Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis

Summary

The benefits and harms of antipsychotics are relatively well studied in adults. However, there is a lack of scientifically valid studies regarding the benefits and harms of antipsychotics in children and adolescents with psychosis.

The main objective of the TEA trial is to compare the efficacy and adverse reactions of two antipsychotics (quetiapine versus aripiprazole) in children and adolescents between 12-17 years of age with psychotic symptoms on psychopathology, cognitive deficits, and daily functioning. Furthermore, the trial will focus on adverse reaction profiles of the two antipsychotics as well as early predictors of later sustained clinical effects of these antipsychotics.

Conditions

• Psychosis

Interventions

DRUG

Aripiprazole

pill, 2,5-20 mg/day, maximum 16 weeks

DRUG

Quetiapine

pill, 50-600mg/day, maximum 16 weeks

Sponsors & Collaborators

• The Psychiatric Centre for Children and Adolescents in Bispebjerg, Denmark

  collaborator UNKNOWN

• Psychiatric Centre Copenhagen, Denmark

  collaborator UNKNOWN

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Albert Einstein College of Medicine

  collaborator OTHER

• Research Institute for Biological Psychiatry, Sct. Hans Hospital, Denmark

  collaborator UNKNOWN

• Capital Region Pharmacy, Denmark

  collaborator UNKNOWN

• The Research Council for Health and Disease, Denmark

  collaborator OTHER

• Allocated inheritance from Elizabeth Stevn and Niels Rindom, Denmark

  collaborator UNKNOWN

• AP Moeller Foundation

  collaborator OTHER

• Tryg Fonden, Denmark

  collaborator UNKNOWN

• Anne Katrine Pagsberg

  lead OTHER

Principal Investigators

• Anne Katrine Pagsberg, MD, Ph.D. · Bispebjerg Centre for Child and Adolescent Psychiatry. University of Copenhagen.

• Pia Jeppesen, MD, Ph.D. · Glostrup Centre for Child and Adolescent Psychiatry. University of Copenhagen.

• Maj-Britt Lauritsen, MD · Hillerød Centre for Child and Adolescent Psychiatry.

• Per Hove-Thomsen, Professor, MD, D.M.Sci. · Psychiatric Hospital for Children and Adolescents, Aarhus University Hospital.

• Marlene Briciet Lauritsen, MD. · Child- and Adolescent Psychiatric Department, Aalborg.

• Niels Bilenberg, Professor, MD. · Child and Adolescent Psychiatric Department, University of Southern Denmark, Odense

• Thomas Werge, Professor, Ph.D. · Research Institute for Biological Psychiatry, Sct. Hans Hospital, Roskilde.

• Anders Fink-Jensen, MD, professor, DMSci. · Psychiatric Centre Copenhagen. University of Copenhagen.

• Jesper Pedersen, MD. · Psychiatric Hospital for Children and Adolescent; Region Zeeland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2015-07-31

Completion

2015-07-31

Countries

• Denmark

Study Locations