Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis
NCT ID: NCT01119014
Last Updated: 2025-04-03
Study Results
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Basic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2010-05-31
2015-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Aripirazole
Aripiprazole
pill, 2,5-20 mg/day, maximum 16 weeks
Quetiapine prolong
Quetiapine
pill, 50-600mg/day, maximum 16 weeks
Interventions
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Aripiprazole
pill, 2,5-20 mg/day, maximum 16 weeks
Quetiapine
pill, 50-600mg/day, maximum 16 weeks
Eligibility Criteria
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Inclusion Criteria
* 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.
* Matching: Healthy controls (n=100) are included, in the way that they are matched to the first 100 patients included in the study (i.e., corresponding to the number of patients required in each treatment group). They will be matched according to:
* age;
* sex; and
* socioeconomic status (based on a combination of parental education and income, according to criteria from the National Institute of Public Health (earlier Danish Institute of Clinical Epidemiology, DIKE)).
* Informed consent.
Exclusion Criteria
* Diagnoses: Patients with drug-induced or organic psychosis, severe chronic somatic illness, or a history of severe head-trauma are not included. Patients that do not have psychotic symptoms but are prescribed antipsychotic treatment on the indication of, e.g., severe behavioural problems or tics are not included.
* Pregnancy: Pregnant or lactating patients are not included (a pregnancy test is undertaken at inclusion). Female participants, that are sexually active, must use safe contraception throughout the trial period (see section 6.4)
* Substance abuse: People with severe alcohol or drug abuse are not included. Possible abuse is monitored both by interviewing participants and by taking a urine sample at inclusion and at 4, 12 and 52 weeks follow-up (if there is suspicion of substance abuse), testing for the presence of cocaine, amphetamine, cannabis, opiates, metamfetamine (inclusive for extacy), and benzodiazepines. When severe abuse is suspected during the trial, an ad hoc urine sample is taken. Brief periods of large alcohol/cannabis intake are not a cause of exclusion from the trial; however, cognitive and other examinations are not carried out while patients are under the influence of drugs or alcohol.
* Aggravation: Patients may be excluded if there is a significant worsening of clinical state during the course of the trial (i.e., increases of 30% or more from baseline on the PANSS total score).
* Allergy and intolerance: Patients with allergy towards the investigational drugs, or is lactose intolerant are not included.
* Lack of informed consent.
* Psychopathology: People with a previous psychotic disorder (ICD 10, F20-F29 and F30.2, F31.2, F31.5, F32.3 and F33.3) or current psychiatric disorder (multiaxial axis 1) are not included. This is verified by diagnostic screening using K-SADS-PL at eligibility assessment before inclusion into the study of healthy controls. The presence of psychotic psychiatric diagnoses in first-degree relatives is also a cause for exclusion.
* Somatic illnesses: People with severe chronic somatic illness or a history of severe head-trauma are not included.
* Intelligence: People with known mild mental retardation (i.e., IQ between 50-70) prior to inclusion are excluded; however, if mild mental retardation is found during the study, participants are not excluded, since they must be considered a marginal part of the normal distribution. People with moderate to severe mental retardation (i.e., IQ \< 50) are excluded.
* Substance abuse: People with severe alcohol- or drug abuse are excluded. Possible abuse is monitored both by interviewing participants and by taking a urine sample at inclusion and at 4, 12 and 52 weeks follow-up (if there is suspicion of substance abuse), testing for the presence of cocaine, amphetamine, cannabis, opiates, metamfetamine (inclusive for extacy) and benzodiazepines. Brief periods of large alcohol/cannabis intake are not a cause of exclusion from the study; however, cognitive and other examinations are not carried out while participants are under the influence.
* Lack of informed consent.
12 Years
17 Years
ALL
Yes
Sponsors
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The Psychiatric Centre for Children and Adolescents in Bispebjerg, Denmark
UNKNOWN
Psychiatric Centre Copenhagen, Denmark
UNKNOWN
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Albert Einstein College of Medicine
OTHER
Research Institute for Biological Psychiatry, Sct. Hans Hospital, Denmark
UNKNOWN
Capital Region Pharmacy, Denmark
UNKNOWN
The Research Council for Health and Disease, Denmark
OTHER
Allocated inheritance from Elizabeth Stevn and Niels Rindom, Denmark
UNKNOWN
AP Moeller Foundation
OTHER
Tryg Fonden, Denmark
UNKNOWN
Anne Katrine Pagsberg
OTHER
Responsible Party
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Anne Katrine Pagsberg
MD., PhD
Principal Investigators
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Anne Katrine Pagsberg, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Centre for Child and Adolescent Psychiatry. University of Copenhagen.
Pia Jeppesen, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Glostrup Centre for Child and Adolescent Psychiatry. University of Copenhagen.
Maj-Britt Lauritsen, MD
Role: PRINCIPAL_INVESTIGATOR
Hillerød Centre for Child and Adolescent Psychiatry.
Per Hove-Thomsen, Professor, MD, D.M.Sci.
Role: PRINCIPAL_INVESTIGATOR
Psychiatric Hospital for Children and Adolescents, Aarhus University Hospital.
Marlene Briciet Lauritsen, MD.
Role: PRINCIPAL_INVESTIGATOR
Child- and Adolescent Psychiatric Department, Aalborg.
Niels Bilenberg, Professor, MD.
Role: PRINCIPAL_INVESTIGATOR
Child and Adolescent Psychiatric Department, University of Southern Denmark, Odense
Thomas Werge, Professor, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Research Institute for Biological Psychiatry, Sct. Hans Hospital, Roskilde.
Anders Fink-Jensen, MD, professor, DMSci.
Role: PRINCIPAL_INVESTIGATOR
Psychiatric Centre Copenhagen. University of Copenhagen.
Jesper Pedersen, MD.
Role: PRINCIPAL_INVESTIGATOR
Psychiatric Hospital for Children and Adolescent; Region Zeeland
Locations
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Aalborg Psychiatric Hospital
Aalborg, , Denmark
Psychiatric Centre Copenhagen, Rigshospitalet
Copenhagen, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Glostrup Hospital
Glostrup Municipality, , Denmark
Hillerød Hospital
Hillerød, , Denmark
Odense University Hospital
Odense, , Denmark
Psychiatric Hospital for Children and Adolescents, Aarhus
Risskov, , Denmark
Child and Adolescent Psychiatric Department, Region Zealand
Roskilde, , Denmark
Psychiatric Centre Sct. Hans
Roskilde, , Denmark
Countries
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References
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Klauber DG, Christensen SH, Fink-Jensen A, Pagsberg AK. I Didn't Want the Psychotic Thing to Get Out to Anyone at All: Adolescents with Early Onset Psychosis Managing Stigma. Cult Med Psychiatry. 2024 Sep;48(3):569-590. doi: 10.1007/s11013-024-09859-3. Epub 2024 Jun 13.
Pagsberg AK, Krogmann A, Jeppesen P, von Hardenberg L, Klauber DG, Jensen KG, Ruda D, Decara MS, Jepsen JRM, Fagerlund B, Fink-Jensen A, Correll CU, Galling B. Early Antipsychotic Nonresponse as a Predictor of Nonresponse and Nonremission in Adolescents With Psychosis Treated With Aripiprazole or Quetiapine: Results From the TEA Trial. J Am Acad Child Adolesc Psychiatry. 2022 Aug;61(8):997-1009. doi: 10.1016/j.jaac.2021.11.032. Epub 2022 Jan 10.
Jensen KG, Correll CU, Ruda D, Klauber DG, Decara MS, Fagerlund B, Jepsen JRM, Eriksson F, Fink-Jensen A, Pagsberg AK. Cardiometabolic Adverse Effects and Its Predictors in Children and Adolescents With First-Episode Psychosis During Treatment With Quetiapine-Extended Release Versus Aripiprazole: 12-Week Results From the Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis (TEA) Trial. J Am Acad Child Adolesc Psychiatry. 2019 Nov;58(11):1062-1078. doi: 10.1016/j.jaac.2019.01.015. Epub 2019 Mar 9.
Jensen KG, Gartner S, Correll CU, Ruda D, Klauber DG, Stentebjerg-Olesen M, Fagerlund B, Jepsen JR, Fink-Jensen A, Juul K, Pagsberg AK. Change and dispersion of QT interval during treatment with quetiapine extended release versus aripiprazole in children and adolescents with first-episode psychosis: results from the TEA trial. Psychopharmacology (Berl). 2018 Mar;235(3):681-693. doi: 10.1007/s00213-017-4784-5. Epub 2017 Nov 29.
Pagsberg AK, Jeppesen P, Klauber DG, Jensen KG, Ruda D, Stentebjerg-Olesen M, Jantzen P, Rasmussen S, Saldeen EA, Lauritsen MG, Bilenberg N, Stenstrom AD, Nyvang L, Madsen S, Werge TM, Lange T, Gluud C, Skoog M, Winkel P, Jepsen JRM, Fagerlund B, Correll CU, Fink-Jensen A. Quetiapine extended release versus aripiprazole in children and adolescents with first-episode psychosis: the multicentre, double-blind, randomised tolerability and efficacy of antipsychotics (TEA) trial. Lancet Psychiatry. 2017 Aug;4(8):605-618. doi: 10.1016/S2215-0366(17)30166-9. Epub 2017 Jun 7.
Jensen KG, Correll CU, Ruda D, Klauber DG, Stentebjerg-Olesen M, Fagerlund B, Jepsen JRM, Fink-Jensen A, Pagsberg AK. Pretreatment Cardiometabolic Status in Youth With Early-Onset Psychosis: Baseline Results From the TEA Trial. J Clin Psychiatry. 2017 Sep/Oct;78(8):e1035-e1046. doi: 10.4088/JCP.15m10479.
Pagsberg AK, Jeppesen P, Klauber DG, Jensen KG, Ruda D, Stentebjerg-Olesen M, Jantzen P, Rasmussen S, Saldeen EA, Lauritsen MB, Bilenberg N, Stenstrom AD, Pedersen J, Nyvang L, Madsen S, Lauritsen MB, Vernal DL, Thomsen PH, Paludan J, Werge TM, Winge K, Juul K, Gluud C, Skoog M, Wetterslev J, Jepsen JR, Correll CU, Fink-Jensen A, Fagerlund B. Quetiapine versus aripiprazole in children and adolescents with psychosis--protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial. BMC Psychiatry. 2014 Jul 11;14:199. doi: 10.1186/1471-244X-14-199.
Other Identifiers
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2009-016715-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TEAprotocolversion5-11 03 2010
Identifier Type: -
Identifier Source: org_study_id
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