Forskning
Udskriv Udskriv
Switch language
Rigshospitalet - en del af Københavns Universitetshospital
Udgivet

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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. Early specialised palliative care: interventions, symptoms, problems

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia: the COVID STEROID randomised, placebo-controlled trial

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities

    Publikation: Bidrag til tidsskriftReviewForskningpeer review

  • Anne Katrine Pagsberg
  • Pia Jeppesen
  • Dea Gowers Klauber
  • Karsten Gjessing Jensen
  • Ditte Rudå
  • Marie Stentebjerg-Olesen
  • Peter Jantzen
  • Simone Rasmussen
  • Eva Ann-Sofie Saldeen
  • Maj-Britt Glenn Lauritsen
  • Niels Bilenberg
  • Anne Dorte Stenstrøm
  • Jesper Pedersen
  • Louise Nyvang
  • Sarah Madsen
  • Marlene B Lauritsen
  • Ditte Lammers Vernal
  • Per Hove Thomsen
  • Jakob Paludan
  • Thomas M Werge
  • Kristian Winge
  • Klaus Juul
  • Christian Gluud
  • Maria Skoog
  • Jørn Wetterslev
  • Jens Richardt Jepsen
  • Christoph U Correll
  • Anders Fink-Jensen
  • Birgitte Fagerlund
Vis graf over relationer

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: The TEA trial is 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 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.Trial registration: ClinicalTrials.gov: NCT01119014.

OriginalsprogEngelsk
TidsskriftB M C Psychiatry
Vol/bind14
Udgave nummer1
Sider (fra-til)199
ISSN1471-244X
DOI
StatusUdgivet - 11 jul. 2014

ID: 44440351