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

BMC Psychiatry

Study Protocol

Birgitte Fagerlund¹  Jens Richardt M Jepsen¹  Marie Stentebjerg-Olesen²  Ditte Rudå²  Karsten Gjessing Jensen²  Eva Ann-Sofie Saldeen²  Maj-Britt Glenn Lauritsen²  Peter Jantzen²  Simone Rasmussen²  Pia Jeppesen²  Dea Gowers Klauber²  Anne Katrine Pagsberg²  Niels Bilenberg³  Anne Dorte Stenstrøm³  Christian Gluud⁴  Jørn Wetterslev⁴  Maria Skoog⁴  Kristian Winge⁵  Klaus Juul⁶  Christoph U Correll⁷  Anders Fink-Jensen⁸  Per Hove Thomsen⁹  Jakob Paludan⁹  Marlene B Lauritsen^1,10  Ditte Lammers Vernal^1,10  Sarah Madsen^1,11  Louise Nyvang^1,11  Jesper Pedersen^1,11  Thomas M Werge^1,12 

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

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

DOI  :  10.1186/1471-244X-14-199

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

来源: Springer

【 摘 要 】

BackgroundThe 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/DesignThe 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.DiscussionAntipsychotics 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 registrationClinicalTrials.gov: NCT01119014

【 授权许可】

CC BY   
© Pagsberg et al.; licensee BioMed Central Ltd. 2014