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Table 1 Randomised controlled trials (RCTs) assessing the usefulness of aripiprazole in bipolar disorder

From: Efficacy and safety of aripiprazole in the treatment of bipolar disorder: a systematic review

       

Patients (n)

 

Trial no.

Publication

Target

Duration

Comparator

Placebo

Add on

Agent

Comparator

Placebo

Comments

CN138-009

Keck et al., 2003 [68]

Mania

3 weeks

No

Yes

No

130

 

132

Agent > placebo

CN138-074/NCT00036101

Sachs et al., 2006 [69]

Mania

3 weeks

No

Yes

No

137

 

135

Agent > placebo

CN138-135/NCT00095511

Keck et al., 2009 [70]

Mania

12 weeks

Lithium

Yes

No

155

160

165

Agent = comparator > placebo

CN138-162/NCT00097266

Young et al., 2009 [71]

Mania

12 weeks

Haloperidol

Yes

No

167

165

153

Agent = comparator > placebo

CN138-007

unpublished

Mania

3 weeks

No

Yes

No

267

 

134

Agent = placebo

CN138-013

Zimbroff et al., 2007 [74]

Mania

24 h

Lorazepam

Yes

No

156

70

75

Agent = comparator > placebo

CN138-077/NCT00046384

Unpublished

Mania

3 weeks

No

Yes

No

29

 

27

No results

CN138008

Vieta et al., 2005 [72]

Mania

12 weeks

Haloperidol

No

No

175

172

 

Agent > comparator

CN138-134/NCT00257972

Vieta et al., 2008 [73]

Mania

6 weeks

No

Yes

Lithium/Vpx

253

 

131

Agent > placebo

CN138-096/NCT00080314

Thase et al., 2008 [75]

Bipolar depression

8 weeks

No

Yes

No

186

 

188

Agent = placebo

CN138-146/NCT00094432

Thase et al., 2008 [75]

Bipolar depression

8 weeks

No

Yes

No

187

 

188

Agent = placebo

CN138-010/NCT00036348

Keck et al., 2006/7 [76, 77]; Muzina et al., 2008 [78]

Maintenance

26 to 100 weeks

No

Yes

No

77

 

83

Agent > placebo

CN138008

Unpublished

Maintenance

14 weeks

Haloperidol

No

No

30

9

 

No results

CN138-135/NCT00095511

Unpublished

Maintenance

40 weeks

Lithium

No

No

56

38

 

Agent = comparator

  1. Vpx: Valproex