive symptoms. 

The researchers found that participants who received the add-on lumateperone saw significant improvements in depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and sexual function as measured by the Changes in Sexual Functioning Questionnaire (CSFQ-14) by the end of the 43-day treatment period. At the beginning of the trial, 82.5% had sexual dysfunction; by the end, more than a quarter reported regular sexual function. 

Women appeared to benefit more than men, but the researchers say more research is needed to verify that. Both sexes reported improvements in sexual pleasure and arousal.

In addition, study participants who did not have sexual dysfunction and received lumateperone did not report any worsening of their sexual function during the trial.

While MDD is associated with sexual dysfunction in 68% of patients, common antidepressants like selective serotonin reuptake inhibitors (SSRIs) also contribute to sexual dysfunction in approximately 70% of patients. So if an individual taking an SSRI doesn’t see a significant reduction in MDD symptoms, they have a higher combined risk of sexual dysfunction. In this study, depressive symptoms and sexual functioning improved in patients randomized to receive lumateperone as an add-on treatment when compared with a placebo. This was particularly true in women although both sexes had improvement in pleasure, sexual desire and interest. This medication, recently approved by the FDA as an add-on treatment when antidepressants alone have had a limited benefit in patients with MDD, improves depressive symptoms and is not associated with medication-induced sexual dysfunction. For this reason, this treatment option may be preferable for some individuals with an inadequate MDD response who wish to avoid sexual dysfunction as a medication side effect.” 

Anita H. Clayton, MD, psychiatrist at UVA Health

Findings published

Clayton and her team have published their findings in The Journal of Clinical Psychiatry. The research team who designed the plan to measure sexual function in the study and interpreted the results include Willie R. Earley, Susan G. Kozauer, Yifan Mo, John B. Edwards, Suresh Durgam and Clayton. The study was funded by Intra-Cellular Therapies. A full list of the authors’ disclosures is contained in the paper.