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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Copenhagen
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: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Psychosis
Drug: Aripiprazole
Drug: Quetiapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Psychopathology: improvement on PANSS positive scale (PANSS 'Positive and Negative Syndrome Scale') [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 300
Study Start Date: May 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripirazole Drug: Aripiprazole
pill, 2,5-20 mg/day, maximum 16 weeks
Experimental: Quetiapine prolong Drug: Quetiapine
pill, 50-600mg/day, maximum 16 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119014

Contacts
Contact: Katrine Pagsberg, MD, PhD +45 26253924 Anne.Katrine.Pagsberg@regionh.dk
Contact: Anders Fink Jensen, MD, DMSci Anders.Fink-Jensen@regionh.dk

Locations
Denmark
Aalborg Psychiatric Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Hans-Christoph Steinhausen, MD.    +45 96 31 15 01    psyk.afd.a@rn.dk   
Principal Investigator: Hans-Christoph Steinhausen, MD.         
Sub-Investigator: Ditte Rudå, MD.         
Aalborg Psychiatric Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Marlene Briciet Lauritsen, MD.    +45 40234112    marlene.lauritsen@rn.dk   
Principal Investigator: Marlene Briciet Lauritsen         
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Anne Katrine Pagsberg, MD, Ph.D.    +45 3531 2650    Anne.Katrine.Pagsberg@regionh.dk   
Principal Investigator: Anne Katrine Pagsberg, MD, Ph.D.         
Sub-Investigator: Ditte Rudå, MD.         
Sub-Investigator: Karsten Gjessing Jensen, MD.         
Sub-Investigator: Dea Klauber, MSc         
Psychiatric Centre Copenhagen, Rigshospitalet Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Anders Fink-Jensen, MD, DMSci    +45 35456210    anders.fink-jensen@rh.regionh.dk   
Principal Investigator: Anders Fink-Jensen, MD, DMSci         
Glostrup Hospital Recruiting
Glostrup, Denmark, 2600
Contact: Pia Jeppesen, MD, Ph.D    +45 43 23 48 57    Pia.Jeppesen@regionh.dk   
Principal Investigator: Peter Jantzen, MD         
Hillerød Hospital Recruiting
Hillerød, Denmark, 3400
Contact: Maj-Britt Lauritsen, MD    +4538646572    Maj-Britt.Lauritsen@regionh.dk   
Principal Investigator: Maj-Britt Lauritsen, MD,         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Niels Niels Bilenberg, MD    +45 6311 7102    niels.bilenberg@ouh.regionsyddanmark.dk   
Principal Investigator: Niels Bilenberg, MD         
Psychiatric Hospital for Children and Adolescents, Aarhus Recruiting
Risskov, Denmark, 8240
Contact: Per Hove-Thomson, MD, D.M.Sci.    +45 77 89 40 00    buc.kontakt@rm.dk   
Principal Investigator: Per Hove-thomson, MD, D.M.Sci.         
Child and Adolescent Psychiatric Department, Region Zealand Recruiting
Roskilde, Denmark, 4000
Contact: Jesper Pedersen, MD       jpee@regionsjaelland.dk   
Principal Investigator: Jesper Pedersen, MD         
Sub-Investigator: Louise Nyvang, MD         
Psychiatric Centre Sct. Hans Not yet recruiting
Roskilde, Denmark, 4000
Contact: Thomas Werge, Ph.D.    +45 4633 4968    thomas.werge@regionh.dk   
Principal Investigator: Thomas Werge, P.hD.         
Sponsors and Collaborators
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
Investigators
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
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne Katrine Pagsberg, MD., PhD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01119014     History of Changes
Other Study ID Numbers: TEAprotocolversion5-11 03 2010, 2009-016715-38
Study First Received: May 3, 2010
Last Updated: August 6, 2013
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Aripiprazole
Quetiapine
Psychosis
Child
Adolescent

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Aripiprazole
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 16, 2014