Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis

NCT01119014 | Completed Phase 4 DMC

• 2 other identifiers: TEAprotocolversion5-11 03 20102009-016715-38
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

Aripiprazole; Quetiapine; Psychosis; Child; Adolescent

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (8)

• Psychopathology

  12 weeks

• Cognition

  12 weeks

• Adverse reactions

  12 weeks

• Suicidal ideation

  12 weeks

• Genetic and antipsychotic laboratory tests

  12 weeks

Study Arms (2)

Aripirazole

EXPERIMENTAL

Drug: Aripiprazole

Quetiapine prolong

EXPERIMENTAL

Drug: Quetiapine

Interventions

Aripiprazole DRUG

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

Aripirazole

Quetiapine DRUG

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

Quetiapine prolong

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Somatic illness: No somatic contraindication to planned medication, documented by standard somatic examination
• Written informed consent.

You may not qualify if:

• 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.
• 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.
• 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.
• Somatic illnesses: People with severe chronic somatic illness or a history of severe head-trauma are not included.
• Lack of informed consent.

Sponsors & Collaborators

• Anne Katrine Pagsberg: lead
• The Psychiatric Centre for Children and Adolescents in Bispebjerg, Denmark: collaborator
• Psychiatric Centre Copenhagen, Denmark: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Albert Einstein College of Medicine: collaborator
• Research Institute for Biological Psychiatry, Sct. Hans Hospital, Denmark: collaborator
• Capital Region Pharmacy, Denmark: collaborator
• The Research Council for Health and Disease, Denmark: collaborator
• Allocated inheritance from Elizabeth Stevn and Niels Rindom, Denmark: collaborator
• AP Moeller Foundation: collaborator
• Tryg Fonden, Denmark: collaborator

Study Sites (9)

Aalborg Psychiatric Hospital

Aalborg, 9000, Denmark

Location

Psychiatric Centre Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Hillerød Hospital

Hillerød, 3400, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Psychiatric Hospital for Children and Adolescents, Aarhus

Risskov, 8240, Denmark

Location

Child and Adolescent Psychiatric Department, Region Zealand

Roskilde, 4000, Denmark

Location

Psychiatric Centre Sct. Hans

Roskilde, 4000, Denmark

Location

Related Publications (7)

• 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.

  PMID: 38869653 DERIVED

• 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.

  PMID: 35026408 DERIVED

• 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.

  PMID: 30858012 DERIVED

• 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.

  PMID: 29185022 DERIVED

• 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.

  PMID: 28599949 DERIVED

• 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.

  PMID: 28102978 DERIVED

• 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.

  PMID: 25015535 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Aripiprazole; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring

Study Officials

• Anne Katrine Pagsberg, MD, Ph.D.

  Bispebjerg Centre for Child and Adolescent Psychiatry. University of Copenhagen.

  PRINCIPAL INVESTIGATOR

• Pia Jeppesen, MD, Ph.D.

  Glostrup Centre for Child and Adolescent Psychiatry. University of Copenhagen.

  PRINCIPAL INVESTIGATOR

• Maj-Britt Lauritsen, MD

  Hillerød Centre for Child and Adolescent Psychiatry.

  PRINCIPAL INVESTIGATOR

• Per Hove-Thomsen, Professor, MD, D.M.Sci.

  Psychiatric Hospital for Children and Adolescents, Aarhus University Hospital.

  PRINCIPAL INVESTIGATOR

• Marlene Briciet Lauritsen, MD.

  Child- and Adolescent Psychiatric Department, Aalborg.

  PRINCIPAL INVESTIGATOR

• Niels Bilenberg, Professor, MD.

  Child and Adolescent Psychiatric Department, University of Southern Denmark, Odense

  PRINCIPAL INVESTIGATOR

• Thomas Werge, Professor, Ph.D.

  Research Institute for Biological Psychiatry, Sct. Hans Hospital, Roskilde.

  PRINCIPAL INVESTIGATOR

• Anders Fink-Jensen, MD, professor, DMSci.

  Psychiatric Centre Copenhagen. University of Copenhagen.

  PRINCIPAL INVESTIGATOR

• Jesper Pedersen, MD.

  Psychiatric Hospital for Children and Adolescent; Region Zeeland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD., PhD

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 7, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

DK (9)