corner
Healthy Skepticism
Join us to help reduce harm from misleading health information.
Increase font size   Decrease font size   Print-friendly view   Print
Register Log in

Healthy Skepticism International News

February 2010

Trials of newer antidepressants for depressed children and/or adolescents

by Peter R Mansfield and Jon Jureidini

Peter summarised the results of these trials in March 2007 and Jon updated the summary in November 2008.

This page was published earlier in 2008 in our old website at: http://www.healthyskepticism.org/documents/documents/trialstable.php

Drug

Name of trial if known to FDA in 2004<1>

Number of subjects D=drug, P=placebo

Result classification according to Moreno et al 2007<2>

Result classification according to Mansfield 2007, Jureidini 2008

Reason for disagreeing with Moreno et al

Withdrawal due to Adverse Event

Published trials

Drug

placebo

Fluoxetine<3>

HCCJ

40 (D 20, P 20)

Negative

Negative

 

Not reported

Fluoxetine<4>

X065

96 (D 48, P 48)

Positive

Negative

Published positive outcomes were not specified in the protocol.<5>

4

1

Fluoxetine<6>

HCJE

219 (D 109, P 110)

Positive

Negative

Negative after adjustment for baseline imbalance.<7>

5

9

Fluoxetine<8>

 

221* (D 109, P 112)

Negative

Negative

 

Not reported #

Paroxetine<9>

329

180 ** (D 93, P 87)

Positive

Negative

Published positive outcomes were not specified in the protocol.<10>

9

6

Paroxetine<11>

377

286 (D 187, P 99)

Negative

Negative

 

20

7

Paroxetine<12>

701

206 (D 104, P 102)

Negative

Negative

9

2

Citalopram<13>

CIT-MD-18

174 (D 89, P 85)

Positive

Possibly Positive

Protocol not publicly available

5

5

Citalopram<14>

94404

244 (D 124, P 120)

Negative

Negative

 

13/121

9/112

Escitalopram<15>

 

264 (D 131, P 133

Negative

Negative

2

2

Venlafaxine<16>

 

40 (D 20, P 20)

Negative

Negative

Not reported

Venlafaxine<17>

382

165 (D 80, P 85)

Negative

Negative

 

18

5

Venlafaxine<17>

394

196 (D 102, P 94)

Negative

Negative

 

Sertraline<18>

1001

188 (D 97, P 91)

Positive when combined but negative when analysed separately.

Negative

 

17

5

 

Sertraline<18>

1017

188 (D 92, P 96)

 

Negative

 

 

Unpublished trials

Nefazodone***

 

195 (D 99, P 96)

Negative

Negative

 

Nefazodone

CN104141

206 (D 106, P 100)

Negative ( Moreno were aware of only 2 nefazodone trials)

Negative

Nefazodone

CN104187

284 (D 190****,
P 94)

Negative

Mirtazapine

45 Study 1

126 (D 82, P 44)

Negative

Negative

Mirtazapine

45 Study 2

133 (D 88, P 44)

Negative

Negative

*Only includes patients randomized to fluoxetine or placebo.
** Only includes patients randomized to paroxetine or placebo.
***Presented at the 42nd Annual Meeting of NCDEU; 2002 Orlando, FL, USA. This may or may not be CN104141 or CN104187
****Nefazodone was given in high dose (n=95) and low dose (n=95)
# Even the paper on the Safety Results of this study<19> contains no figures on withdrawals due to adverse events.

Withdrawal due to Adverse Events

 

N (safety analysis)

Withdrawal due to AE

Drug

 

Drug

Placebo

Drug

Placebo

Fluoxetine<4>

96

48

48

4

1

Fluoxetine<6>

219

109

110

5

9

Paroxetine<9>

180

93

87

9

6

Paroxetine<11>

286

187

99

20

7

Paroxetine<12>

206

104

102

9

2

Citalopram<13>

174

89

85

5

5

Citalopram<14>

233

121

112

13

9

Escitalopram<15>

264

131

133

2

2

Venlafaxine<17>

165

80

85

18

5

Venlafaxine<17>

196

102

94

 

 

Sertraline<18>

188

97

91

17

5

Sertraline<18>

188

92

96

 

 

 

2395

1253

1142

102

51

 

 

 

 

8.14%

4.47%

 

View/Hide References

 

HS Int News index

Page views since 15 March 2010: 2933

 

Comments

Our members can see and make comments on this page.

 

  Healthy Skepticism on RSS   Healthy Skepticism on Facebook   Healthy Skepticism on Twitter

Please
Click to Register

(read more)

then
Click to Log in
for free access to more features of this website.

Forgot your username or password?

You are invited to
apply for membership
of Healthy Skepticism,
if you support our aims.

Pay a subscription

Support our work with a donation

Buy Healthy Skepticism T Shirts


If there is something you don't like, please tell us. If you like our work, please tell others. The contents of this page are the author's views and do not necessarily reflect the position of Healthy Skepticism or other members of Healthy Skepticism.

  • E-mail
  • LinkedIn
  • Del.icio.us
  • Digg
  • Facebook
  • FriendFeed
  • Google Bookmarks
  • MySpace
  • Reddit
  • Slashdot
  • StumbleUpon
  • Tumblr
  • Twitter
  • Yahoo! Bookmarks








Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909