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Table 3 Mean changes from baseline in the open-label period of the randomized withdrawal study

From: Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program

  Nonrandomized Randomized
n = 96 n = 20
Measures, mean (SD) Baseline Changea Baseline Changea
Pain, range 0-10 6.5 (1.4) −1.1 (1.6) 6.1 (1.3) −3.3 (1.0)
PGIS, range 1-7 4.0 (0.8) −0.4 (1.0) 4.0 (0.8) −1.0 (1.0)
PedsQL-Generic Core Scales, range 0-100 55.6 (14.8) 4.5 (13.0) 54.2 (11.4) 10.9 (10.9)
PedsQL-Multidimensional Fatigue Scale, range 0-100 46.1 (17.6) 5.8 (15.3) 41.3 (13.3) 13.3 (12.1)
MASC, range 0-117 45.1 (16.5) −2.4 (12.2) 46.1 (13.4) −5.4 (13.2)
CDI, range 0-54b 11.9 (7.1) −1.2 (5.0) 11.1 (5.5) −2.4 (4.9)
  1. aChanges are based on end-of-treatment values. Negative changes represent mean improvements in pain, PGIS, MASC, and CDI scores; positive values represent mean improvements in PedsQL scores. For pain, data were based on electronic entries from Week 7 (i.e., the last week prior to randomization). For other measures, data were based on last available open-label assessments, including those from patients who prematurely discontinued the study
  2. bPrimarily used in this study as a safety assessment to monitor changes in depressive symptoms
  3. CDI = Children’s Depression Inventory, MASC = Multidimensional Anxiety Scale, PGIS = Patient Global Impression of Severity, PedsQL = Pediatric Quality of Life Inventory-Teen Report, SD = standard deviation