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

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

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

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
^aCalabrese et al. [21]
^bThase et al. [23]
^cYoung et al. [24]
^dMcElroy et al. [22]
^eSuppes et al. [25]

ISSN: 1744-859X