CompletedPhase 4

Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis

Denmark300 participantsStarted 2010-05

Plain-language 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.

Who can participate

Age range12 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Patients - Inclusion Criteria: * Diagnosis: Children and adolescents with a non-organic and non-drug-induced psychosis, meeting the criteria for ICD-10 diagnoses: F20, F22-F29 and F30.2, F31.2 F31.5, F32.3 and F33.3. This is verified with a semi-structured psychopathological interview using K-SADS-PL (Kaufmann 1997) four weeks after inclusion into the trial. * Psychopathology: Children and adolescents with psychotic symptoms, scoring ≥ 4 on at least one of the following PANSS items: P1 (delusions), P2 (conceptual disorganisation), P3 (hallucinations), P5 (grandiosity), P6 (suspiciousness/persecution) or G9 (unusual thought content); and a total PANSS score \> 60. The treating physician has decided to prescribe an antipsychotic compound. * Age: 12-17 years (both inclusive). * Sex: Both sexes are included. * Previous treatment: Patients must be antipsychotic-naïve. The maximum accepted previous treatment with antipsychotic compounds is two weeks cumulatively, and during the two weeks prior to inclusion no continuous treatment and a maximum of four dosages in total can have been received. * Somatic illness: No somatic contraindication to planned medication, documented by standard somatic examination * Written informed consent. Patients - Exclusion Criteria: * Compulsory treatment: Patients that are compulsorily hospitalised against their will are excluded. If their status changes to voluntary hospitalisation, patients can be included. If the patient is already included in the…

What they're measuring

Psychopathology: improvement on PANSS positive scale (PANSS 'Positive and Negative Syndrome Scale')

Timeframe: 12 weeks

Trial details

NCT IDNCT01119014

SponsorAnne Katrine Pagsberg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07