title: Quetiapine versus aripiprazole in children and adolescents with psychosis--protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01119014.
authors.affiliation: 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. Anne.Katrine.Pagsberg@Regionh.dk.
authors.forename: Anne Katrine
authors.initials: AK
authors.lastname: Pagsberg
authors.forename: Pia
authors.initials: P
authors.lastname: Jeppesen
authors.forename: Dea Gowers
authors.initials: DG
authors.lastname: Klauber
authors.forename: Karsten Gjessing
authors.initials: KG
authors.lastname: Jensen
authors.forename: Ditte
authors.initials: D
authors.lastname: Rudå
authors.forename: Marie
authors.initials: M
authors.lastname: Stentebjerg-Olesen
authors.forename: Peter
authors.initials: P
authors.lastname: Jantzen
authors.forename: Simone
authors.initials: S
authors.lastname: Rasmussen
authors.forename: Eva Ann-Sofie
authors.initials: EA
authors.lastname: Saldeen
authors.forename: Maj-Britt Glenn
authors.initials: MB
authors.lastname: Lauritsen
authors.forename: Niels
authors.initials: N
authors.lastname: Bilenberg
authors.forename: Anne Dorte
authors.initials: AD
authors.lastname: Stenstrøm
authors.forename: Jesper
authors.initials: J
authors.lastname: Pedersen
authors.forename: Louise
authors.initials: L
authors.lastname: Nyvang
authors.forename: Sarah
authors.initials: S
authors.lastname: Madsen
authors.forename: Marlene B
authors.initials: MB
authors.lastname: Lauritsen
authors.forename: Ditte Lammers
authors.initials: DL
authors.lastname: Vernal
authors.forename: Per Hove
authors.initials: PH
authors.lastname: Thomsen
authors.forename: Jakob
authors.initials: J
authors.lastname: Paludan
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Werge
authors.forename: Kristian
authors.initials: K
authors.lastname: Winge
authors.forename: Klaus
authors.initials: K
authors.lastname: Juul
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.forename: Maria
authors.initials: M
authors.lastname: Skoog
authors.forename: Jørn
authors.initials: J
authors.lastname: Wetterslev
authors.forename: Jens Richardt M
authors.initials: JR
authors.lastname: Jepsen
authors.forename: Christoph U
authors.initials: CU
authors.lastname: Correll
authors.forename: Anders
authors.initials: A
authors.lastname: Fink-Jensen
authors.forename: Birgitte
authors.initials: B
authors.lastname: Fagerlund
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D002648:Child; D003987:Dibenzothiazepines / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D018579:Patient Selection; D010879:Piperazines / Q000627:therapeutic use*; D011618:Psychotic Disorders / Q000188:drug therapy*; D011788:Quality of Life; D000069348:Quetiapine Fumarate; D015363:Quinolones / Q000627:therapeutic use*; D018401:Sample Size; D012559:Schizophrenia / Q000188:drug therapy*
chemical_list: D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D010879:Piperazines; D015363:Quinolones; D000069348:Quetiapine Fumarate; D000068180:Aripiprazole