Additional file 3: Table S3: Characteristics of the participants in the trials and interventions involved and record of responses

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Additional file 3: Table S3: Characteristics of the participants in the trials and interventions involved and record of responses

Characteristics of the participants in the trials and interventions involved

Study ID Coun try

Sam ple size

Condition

Interventi on (delivery)

Leng th Doses

Gend er (%

male )

Age (mea n (sd) years )

Registry ID

Publica tion lead author

(date publish

ed)

Trial regist

er resul

ts poste

d

Clini cal stud

y repo

rt (full)

RIS-USA-72 USA 246 Schizophr enia

Risperidon e (oral)

28 days

4, 8

mg 79%

Medi an:

38.5 (19- 65)

NA NA NA Yes^*

RIS-BIM-301 USA 169 Bipolar disorder

Risperidon e (oral)

3 week

s

0.5- 2.5 or

3-6 mg

49%

13 (10-

17)

NCT00076 115

Haas

2009 No Yes

RIS-SCH-302 Greec

e 160 Schizophr enia

Risperidon e (oral)

6 week

s

1-3 or 4-6 mg

64% 15.6 (1.3)

NCT00088 075

Haas

2009 No Yes

RIS-BIP-302 USA 275 Bipolar disorder

Risperidon e (intramusc

ular injection)

52 week

s

1-2

mg 71% 40

(11.8)

NCT00094 926

Macfad den 2009(1), 2009(2), 2011

No Yes

RISBIM3003 Spain 559 Bipolar disorder

ular injection)

24 mont

hs

25mg 49% 39

(11.8)

NCT00132 678

Quiroz

2010 Yes Yes

RIS-USA-121 USA 458 Schizophr enia

ular injection)

12 week

s

25, 50, 75

mg

>

65%

>

36.2 (9.5)

NCT00253 136

Kane

2003 No Yes

RIS-USA-102 USA 158 Bipolar disorder

Risperidon e (oral)

3 week

s

2, 4, 6, 12 mg

50%

41 (18-

61)

NCT00253 149

Sachs

2002 No Yes

RIS-INT-69 Russi

a 439 Bipolar

disorder

ular injection)

12 week

s

1-6

mg 53.9 41.3

(13.1)

NCT00253 162

Smulevi

ch 2005 No Yes

RIS-USA-239 USA 267 Bipolar disorder

Risperidon e (oral)

3 week

s

1-6

mg 53% 38.1

(11.9)

NCT00257 075

Hirschfe

ld 2004 No Yes

RISBMN3001 Spain 585 Bipolar disorder

ular injection)

18 mont

hs 25,

50mg 48% 36.9 (11.4)

NCT00391 222

Vieta

2012 Yes Yes

RIS-SCP-402 USA 381 Schizophr enia

Risperidon e (oral)

6 week

s

4, 6

mg 69% 34.7

(9.6)

NCT00061 802

Gharaba

wi 2006 No Yes

R076477-

SCH-304 USA 444 Schizophr

enia

Paliperido ne (oral)

6 week

s

6, 12

mg 74%

41.6 (10.6

7)

NCT00077 714

Marder

2007 No Yes

R076477- SCH-303

USA 628 Schizophr enia

6 week

6, 9, 12 mg

52% 37.1 (10.9)

NCT00078 039

Kane 2007

No Yes

(2)

s R076477-

SCH-302

Greec

24 week

s

3-12

mgs 27% 70 NCT00085

748

Tzimos

2008 No Yes

R076477-

enia

14 week

s

3-15

mgs 56% 39

(10.7)

NCT00086 320

Kramer

2007 No Yes

R076477- SCH-1010

Franc

e 36 Schizophr

enia

14

days 9 mg 67% 32.2

(7.32)

NCT00105 326

Luthring

er 2007 No Yes

R076477-

BIM-3001 USA 469 Acute

mania

3 week

s

3, 6, or 12mg

s

55% 39

(11)

NCT00299 715

Berwaer

ts 2012 No Yes

R076477-

BIM-3003 USA 300 Bipolar 1 disorder

6 week

s

3-12

mg 57% 40

(10.9)

NCT00309 686

Berwaer

ts 2011 No Yes

R076477-

BIM-3002 Spain 493 Bipolar 1 disorder

12 week

s

3-12

mg 58% 40

(11.3)

NCT00309 699

Vieta

2010 No Yes

R076477SCH

3015 USA 399 Schizophr

enia

6 week

s

9, 12

mgs 70% 35.7

(11.6)

NCT00334 126

Canuso

2009 No Yes

R076477SCA

enia

6 week

s

6-12 mgs

66.7 0%

38.1 (10)

NCT00397 033

Canuso

2010 Yes Yes

R076477SCA

enia

6 week

s

3-12 mg

67.0 0%

31.2 (9.9)

NCT00412 373

Canuso

2010 Yes Yes

R076477-

enia

52 week

s

Flexibl e: 3- 15mg;

9 mg startin

g

66% 35.8 (9.83)

NCT00645 307

Kramer

2010 No Yes

R076477- SCH-702

Greec

6 week

s

3-12

mgs 27% 70 NCT00752

427

Tzimos

2008 No Yes

R092670-

enia

Paliperido ne palmitate (intramusc

ular injection)

9 week

s

50, 100 mg eq.

62% 40

(10.5)

NCT00074 477

Kramer

2010 No Yes

R092670PSY

enia

ular injection)

13 week

s

25, 50, 100 mg eq

67% 40.8 (11.3)

NCT00101 634

Nasralla

h 2010 No Yes

R092670PSY

enia

ular injection)

24 week

s

25, 50, 100 mg eq

55% 40

(11.5)

NCT00111 189

Hough

2010 No Yes

R092670PSY

enia

ular injection)

13 week

s

25, 100, 150 mg eq

69% 40

(10.8)

NCT00210 548

Gopal

2010 No Yes

R092670PSY 3007

USA 652 Schizophr enia

13 week

s

25, 100, 150 mg eq

67% 39 NCT00590

577

Pandina 2010

Yes Yes

(3)

ular injection)

R092670SCA

enia

ular injection)

15 mont

hs

Flexab le: 25 - 100 mg

51%

38.6 (19- 66)

NCT01193

153 Fu 2015 Yes Yes

PALM-JPN-4 Japan 323 Schizophr enia

ular injection)

13 week

s

75, 100, 150 mg ep.

57%

44.8 (12.9

9)

NCT01299 389

Akihide

2013 Yes Yes

R092670PSY

enia

ular injection)

12 week

s

50, 75, 100 or

150 mg eq

75%

37.8 (11.0

1)

NCT01529 515

Berwaer

ts 2015 Yes Yes

R076477PSZ

enia

6 week

s

1.5, 3,

6 mgs 59% 15.4 (1.53)

NCT00518 323

Singh

2011 Yes Yes

R076477-

SCH-3041 China 135 Schizophr enia

24 week

s

3-12

mg 41%

31.7 (10.9

0)

NCT01662 310

Rui

2014 Yes Yes

R076477- SCH-305

USA (most

ly)

618 Schizophr enia

6 week

s

3,9,15

mgs 68% 36.8

(10.6)

NCT00083 668

Davidso

n 2007 No Yes

*Not full report but main content of the core report was available for meta-analysis; NA: not applicable; SD: standard deviation.

Record of responses from data custodians and regulators following requests for data Data

custodia n

Response

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YODA Dear Investigator,

Your inquiry about data availability (NCT01086748, NCT00694707, and NCT00272584) has been reviewed by the YODA Project. The Data Partner has confirmed that these data cannot be made available to external investigators for the following reason:

1. The Data Partner is not the clinical trial sponsor.

Please refer to the YODA Project Policy and Procedures documentation for a more thorough explanation of the circumstances which may result in a Data Partner being unable to make clinical research data available to external investigators. Please note that Johnson & Johnson and SI-BONE are the only Data Partners currently making clinical trial data available through the YODA Project. As such, the YODA Project will not be able to provide data owned by other clinical trial sponsors. Please verify the trial sponsor at www.ClinicalTrials.gov prior to submitting an inquiry.

We encourage you to regularly check the list of currently available data (available here) in case new data become available that are relevant to your research.

Thank you again for your inquiry and interest in this project. If you have any questions at any point, please contact the YODA Project at yodap@yale.edu.

Best regards, The YODA Project YODA Dear Investigator,

Your inquiry about data availability (NCT00061802) has been reviewed by the YODA Project. The Data Partner has confirmed that this study can be made available for sharing.

Please note that only clinical documents are available – participant-level data is not available for this study. The Trial List has been updated to reflect this newly available study.

If you are still interested in these data, please submit a formal research request on the YODA Project Data Request Website. More information about what is required to submit a request can be found here.

Thank you again for your inquiry and interest in this project. If you have any questions at any point, please contact the YODA Project at yodap@yale.edu.

Best regards,

The YODA Project

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YODA Dear Investigator,

The remaining studies from your inquiry have been reviewed by the YODA Project:

• PMID: 18545059 – This is a post hoc analyses of pooled studies

• PMID: 19552963 – This is a post hoc analyses of pooled studies

• PMID: 19560322 – This is a post hoc analyses of pooled studies

• PMID: 20199482 – This is a post hoc analyses of pooled studies

Thank you again for your inquiry and interest in this project. If you have any questions at any point, please email us at yodap@yale.edu.

Best regards, The YODA Project

EMA Response had to be removed as it contained personal confidential information. But two CSRs were retrieved from the European Medicines Agency Clinical Data online portal:

Additional file 3: Table S3: Characteristics of the participants in the trials and interventions involved and record of responses