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Table 1 List of acute mania trials of aripiprazole and their characteristics

From: Treatment of psychotic symptoms in bipolar disorder with aripiprazole monotherapy: a meta-analysis

Trial

Publication

Duration

COMP

PLC

Randomised, N

Efficacy sample, N

Safety sample, N

Results

     

AR

COMP

PLC

AR

COMP

PLC

AR

COMP

PLC

 

CN138-009

Keck et al., 2003 [27]

3 weeks

No

Yes

        

127

Agent > PLC

CN138-074/NCT00036101

Sachs et al., 2006 [28]

3 weeks

No

Yes

137

 

135

136

 

132

136

 

133

Agent > PLC

CN138-135/NCT00095511

Keck et al., 2009 [29]

12 weeks

Li

Yes

155

160

165

154

155

163

154

159

164

Agent = comparator > PLC

CN138-162/NCT00097266

Young et al., 2009 [30]

12 weeks

Hal

Yes

167

165

153

152

161

152

166

165

153

Agent = comparator > PLC

CN138-007

Unpublished

3 weeks

No

Yes

267

 

134

267 -

 

134 -

267 -

 

134 -

Agent = PLC

CN138-077/NCT00046384

Unpublished

3 weeks

No

Yes

29

 

27

      

No results

CN138008

Vieta et al., 2005 [32]

12 weeks

Hal

No

175

172

 

171

158

 

175

169

 

Agent > comparator

All RCTs

Total by groups

    

1,060

497

746

1,005

474

704

1,025

493

711

 

Total

      

2,303

  

2,183

  

2,229

 

Only RCTs with PANSS data

              

Total by groups

    

663

497

480

613

474

447

631

493

450

 

Total

      

1,640

  

1,534

  

1,574

 
  1. Dash indicates missing data. AR = aripiprazole; COMP = comparator; PANSS = Positive and Negative Syndrome Scale; PLC = placebo; RCT = randomised controlled trial.