4.5 Article

Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial

Journal

BMC PSYCHIATRY
Volume 14, Issue -, Pages -

Publisher

BIOMED CENTRAL LTD
DOI: 10.1186/1471-244X-14-199

Keywords

Antipsychotics; Quetiapine; Aripiprazole; Psychosis; Schizophrenia; Children; Adolescents; Randomised trial; Benefits; Harms

Categories

Funding

  1. National Research Council for Health and Disease [DKK 17.902.604]
  2. Foundation for health promotion
  3. Rosalie Petersens Foundation
  4. Stevn and Rindom Foundation
  5. Capital Region Psychiatric Research Foundation
  6. A.P. Moller Foundation
  7. Tryg Fonden
  8. Capital Region Research Foundation
  9. Region of Southern Denmark Research Foundation
  10. Psychiatry Foundation
  11. Knud og Dagny Andresens Foundation
  12. Psychiatric Research Foundation
  13. Dr. Sofus Carl Emil Friis and Hustru Olga Friis Scholarship
  14. Psychiatric Research Foundation Region Zealand
  15. Tomrerhandler Johannes Fogs Foundation
  16. Brdr Hartmanns Foundation
  17. Aase and Ejnar Danielsens Foundation
  18. Jacob Madsen and wife Olga Madsens Foundation
  19. C.C. Klestrup and wife Scholarship
  20. Tomrermester Jorgen Holm and wife Elisas Scholarship
  21. Lundbeck Foundation [R155-2013-16337, R155-2014-1724] Funding Source: researchfish

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Background: The evidence for choices between antipsychotics for children and adolescents with schizophrenia and other psychotic disorders is limited. The main objective of the Tolerability and Efficacy of Antipsychotics (TEA) trial is to compare the benefits and harms of quetiapine versus aripiprazole in children and adolescents with psychosis in order to inform rational, effective and safe treatment selections. Methods/Design: The TEA trial is a Danish investigator-initiated, independently funded, multi-centre, randomised, blinded clinical trial. Based on sample size estimation, 112 patients aged 12-17 years with psychosis, antipsychotic-naive or treated for a limited period are, 1:1 randomised to a 12-week, double-blind intervention with quetiapine versus aripiprazole. Effects on psychopathology, cognition, health-related quality of life, and adverse events are assessed 2, 4, and 12 weeks after randomisation. The primary outcome is change in the positive symptom score of the Positive and Negative Syndrome Scale. The recruitment period is 2010-2014. Discussion: Antipsychotics are currently the only available pharmacologic treatments for psychotic disorders. However, information about head-to-head differences in efficacy and tolerability of antipsychotics are scarce in children and adolescents. The TEA trial aims at expanding the evidence base for the use of antipsychotics in early onset psychosis in order to inform more rational treatment decisions in this vulnerable population. Here, we account for the trial design, address methodological challenges, and discuss the estimation of sample size.

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