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

BMC Psychiatry

Birgitte Fagerlund⁷  Anders Fink-Jensen¹  Christoph U Correll²  Jens Richardt M Jepsen⁷  Jørn Wetterslev^1,10  Maria Skoog^1,10  Christian Gluud^1,10  Klaus Juul³  Kristian Winge⁹  Thomas M Werge^1,11  Jakob Paludan^1,12  Per Hove Thomsen^1,12  Ditte Lammers Vernal⁴  Marlene B Lauritsen⁴  Sarah Madsen⁸  Louise Nyvang⁸  Jesper Pedersen⁸  Anne Dorte Stenstrøm⁵  Niels Bilenberg⁵  Maj-Britt Glenn Lauritsen⁶  Eva Ann-Sofie Saldeen⁶  Simone Rasmussen⁶  Peter Jantzen⁶  Marie Stentebjerg-Olesen⁶  Ditte Rudå⁶  Karsten Gjessing Jensen⁶  Dea Gowers Klauber⁶  Pia Jeppesen⁶  Anne Katrine Pagsberg⁶ 

[1] Laboratory of Neuropsychiatry, Department of Neuroscience and Pharmacology, University of Copenhagen and Psychiatric Centre Copenhagen, University Hospital Copenhagen, Edel Sauntes Allé 10, DK-2100 København Ø, Denmark;Hofstra North Shore Long Island Jewish School of Medicine and The Zucker Hillside Hospital, New York, 75-59 263rd Street, Glen Oaks, 11004 New York, USA;Department of Pediatrics, Rigshospitalet University Hospital, Blegdamsvej 9, DK- 2100 Copenhagen Ø, Denmark;Mental Health Centre for Child and Adolescent Psychiatry North Denmark Region, Research Unit, University of Aalborg, Mølleparkvej 10, Aalborg DK-9000, Denmark;Child and Adolescent Psychiatry Research Unit, Region of Southern Denmark, University of Southern Denmark, Sdr. Boulevard 29, Odense C DK-5000, Denmark;Child and Adolescent Mental Health Center, Mental Health Services - Capital Region of Denmark & Faculty of Health Science University of Copenhagen, Nordre Ringvej 69, Glostrup DK- 2600, Denmark;Centre for Neuropsychiatric Schizophrenia Research and Lundbeck Foundation Centre for Clinical Intervention and Neuropsychiatric Schizophrenia Research, Psychiatric Centre Glostrup, Ndr. Ringvej 29-67, DK- 2600 Glostrup, Denmark;Mental Health Centre for Child and Adolescent Psychiatry Region Zealand, Research Unit, University of Copenhagen, Smedegade 16, Roskilde DK-4000, Denmark;Department of Neurology, Bispebjerg Movement Disorders Biobank, Bispebjerg University Hospital, Bispebjerg Bakke 23, DK-2400 Copenhagen, NV, Denmark;Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK 2100 Copenhagen, Denmark;Psychiatric Centre Sct. Hans, Research Institute for Biological Psychiatry, University of Copenhagen, Boserupvej 2, Roskilde DK- 4000, Denmark;Mental Health Centre for Child and Adolescent Psychiatry Central Denmark Region, Research Unit, University of Aarhus, Harald Selmers Vej 66, Risskov DK- 8240, Denmark

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

Others  :  1123466
DOI  :  10.1186/1471-244X-14-199

 received in 2014-05-27, accepted in 2014-07-04,  发布年份 2014

【 摘 要 】

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-naïve 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.

Trial registration

ClinicalTrials.gov: NCT01119014

【 授权许可】

   
2014 Pagsberg et al.; licensee BioMed Central Ltd.

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