Lurasidone in the Treatment of Sleep Disturbance Associated With Bipolar Depression: Post-hoc Analysis of a Placebo-Controlled Trial Followed by a Long-Term Extension Study
This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.
BACKGROUND: Sleep disturbance is a cardinal symptom of depression, and has a significant impact on treatment outcomes and functioning. This post-hoc analysis evaluated the effect of lurasidone on sleep disturbance in patients with bipolar depression.
METHODS: Outpatients meeting DSM-IV-TR criteria for bipolar I depression received once-daily lurasidone 20-60 mg/d, 80-120 mg/d, or placebo in a 6-week acute treatment study, followed by lurasidone 20-120 mg/d in a 6-month, open-label extension study. Sleep disturbance was assessed using the QIDS-SR16 sleep domain score. Recovery was defined as meeting criteria for combined symptomatic (MADRS ≤12) and functional remission (all SDS domain scores ≤3) at both months 3 and 6 of the extension study.
RESULTS: Improvement in sleep disturbance, as assessed by mean change from baseline to week 6 in QIDS-SR16 sleep domain score, was significantly greater for lurasidone 80-120 mg/d compared with placebo (p<0.05). Numeric improvement was observed favoring lurasidone 20-60 mg/d vs. placebo (p=0.059). Acute improvement in sleep disturbance (reduction in QIDS-SR16 sleep domain score from baseline to week-6) was significantly associated with greater likelihood of attaining combined symptomatic and functional remission at week 6 in the acute study (p<0.05). Improvement in sleep disturbance at week 6 also significantly predicted sustained recovery in the 6-month continuation study (p<0.05).
DISCUSSION: In this randomized double-blind, placebo-controlled study, once-daily lurasidone 20-60 mg/d or 80-120 mg/d significantly reduced sleep disturbance, assessed using the QIDS-SR16 sleep domain score, in patients with bipolar depression. Improvement in sleep disturbance at week 6 increased the likelihood of longer-term recovery