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International Journal of Bipolar Disorders

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
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