A growing body of evidence suggests that manic symptoms below the threshold for hypomania (mixed features) are common in individuals with major depressive disorder. Little is known of the best treatment options for this form of depression, but some clinical trials have suggested that standard antidepressants may be ineffective for this condition and associated with potential treatment-related complications, including suicidal ideation and behavior, manic switch, agitation, and impulsivity.
For the current study, researchers from Stanford University and Sunovion Pharmaceuticals randomly assigned patients aged 18-75 with a major depressive disorder (based on DSM-IV-TR criteria) who also reported two to three manic symptoms for at least two weeks prior to screening to take lurasidone (20-60 mg) or placebo daily for six weeks.
Lurasidone significantly improved depressive symptoms compared with placebo, as indicated by changes from baseline in Montgomery-Åsberg Depression Rating Scale score and the Clinical Global Impressions severity subscale score. Manic symptoms were also significantly improved in the lurasidone group, and treatment with lurasidone was associated with significant improvement both in anxiety symptoms and in patient-reported functional impairment. Nausea (6.4% and 2.0% in the lurasidone and placebo groups, respectively) and somnolence (5.5% and 1.0%) were the most common adverse events reported by the study participants.
“There is a pressing need for evidence-based treatments of major depressive disorder presenting with subthreshold hypomanic symptoms (mixed features), especially given its complex course and associated morbidity,” the study authors wrote. “Treatment with lurasidone was well tolerated, with a favorable benefit-risk profile in this difficult-to-treat clinical population. Further investigation is needed to determine whether these findings are applicable to other agents in the atypical antipsychotic class.”
For related information on lurasidone’s effectiveness in treating bipolar I depression, see the Psychiatric News article “Data Released Backing Lurasidone’s New Indication.”