Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial
1 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
2 Child and Adolescent Psychiatry Research Unit, Region of Southern Denmark, University of Southern Denmark, Sdr. Boulevard 29, Odense C DK-5000, Denmark
3 Mental Health Centre for Child and Adolescent Psychiatry Region Zealand, Research Unit, University of Copenhagen, Smedegade 16, Roskilde DK-4000, Denmark
4 Mental Health Centre for Child and Adolescent Psychiatry North Denmark Region, Research Unit, University of Aalborg, Mølleparkvej 10, Aalborg DK-9000, Denmark
5 Mental Health Centre for Child and Adolescent Psychiatry Central Denmark Region, Research Unit, University of Aarhus, Harald Selmers Vej 66, Risskov DK- 8240, Denmark
6 Psychiatric Centre Sct. Hans, Research Institute for Biological Psychiatry, University of Copenhagen, Boserupvej 2, Roskilde DK- 4000, Denmark
7 Department of Neurology, Bispebjerg Movement Disorders Biobank, Bispebjerg University Hospital, Bispebjerg Bakke 23, DK-2400 Copenhagen, NV, Denmark
8 Department of Pediatrics, Rigshospitalet University Hospital, Blegdamsvej 9, DK- 2100 Copenhagen Ø, Denmark
9 Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK 2100 Copenhagen, Denmark
10 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
11 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
12 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
BMC Psychiatry 2014, 14:199 doi:10.1186/1471-244X-14-199Published: 11 July 2014
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.
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.
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.