Skip to main content

Table 4 Mean change (SD) from long-term baseline to LOCF endpoint in efficacy measures

From: Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52 week open label study

Measure Most recent or current episode of bipolar I disorder
Depressed episode Non-Depressed episode (n = 81)
PBO to LUR (n = 41) LUR to LUR (n = 76)
Mean (SD) Mean (SD) Mean (SD)
MADRS − 2.0 (14.7) 1.4 (12.9) 2.5 (10.9)
YMRS − 0.6 (3.4) 0.2 (3.6) − 4.8 (9.0)
CGI-BP-S overall − 0.39 (1.60) 0.12 (1.43) − 0.14 (1.66)
CGI-BP-S depression − 0.32 (1.64) 0.13 (1.58) 0.38 (1.53)
CGI-BP-S mania − 0.07 (0.52) 0.03 (0.73) − 0.86 (1.43)
HAM-A† − 1.1 (8.5) − 0.3 (8.9) 0.9 (6.2)
SDS# − 0.4 (10.7) 0.8 (9.7) − 0.9 (9.9)
  1. Number of patients: All = 197, PBO to LUR = 41, LUR to LUR = 75, Non-Depressed = 81
  2. #Number of patients: All = 177, PBO to LUR = 38, LUR to LUR = 69, Non-Depressed = 70
  3. PBO to LUR = received placebo during prior 6 week trial followed by lurasidone (flexibly dosed 20 to 120 mg/day) in 52 week long-term trial
  4. LUR to LUR = received lurasidone (flexibly dosed at either 20–60 or 80–120 mg/day) during prior 6 week trial followed by lurasidone (flexibly dosed 20–120 mg/day) in 52 week long-term trial
  5. CGI-BP-S Clinical Global Impression Bipolar Version Severity of illness score, HAM-A Hamilton Rating Scale for Anxiety total score, LUR lurasidone, MADRS Montgomery-Åsberg Depression Rating Scale, PBO placebo, SD Standard Deviation, SDS Sheehan Disability Scale, YMRS Young Mania Rating Scale