Lurasidone Linked to Improving Social Functioning for Schizophrenia

Credit: Unsplash

Lurasidone is linked to improving social functioning in patients with schizophrenia, a new study found.¹

“The current study is the first to document the effects of lurasidone compared to placebo on social functioning in the treatment of schizophrenia using the PANSS prosocial subscale,” wrote investigators, led by Led by Itaru Miura, MD, PhD, from the department of neuropsychiatry at Fukushima Medical University in Japan.

Schizophrenia, even at an early stage, is linked to social functioning impairment. A 2008 study found social functioning impairment in young people puts them at risk for schizophrenia.2 Deficits in social functioning are more pronounced for patients with longer illness durations.1

Social functioning impairment includes struggling to cope with social situations, social withdrawal, and social isolation. The level of social functioning impairment for patients with schizophrenia is linked to the extent of their recovery.

Although lurasidone was already approved for schizophrenia treatment in US adults and adolescents, little was known about the antipsychotic agent’s effects on social functioning in schizophrenia. Investigators sought to assess the effects of lurasidone on social functioning in schizophrenia over 6 and 12 weeks.

The team leveraged data from a multicenter, randomized, double-blind, placebo-controlled, parallel-group 6-week JEWEL study which started in May 2016 and ended in November 2018, as well as a subsequent 12-week open-label extension study to evaluate longer-term changes.

In total, the 6-week study included 478 patients with schizophrenia who were randomized to either lurasidone 40 mg/d (n = 245) or placebo (n = 233). Patients, aged 18 – 74 years with a mean age of 40 years, were recruited from 72 clinical sites in 5 countries including Japan, Ukraine, Russia, Romania, and Poland.

During the trial, participants had to discontinue the use of antipsychotics, antidepressants, mood stabilizers, and other psychotropics. However, patients could take antidepressant medications (except fluvoxamine) and mood stabilizers (except carbamazepine and oxcarbazepine) during the extension phase.

For patients participating in the 12-week open-label study, 146 patients received lurasidone and 141 received a placebo during the 6-week study and received flexibly dosed (40 – 80 mg/d) lurasidone during the 12-week extension phase.

The investigators used the 4-item Positive and Negative Syndrome Scale (PANSS) prosocial subscale to assess changes in social functioning. To be eligible for the study, patients at baseline had a total PANSS score of ≥ 80l.

Lurasidone significantly improved patients scores on the PANSS prosocial subscale compared to placebo (Cohen d effect size = 0.33; P < .01). The team observed significant differences from placebo at week 2 (P < .05), week 4 (P < .001), and week 5 (P < .01).

Patients who received lurasidone during the 6-week phase and the 12-week open-label phase continued to demonstrate decreases in scores on the 4-item PANSS prosocial subscale. For patients on lurasidone, the change in scores from baseline to week 6 was – 3.0 scale points, which improved to a -3.8 mean change from baseline to week 12 (26% further mean improvement from the end of the double-blind phase; n = 146)

Furthermore, patients who received placebo had a mean change of – 2.6 by week 6, which improved to – 3.5 from baseline to week 12 at the extension phase (66.7% further mean improvement from the end of the double-blind phase; n = 141).

Investigators noted the drug versus placebo effect size at week 6 (0.33) was similar to the effect of a meta-analysis of 10 placebo-controlled short-term studies (0.34) assessing the effects of other antipsychotic drugs on social functioning.

“Given this similarity in effect sizes, it is unlikely that the effects of lurasidone on social functioning are greater than such effects for other antipsychotics in the treatment of schizophrenia,” investigators wrote. “However, more head-to-head comparisons of lurasidone to other antipsychotics on improvements in social functioning, beyond the existing study comparing lurasidone and olanzapine, are needed to directly evaluate any potential differences among antipsychotics on this outcome.”

Limitations the investigators pointed out included the analyses being post hoc and needing confirmation in prospective trials, the extension phase being open-label with no placebo or control group, social functioning being evaluated using the PANSS subscale instead of a scale developed to specifically measure social impairment, not knowing the generalizability of other dosages of lurasidone, and not knowing the generalizability of the results to other types of patients and other durations due to inclusion criteria.

“In conclusion, among patients with an acute exacerbation of schizophrenia, lurasidone (40 mg/d) improves social functioning more than placebo over the course of 6 weeks of double-blind treatment, and such improvements continue during an additional 12 weeks of ongoing open-label flexible dose (40–80 mg/d) lurasidone treatment,” investigators wrote.

^References

1. ^{Miura I, Sano F, Sakaguchi R, Okamoto K, Maruyama H. Effect of Lurasidone on Social Functioning in Schizophrenia: Post Hoc Analysis of the JEWEL Study. J Clin Psychiatry. 2024;85(1):23m14881. Published 2024 Jan 31. doi:10.4088/JCP.23m14881}
2. ^{Shim G, Kang DH, Chung YS, Yoo SY, Shin NY, Kwon JS. Social functioning deficits in young people at risk for schizophrenia. Aust N Z J Psychiatry. 2008;42(8):678-685. doi:10.1080/00048670802203459}