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Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis (TEA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Psychiatric Centre for Children and Adolescents in Bispebjerg, Denmark
Psychiatric Centre Copenhagen, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Albert Einstein College of Medicine of Yeshiva University
Research Institute for Biological Psychiatry, Sct. Hans Hospital, Denmark
Capital Region Pharmacy, Denmark
The Research Council for Health and Disease, Denmark
Allocated inheritance from Elizabeth Stevn and Niels Rindom, Denmark
AP Moeller Foundation
Tryg Fonden, Denmark
Information provided by (Responsible Party):
Anne Katrine Pagsberg, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01119014
First received: May 3, 2010
Last updated: October 2, 2014
Last verified: October 2014

May 3, 2010
October 2, 2014
May 2010
February 2015   (final data collection date for primary outcome measure)
Psychopathology: improvement on PANSS positive scale (PANSS 'Positive and Negative Syndrome Scale') [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01119014 on ClinicalTrials.gov Archive Site
  • Psychopathology [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Psychopathology (other PANSS scales, DIPI, SGI-S, CGI-I,and GAPD).
  • Cognition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Cognition and functioning (BACS Global Score, SCoRS-DK, Schizophrenia Cognition Rating Scale, BRIEF)
  • Adverse reactions [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Adverse reactions (UKU side effect scale, AIMS, SAS, BARS, and other adverse events)
  • Suicidal ideation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Suicidal ideation (K-SADS-PL, specific questions for depressive disorders (current)
  • Genetic and antipsychotic laboratory tests [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Genetic variants affecting metabolism of antipsychotics
  • Prognostic factors [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Prognostic factors (DUP, and PAS)
  • Quality of Life [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Quality of Life (measured with Kidscreen)
  • Stigmatization [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Qualitative interviews
  • Psychopathology [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Psychopathology (other PANSS scales, DIPI, SGI-S, CGI-I,and GAPD).
  • Cognition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Cognition and functioning (BACS Global Score, SCoRS-DK, Schizophrenia Cognition Rating Scale, BRIEF)
  • Adverse reactions [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Adverse reactions (UKU side effect scale, AIMS, SAS, BARS, and other adverse events)
  • Suicidal ideation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Suicidal ideation (K-SADS-PL, specific questions for depressive disorders (current)
  • Genetic and antipsychotic laboratory tests [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Genetic variants affecting metabolism of antipsychotics
  • Prognostic factors [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Prognostic factors (DUP, and PAS)
Not Provided
Not Provided
 
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psychosis
  • Drug: Aripiprazole
    pill, 2,5-20 mg/day, maximum 16 weeks
  • Drug: Quetiapine
    pill, 50-600mg/day, maximum 16 weeks
  • Experimental: Aripirazole
    Intervention: Drug: Aripiprazole
  • Experimental: Quetiapine prolong
    Intervention: Drug: Quetiapine
Pagsberg AK, Jeppesen P, Klauber DG, Jensen KG, Rudå D, Stentebjerg-Olesen M, Jantzen P, Rasmussen S, Saldeen EA, Lauritsen MB, Bilenberg N, Stenstrøm 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
July 2015
February 2015   (final data collection date for primary outcome measure)

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 trial and is briefly detained, confined, or subjected to other forceful treatment according to the Danish Psychiatric Care Act ('Psykiatriloven'), both the patient and parents have to agree to remain in the trial if exclusion is to be avoided. Compulsory treatment in the form of, e.g., brief forced immobilisation or single instances of forced medication, are not causes for exclusion.
  • 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.

Healthy volunteers - Inclusion Criteria:

  • 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.

Healthy volunteers - Exclusion Criteria:

  • 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.
Both
12 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01119014
TEAprotocolversion5-11 03 2010, 2009-016715-38
Yes
Anne Katrine Pagsberg, University of Copenhagen
Anne Katrine Pagsberg
  • The Psychiatric Centre for Children and Adolescents in Bispebjerg, Denmark
  • Psychiatric Centre Copenhagen, Denmark
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Albert Einstein College of Medicine of Yeshiva University
  • Research Institute for Biological Psychiatry, Sct. Hans Hospital, Denmark
  • Capital Region Pharmacy, Denmark
  • The Research Council for Health and Disease, Denmark
  • Allocated inheritance from Elizabeth Stevn and Niels Rindom, Denmark
  • AP Moeller Foundation
  • Tryg Fonden, Denmark
Principal Investigator: 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
University of Copenhagen
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP