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. 2010 Oct 27;36(2):375–389. doi: 10.1038/npp.2010.192

Table 2. Characteristics of Included Randomized, Monotherapy Trials Comparing Two Active Drugs for Treatment of Acute Mania (N=27).

Design Sitesa Drugs (Rx)
 Patients (n, ITT)
 Mania rating/trial weeks Completers (%)
 Baseline mania (mean±SD)
 Severity (% of max)
 Mania score change (mean±SD)
 Change (%)
 Response (%)
 Source (references)
    Rx1 Rx2 Rx1 Rx2   Rx1 Rx2 Rx1 Rx2 Rx1 Rx2 Rx1 Rx2 Rx1 Rx2 Rx1 Rx2  
RDB 1 Li OLZ 15 15 MRS/4 80 93.3 31.6 31.7 60.8 61 18.4 21.5 58.2 67.8 ––– ––– Berk et al, 1999b
RDB 9 Li VPA 35 67 MRS/3 39 52 27.1±7.4 27.2±7.6 52 52.2 9.3±15.8 9.2±12 34.3 34 48.6 47.8 Bowden et al, 1994c
RDB 38 Li QTP 98 107 YMRS/3 85.7 90.6 33.3±7.1 32.7±6.5 55.5 62.9 15.2±15.4 14.6±15.7 45.7 44.7 53.1 53.3 Bowden et al, 2005c
RO 49 Li VPA 145 148 YMRS/12 (3)d 74.8 73.2 30.6±6.2 31±6.9 51 51.7 20.6±11.5d 21±12.8d 67.3d 67.7d 37.9 47.3 Bowden et al, 2008
RDB 1 Li VPA 13 14 MRS/3 76.9 85.7 43.4±20.3 42.9±12.3 83.5 82.5 33.2±14.6 25.8±16.6 76.5 48.8 92.3 64.3 Freeman et al, 1992
RDB 47 Li LTG 36 84 MRS/3 44.4 62.4 26.2±5.9 26.4±6.5 50.4 50.8 10.7±11.6 9.3±10.9 40.8 35.2 41.7 44.1 Goldsmith et al, 2003c
RDB 1 Li LTG 15 15 MRS/4 80 86.7 31.6 34.4 60.8 66.2 18.4 20.1 58.2 58.4 60 53.3 Ichim et al, 2000b
RDB 2 VPA OxCBZ 30 30 YMRS/12 (3)e — — 34.6±6.5 33.8±5.4 57.7 56.3 10±6.6 9.9±5 28.8 29.4 90e 80e Kakkar et al, 2009
RDB 16 OLZ HAL 104 20 YMRS/6 (3)e — — — — — — 12.6 — — — 44.2e 20e Katagiri et al, 2010c
RDB 42 Li APZ 155 154 YMRS/3 49 47 29.4±5.9 28.5±5.6 49 46.7 12±10.3 12.6±10.4 40.9 44.4 45.8 46.8 Keck et al, 2009c
RDB 40 Li TPM 113 215 YMRS/3 74 70 30.1±7.4 30.5±7.5 50.2 50.8 12.9±11.8 6±12.1 42.9 19.7 46f 27f Kushner et al, 2006c
RDB 40 Li TPM 114 115 YMRS/3 82 87 30.7±7.5 30.8±6.8 51.2 51.3 13.8±11.9 8.2±11.8 45 26.6 46f 27f Kushner et al, 2006c
RDB 2 Li QTP 77 77 YMRS/4 80.5 94.8 29.8±5.7 29.3±5.8 49.7 48.8 — — — — 59.7 77.9 Li et al, 2008
RSB 1 VPA HAL 21 15 YMRS/1 100 100 36.1±11 37.2±8.8 60.2 62 15.4±11 12.9±10.7 42.7 34.7 47.6 33.3 McElroy et al, 1996
RDB 49 QTP HAL 101 98 YMRS/3 64.7 77.8 34±6.1 32.3±6 56.7 53.8 12.3±13.5 15.7±13.4 36.2 48.6 42.6 56.1 McIntyre et al, 2005c
RDB 70 OLZ ASN 203 183 YMRS/3 78.5 67 29.7±6.6 29.4±6.7 49.5 49 16.1±11 14.2±11.5 54.2 48.3 54.7 42.6 McIntyre et al, 2009ac
RDB 64 OLZ ASN 188 189 YMRS/3 79.6 62.9 28.6±5.9 28.3±5.5 47.7 47.2 13.9±10.7 13.1±11.3 48.6 46.3 50 42.3 McIntyre et al. 2009bc
RDB 7 Li OLZ 71 69 YMRS/4 78.9 91.3 32.4±7.2 34±6.8 54 56.7 20.2±11.4 24.6±11.3 62.2 72.4 73.2 87 Niufan et al, 2008
RDB 30 OLZ RSP 164 164 YMRS/3 78.7 67 26.6±5 26.7±5 44.3 44.5 15 16.6 56.5 62.3 62.1 59.5 Perlis et al, 2006a
RO 21 Li VPA 135 122 YMRS/12 (3)d 94.2 93.8 24.4±5 24.1±5.3 40.7 40.2 15.8±5.8d 17.3±9.4d 64.8d 71.8d 54 54 Sanofi-Aventis, 2007
RDB 1 Li RSP 15 15 YMRS/4 93.3 86.7 28.4 28.6 47.3 47.7 15.7 12.4 55.3 43.4 ––– ––– Segal et al, 1998g
RDB 1 Li HAL 15 15 YMRS/4 93.3 80 28.4 24.8 47.3 41.3 15.7 10.2 55.3 41.1 ––– ––– Segal et al, 1998g
RDB 1 Li CBZ 24 24 YMRS/8 42.3 65.4 30.3 30.9 50.5 51.5 9.7 8.5 32 27.5 33.3h 33.3h Small et al, 1991
RDB 20 RSP HAL 153 144 YMRS/3 89 90 32.1±6.9 31.3±6.5 53.5 52.2 15.1±10.3 13.9±10.3 47 44.4 47.7 47.2 Smulevich et al, 2005c
RDB 48 VPA OLZ 123 125 YMRS/3 64.3 68.8 27.9±6.6 27.4±5.2 46.5 45.7 10.4±10.4 13.4±8.8 37.3 48.9 42.3 54.4 Tohen et al, 2002
RDB 58 OLZ HAL 231 213 YMRS/6 (12) 70.9 64.4 31.1±7.6 30.6±7.7 51.8 51 — — — — 55i 62i Tohen et al, 2003
RDB 42 VPA OLZ 186 201 YMRS/3 75.1 74 23.9±2.8 23.8±2.8 39.8 39.7 8.2±8.5 9.4±8.5 34.3 39.5 40.3 40.8 Tohen et al, 2008c
RDB 76 APZ HAL 173 164 YMRS/3 (12) 76.6 55.2 31.1±6.6 31.5±7.9 51.8 52.5 15.7 15.7 50.5 49.8 50.9 42.6 Vieta et al, 2005
RDB 33 HAL ZPS 170 176 MRS/3 71.3 66.9 30.7±7.4 29.6±8 59 56.9 15.9±10.6 10.4±11.1 51.9 35.2 54.7 36.9 Vieta et al, 2010ac
RDB 52 QTP PPD 192 190 YMRS/3 79 82 27.6±5.1 27.3±5 46 45.5 11.7±9.3 13.2±8.7 42.4 48.4 49 44.2 Vieta et al, 2010bc
RDB 59 APZ HAL 166 161 YMRS/3 75 73 28±5.8 27.6±5.6 46.7 46 12±10.3 12.8±10.2 42.8 46.5 47 49.7 Young et al, 2009c
RDB 21 VPA OLZ 60 55 MRS/3 62 68 30.8 32.3 59.2 62.1 14.8 17.2 48.1 53.3 — — Zajecka et al, 2002

Abbreviations: APZ, aripiprazole; ASN, asenapine; CBZ, carbamazepine; CGI, clinical global impressions scale; HAL, haloperidol; ITT, intent to treat; Li, lithium; MRS, mania rating scale; OLZ, olanzapine; OxCBZ, oxcarbazepine; PPD, paliperidone; QTP, quetiapine; RDB, randomized double blind; RSP, risperidone; RO, randomized open; Rx, treated with study drug; TPM, topiramate; VPA, valproate; YMRS, Young mania rating scale; ZPS, ziprasidone.

a

In studies, in which actual site numbers are not reported, they are estimated as twice the reported number of countries.

b

Lithium arm from the same study with two active controls reported separately.

c

Indicates results from placebo-controlled studies with two active treatment arms.

d

Response rate is at 3 weeks; mania score change is at 12 weeks.

e

Mania score change results are at 3 weeks end point; response results actually indicates rate of remission (defined as YMRS score of ⩽12) at 6, and 12 weeks end point, respectively.

f

Indicates pooled results.

g

Same study reported twice as it has two comparisons between three drugs.

h

Response is defined as moderate improvement with CGI.

i

Response is defined as ⩾70% improvement with YMRS.

Studies listed in alphabetic order of authors' names.

Ratings and changes are based on mania ratings by YMRS or MRS.