Adjunctive lurasidone taken over a median of 126 days relieved depressive symptoms by nearly 50% for individuals with bipolar disorder who were experiencing syndromal depression, according to a study published in the Journal of Clinical Psychopharmacology.
The present study enrolled 61 outpatients being treated at the Stanford University Bipolar Disorders Clinic. Data analyzed were taken at the baseline visit, when lurasidone was initiated at a dose of 21.8 ± 6.2 mg/d, and during a final visit at a lurasidone dose of 55.6 ± 30.8 mg/d, which took place a median of 126 days later.
The participants were 63.9% female, with a mean age of 45.1 ± 14.0 years. Of the 61 participants 32 were bipolar type I, 26 were type II, and 3 were type not otherwise specified. The lurasidone trials were initiated during syndromal depression for 57.4% of participants, subsyndromal depression for 23.0%, and euthymia for 19.7%.
Most participants were instructed to increase their dosage of lurasidone by 20 mg a week to reach target doses of 40 to 80 mg/d. Participants were taking an average of 3.1 ± 1.4 additional prescription psychotropic medications at baseline.
After a median of 103 days, 77% of participants discontinued lurasidone (54.1% due to inadequate tolerability, 16.4% due to inadequate efficacy, and 6.6% due to other reasons). For participants who completed the trial, lurasidone decreased rates of syndromal depression by nearly one half, and more than doubled the rate of euthymia. The rate of subsyndromal depression did not alter.
The most common adverse events cited for discontinuation were akathisia (14.8%), somnolence/sedation (13.1%), weight gain (8.2%), and nausea (8.2%). Two of the 61 participants discontinued the trial due to hypomania.
Although lurasidone significantly relieved syndromal depression in 96.7% of participants, most of whom were treatment resistant, the 54.1% discontinuation rate due to adverse events suggests limitations in the drug’s tolerability.
The study was funded by Sunovion Pharmaceuticals.
Miller S, Do D, Gershon A, et al. Longer-term effectiveness and tolerability of adjunctive open lurasidone in patients with bipolar disorder [published online April 3, 2018]. J Clin Psychopharmacol. doi: 10.1097/JCP.0000000000000867