NCT01119014

Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis

Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis- An Investigator-initiated, Phase IV, Randomised Double-blind Multi-centre Trial of the Benefits and Harms of Aripiprazole Versus Quetiapine in Children and Adolescents With Psychosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Anne Katrine Pagsberg · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

A sex and age matched healthy control group will be included to form a reference group for cognitive and somatic measures. The healthy controls will not receive any trial medication.

Conditions

• Psychosis

Interventions

Type	Name	Description
DRUG	Aripiprazole	pill, 2,5-20 mg/day, maximum 16 weeks
DRUG	Quetiapine	pill, 50-600mg/day, maximum 16 weeks

Timeline

• Start date: 2010-05-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2010-05-07
• Last updated: 2025-04-03

Locations

9 sites across 1 country: Denmark