Psychosis Clinical Trial
Official title:
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
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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