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Unpublished trials |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****, |
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 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% |
2. Moreno C, Arango C, Parellada M, Shaffer D, Bird H. Antidepressants in child and adolescent depression: where are the bugs? Acta Psychiatr Scand. 2007 Mar;115(3):184-95.
3. Simeon JG, Dinicola VF, Ferguson HB, Copping W. Adolescent depression: a placebo-controlled fluoxetine treatment study and follow-up. Prog Neuropsychopharmacol Biol Psychiatry 1990;14:791–795.
4. Emslie GJ, Rush AJ, Weinberg WA et al. A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression. Arch Gen Psychiatry 1997;54:1031–1037.
5. Jureidini JN, Doecke CJ, Mansfield PR, Haby MM, Menkes DB, Tonkin AL. Efficacy and safety of antidepressants for children and adolescents. BMJ 2004;328:879-83
6. Emslie GJ, Heiligenstein JH, Wagner KD et al. Fluoxetine for acute treatment of depression in children and adolescents: a placebo-controlled, randomized clinical trial. J Am Acad Child Adolesc Psychiatry 2002;41:1205–1215.
7. Garland EJ. Facing the Evidence: Antidepressant Treatment in Children and Adolescents. CMAJ: 2004; 170: 489 – 491
8. March J, Silva S, Petrycki S et al. Fluoxetine, cognitive behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA 2004;292:807–820.
9. Keller MB, Ryan ND, Strober M et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry 2001;40:762–772.
10. GlaxoSmithKline. Paroxetine and pediatric and adolescent patients. www.gsk.com/media/paroxetine.htm (accessed 23 February 2007)
11. Berard R, Fong R, Carpenter DJ, Thomason C, Wilkinson C. An international, multicenter, placebo-controlled trial ofparoxetine in adolescents with major depressive disorder. J Child Adolesc Psychopharmacol 2006;16:59–75.
12. Emslie GJ, Wagner KD, Kutcher S et al. Paroxetine treatment in children and adolescents with major depressive disorder: a randomized, multicenter, doubleblind, placebo-controlled trial. J Am Acad Child Adolesc Psychiatry 2006;45:709–719.
13. Wagner KD, Robb AS, Findling RL et al. A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents. Am J Psychiatry 2004;161:1079–1083.
14. Von Knorring AL, Olsson GI, Thomsen PH, Lemming OM, Hulten A. A randomized, double-blind, placebo-controlled study of citalopram in adolescents with major depressive disorder. J Clin Psychopharmacol 2006;26: 311–315.
15. Wagner KD, Jonas J, Findling RL, Ventura D, Saikali K. A double-blind, randomized, placebo-controlled trial of escitalopram in the treatment of pediatric depression. J Am Acad Child Adolesc Psychiatry 2006;45:280–288.
16. Mandoki MW, Tapia MR, Tapia MA, Sumner GS, Parker JL. Venlafaxine in the treatment of children and adolescents with major depression. Psychopharmacol Bull 1997;33:149–154.
17. Emslie GJ, Findling RL, Yeung PP, Kunz NR, Li Y. Venlafaxine ER for the treatment of pediatric subjects with depression: results of two placebo-controlled trials. J Am Acad Child Adolesc Psychiatry. 2007 Apr;46(4):479-88.
18. Wagner KD, Ambrosini P, Rynn M et al. Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder: two randomized controlled trials. JAMA 2003;290:1033–1041.
19. Emslie G, Kratochvil C, Vitiello B, Silva S, Mayes T, McNulty S, Weller E, Waslick B, Casat C, Walkup J, Pathak S, Rohde P, Posner K, March J; Columbia Suicidality Classification Group; TADS Team. Treatment for Adolescents with Depression Study (TADS): safety results. J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1440-55.
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