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International Journal of Bipolar Disorders

Table 1 Baseline demographic and clinical characteristics

From: Anxiety, irritability, and agitation as indicators of bipolar mania with depressive symptoms: a post hoc analysis of two clinical trials

 

Asenapine (n = 372)

Placebo (n = 197)

Olanzapine (n = 391)

Total (N = 960)

Male, n (%)

203 (54.6)

98 (49.7)

230 (58.8)

531 (55.3)

Age (years), median (range)

40 (18–76)

39 (18–69)

39 (18–67)

39 (18–76)

Unemployed, n (%)

270 (72.6)

139 (70.6)

285 (72.9)

694 (72.3)

DSM-IV BD-I diagnosis, n (%)

 Manic episode

265 (71.2)

131 (66.5)

269 (68.8)

665 (69.3)

 Mixed episode

107 (28.8)

66 (33.5)

122 (31.2)

295 (30.7)

YMRS total scorea, mean (SD)

28.8 (6.2)

28.7 (6.2)

29.2 (6.3)

28.9 (6.2)

MADRS total scorea, mean (SD)

10.8 (7.0)

12.4 (7.8)

11.3 (7.3)

11.3 (7.3)

CGI-BP mania severity scorea, mean (SD)

4.7 (0.8)

4.6 (0.8)

4.6 (0.8)

4.6 (0.8)

CGI-BP depression severity scorea, mean (SD)

2.0 (1.2)

2.2 (1.3)

2.1 (1.3)

2.1 (1.3)

Number of depressive symptomsb, n (%)

 0–2

201 (54.0)

100 (50.8)

205 (52.4)

506 (52.7)

 3 or more

171 (46.0)

97 (49.2)

186 (47.6)

454 (47.3)

Severity of depressive symptoms, n (%)

 MADRS Total score <20

328 (88.2)

164 (83.2)

338 (86.4)

830 (86.5)

 MADRS Total score ≥20

44 (11.8)

33 (16.8)

53 (13.6)

130 (13.5)

Anxietyc, n (%)

 Absent or minimal

144 (38.7)

73 (37.1)

150 (38.4)

367 (38.2)

 Present

227 (61.0)

124 (62.9)

238 (60.9)

589 (61.4)

 Not rated

1 (0.3)

0 (0.0)

3 (0.8)

4 (0.4)

Irritabilityd, n (%)

 Absent or low

150 (40.3)

65 (33.0)

134 (34.3)

349 (36.4)

 Present

218 (58.6)

128 (65.0)

253 (64.7)

599 (62.4)

 Not rated

4 (1.1)

4 (2.0)

4 (1.0)

12 (1.3)

Agitatione, n (%)

 Absent or low

83 (22.3)

48 (24.4)

84 (21.5)

215 (22.4)

 Present

285 (76.6)

145 (73.6)

303 (77.5)

733 (76.4)

 Not rated

4 (1.1)

4 (2.0)

4 (1.0)

12 (1.3)

Severe AIAf, n (%)

 Not present

247 (66.4)

123 (62.4)

248 (63.4)

618 (64.4)

 Present

120 (32.3)

70 (35.5)

136 (34.8)

326 (34.0)

 One or more symptom not rated

5 (1.3)

4 (2.0)

7 (1.8)

16 (1.7)

  1. AIA, anxiety, irritability, and agitation; BD-I, bipolar I disorder; CGI-BP, Clinical Global Impressions-Bipolar version; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; MADRS, Montgomery–Åsberg Depression Rating Scale; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation; YMRS, Young Mania Rating Scale
  2. aFor patients missing a value at baseline, the value was used from the screening visit
  3. bBased on the number of individual MADRS items with a score of ≥1
  4. cBased on the PANSS anxiety item: ‘absent or minimal’ indicates a score of ≤2; ‘present’ indicates a score of ≥3
  5. dBased on the YMRS irritability item: ‘absent or low’ indicates a score of ≤3; ‘present’ indicates a score of ≥4
  6. eBased on the YMRS increased motor activity–energy item: ‘absent or low’ indicates a score of ≤2; ‘present’ indicates a score of ≥3
  7. fMeeting the above criteria for all three AIA symptoms
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