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

• Published in: BMC psychiatry Vol. 14; no. 1; p. 199
• Main Authors: Pagsberg, Anne Katrine, Jeppesen, Pia, Klauber, Dea Gowers, Jensen, Karsten Gjessing, Rudå, Ditte, Stentebjerg-Olesen, Marie, Jantzen, Peter, Rasmussen, Simone, Saldeen, Eva Ann-Sofie, Lauritsen, Maj-Britt Glenn, Bilenberg, Niels, Stenstrøm, Anne Dorte, Pedersen, Jesper, Nyvang, Louise, Madsen, Sarah, Lauritsen, Marlene B, Vernal, Ditte Lammers, Thomsen, Per Hove, Paludan, Jakob, Werge, Thomas M, Winge, Kristian, Juul, Klaus, Gluud, Christian, Skoog, Maria, Wetterslev, Jørn, Jepsen, Jens Richardt M, Correll, Christoph U, Fink-Jensen, Anders, Fagerlund, Birgitte
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 11-07-2014; BioMed Central
• Subjects: Adolescent; Antipsychotic Agents - therapeutic use; Antipsychotics; Aripiprazole; Child; Child psychopathology; Children & youth; Comparative analysis; Dibenzothiazepines - therapeutic use; Double-Blind Method; Drug therapy; Female; Hospitals; Humans; Male; Medicine, Botanic; Medicine, Herbal; Patient Selection; Piperazines - therapeutic use; Prognosis; Psychiatry; Psychosis; Psychotic Disorders - drug therapy; Psychotropic drugs; Quality of Life; Quetiapine Fumarate; Quinolones - therapeutic use; Risk factors; Sample Size; Schizophrenia; Schizophrenia - drug therapy; Study Protocol; Teenagers
• ISSN: 1471-244X; 1471-244X
• DOI: 10.1186/1471-244X-14-199

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.
ClinicalTrials.gov: NCT01119014.