PHILADELPHIA — Latuda, an atypical antipsychotic currently intended for schizophrenia and bipolar I disorder, improved depressive symptoms and sexual functioning among individuals with major depressive disorder with mixed features, according to data presented here.
To determine the impact of baseline depression severity on treatment response, researchers randomly assigned individuals who met DSM-IV criteria for unipolar major depressive disorder and presented with several manic symptoms to 20 mg to 60 mg per day of Latuda (lurasidone, Sunovion Pharmaceuticals) (n = 109) or placebo (n = 100) for 6 weeks.
Overall, study participants had Montgomery-Asberg Depression Rating Scale scores of 26 and higher. Researchers classified participants into three groups of depression severity: moderately severe with MADRS scores from 26 to 30 (n = 59), markedly severe with MADRS scores from 31 to 35 (n = 95), and highly severe with MADRS scores of 36 or higher (n = 54).
From baseline to week 6, change in MADRS scores increased as baseline depression severity increased from moderate (P = .022) to marked (P = .001) to high (P < .0001).
Clinical Global Impression scores followed a similar trend for participants with moderate (P = .137), marked (P = .009) and high depression severity (P = .002), as did scores for mania, anxiety and functional disability.
Mean modal daily dose of lurasidone was similar among moderate (41.8 mg), marked (39.6 mg) and high severity (43.6) groups.
Researchers also examined the effect of lurasidone on sexual functioning. Study participants completed the Changes in Sexual Functioning Questionnaire (CSFQ) at baseline and week 6.
The mean CSFQ total scores at baseline were 35.4 for the lurasidone group and 34.1 for the placebo group.
Study participants who received lurasidone exhibited significantly improved CSFQ total scores, with an effect size of 0.28 (P < .05).
The CFSQ pleasure subscale scores also significantly improved.
Analysis indicated nonsignificant improvement in desire/frequency, desire/interest, arousal and orgasm subscales of CFSQ.
Differences in improvement in CFSQ total scores did not reach statistical significance at week 6 for women or for men.
Approximately 1.9% of the lurasidone group and 4.2% of the placebo group shifted from normal sexual functioning at baseline to abnormal functioning at study endpoint.
“Treatment with lurasidone significantly improved depressive symptoms in patients with a diagnosis of major depressive disorder with subthreshold hypomania. Modest but significant improvement in sexual function was also observed. Lurasidone treatment did not appear to be associated with treatment-emergent adverse effects on sexual function when compared with placebo,” the researchers concluded. – by Amanda Oldt
Nelson C, et al. Lurasidone for major depressive disorder with mixed features: Effect of baseline depression severity on clinical outcome. Presented at: Anxiety and Depression Association of America Conference; March 31-April 3, 2016; Philadelphia.
Tsai J, et al. Lurasidone treatment of major depression with mixed features: Effect on sexual function. Presented at: Anxiety and Depression Association of America Conference; March 31-April 3, 2016; Philadelphia.
Disclosure: The studies were supported by Sunovion Pharmaceuticals.