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Table 1 Overview of five acute bipolar depression studies of quetiapine IR and XR

From: Bipolar II compared with bipolar I disorder: baseline characteristics and treatment response to quetiapine in a pooled analysis of five placebo-controlled clinical trials of acute bipolar depression

Study name (Trial ID number/
NCT number)
Patient population Design Treatments Efficacy measures
Quetiapine IR
 BOLDER I (5077US/0049/NCT00060489)a
 BOLDER II (D1447C00135/NCT00083954)b
N = 542 (BOLDER I)
N = 509 (BOLDER II)
8-week
Double-blind, fixed-dose, parallel-group
Identical study design to EMBOLDEN I and II
Quetiapine 300 mg/day or 600 mg/day
Placebo
MADRS (primary)
HAM-D
CGI-S
CGI-C
PSQI (BOLDER I)
SDS (BOLDER II)
Q-LES-Q
 EMBOLDEN I (D1447C00001)c
 EMBOLDEN II (D1447C00134/NCT00119652)d
N = 802 (EMBOLDEN I)
N = 740 (EMBOLDEN II)
8-week (acute phase)
Double-blind, fixed-dose, parallel-group
Identical study design to BOLDER I and II
Quetiapine 300 mg/day or 600 mg/day
Lithium 600–1800 mg/day (EMBOLDEN I)
Paroxetine 20 mg/day (EMBOLDEN II)
Placebo
MADRS (primary)
HAM-D
CGI-BP-S
CGI-BP-C
HAM-A
SDS
Q-LES-Q (EMBOLDEN II)
MOS-Cog (EMBOLDEN I)
Quetiapine XR
 002 XR (D144CC00002/NCT00422214)e N = 280 8-week (acute phase)
Double-blind, parallel-group
Quetiapine XR 300 mg/day
Placebo
MADRS (primary)
CGI-BP-C
CGI-BP-S
  1. CGI-(BP)-S clinical global impression-(bipolar)-severity, CGI-(BP)-C clinical global impression-bipolar-change, HAM-D Hamilton depression rating scale, HAM-A Hamilton rating scale for anxiety, MADRS Montgomery–Åsberg depression rating scale, MOS-Cog Medical Outcomes Study Cognitive Scale, PSQI Pittsburgh Sleep Quality Index, Q-LES-Q Quality of Life Enjoyment and Satisfaction Questionnaire, SDS Sheehan Disability Scale
  2. aCalabrese et al. [21]
  3. bThase et al. [23]
  4. cYoung et al. [24]
  5. dMcElroy et al. [22]
  6. eSuppes et al. [25]