March 2016. Volume 12. Number 1

Paroxetine and imipramine for major depression in adolescents: efficacy and harms?

 
 
 
 
 
 
 
 
 
 
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AVC | Critically appraised articles

Le Noury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320. 
Reviewers: Jullien S1, Cuestas Montañés E2.
1Departamento de Ciencias Clínicas, Liverpool School of Tropical Medicine. Liverpool. Reino Unido.
2Servicio de Pediatría y Neonatología. Hospital Privado. Centro Formador. Facultad de Ciencias Médicas. Universidad Nacional de Córdoba. Córdoba. Argentina.
Correspondence: Sophie Jullien. Email: sophjullien@gmail.com
Reception date: 14/12/2015
Acceptance date: 05/01/2016
Publication date: 13/01/2016

Abstract

Authors’ conclusions: neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs. Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety should not be read as authoritative.

Reviewers’ commentary: the initiative to restore clinical trials by means of primary data reanalysis according to initial protocol has shown false conclusions by deliberate concealment, modification of data and outcomes. The moral, regulatory and medical implications of this problem should reinforce the relevance and utility of secondary research to recognize and amend primary research fraud or misreport.

How to cite this article

Jullien S, Cuestas Montañés E. Paroxetina e imipramina para la depresión mayor en adolescentes: ¿ineficaces y peligrosas? Evid Pediatr. 2016;12:7.

AVC | Critically appraised articles

Le Noury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320. 
Reviewers: Jullien S1, Cuestas Montañés E2.
1Departamento de Ciencias Clínicas, Liverpool School of Tropical Medicine. Liverpool. Reino Unido.
2Servicio de Pediatría y Neonatología. Hospital Privado. Centro Formador. Facultad de Ciencias Médicas. Universidad Nacional de Córdoba. Córdoba. Argentina.
Correspondence: Sophie Jullien. Email: sophjullien@gmail.com
Reception date: 14/12/2015
Acceptance date: 05/01/2016
Publication date: 13/01/2016

How to cite this article

Jullien S, Cuestas Montañés E. Paroxetina e imipramina para la depresión mayor en adolescentes: ¿ineficaces y peligrosas? Evid Pediatr. 2016;12:7.

References

  1. Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2001;40:762-72.
  2. Hetrick SE, McKenzie JE, Cox GR, Simmons MB, Merry SN. Newer generation antidepressants for depressive disorders in children and adolescents. Cochrane Database Syst Rev. 2012;11:CD004851.
  3. Li W, Li W, Wan Y, Ren J, Li T, Li C. Appraisal of the methodological quality and summary of the findings of systematic reviews on the relationship between SSRIs and suicidality. Shanghai Arch Psychiatry. 2014;26:248-58.
  4. Cuestas ME, Cuestas E. Entropía aproximada del efecto placebo en ensayos clínicos con antidepresivos de nueva generación. Rev Fac Cien Med Univ Nac Cordoba. 2010;67:141-9.

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