Open Access Study protocol

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

Anne Katrine Pagsberg1*, Pia Jeppesen1, Dea Gowers Klauber1, Karsten Gjessing Jensen1, Ditte Rudå1, Marie Stentebjerg-Olesen1, Peter Jantzen1, Simone Rasmussen1, Eva Ann-Sofie Saldeen1, Maj-Britt Glenn Lauritsen1, Niels Bilenberg2, Anne Dorte Stenstrøm2, Jesper Pedersen3, Louise Nyvang3, Sarah Madsen3, Marlene B Lauritsen4, Ditte Lammers Vernal4, Per Hove Thomsen5, Jakob Paludan5, Thomas M Werge6, Kristian Winge7, Klaus Juul8, Christian Gluud9, Maria Skoog9, Jørn Wetterslev9, Jens Richardt M Jepsen10, Christoph U Correll11, Anders Fink-Jensen12 and Birgitte Fagerlund10

Author Affiliations

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

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BMC Psychiatry 2014, 14:199  doi:10.1186/1471-244X-14-199

Published: 11 July 2014

Abstract

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

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