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

October 2, 2014 updated by: Anne Katrine Pagsberg

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aalborg, Denmark, 9000
        • Aalborg Psychiatric Hospital
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital
      • Copenhagen, Denmark, 2100
        • Psychiatric Centre Copenhagen, Rigshospitalet
      • Glostrup, Denmark, 2600
        • Glostrup Hospital
      • Hillerød, Denmark, 3400
        • Hillerød Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital
      • Risskov, Denmark, 8240
        • Psychiatric Hospital for Children and Adolescents, Aarhus
      • Roskilde, Denmark, 4000
        • Child and Adolescent Psychiatric Department, Region Zealand
      • Roskilde, Denmark, 4000
        • Psychiatric Centre Sct. Hans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aripirazole
pill, 2,5-20 mg/day, maximum 16 weeks
Experimental: Quetiapine prolong
pill, 50-600mg/day, maximum 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychopathology: improvement on PANSS positive scale (PANSS 'Positive and Negative Syndrome Scale')
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychopathology
Time Frame: 12 weeks
Psychopathology (other PANSS scales, DIPI, SGI-S, CGI-I,and GAPD).
12 weeks
Cognition
Time Frame: 12 weeks
Cognition and functioning (BACS Global Score, SCoRS-DK, Schizophrenia Cognition Rating Scale, BRIEF)
12 weeks
Adverse reactions
Time Frame: 12 weeks
Adverse reactions (UKU side effect scale, AIMS, SAS, BARS, and other adverse events)
12 weeks
Suicidal ideation
Time Frame: 12 weeks
Suicidal ideation (K-SADS-PL, specific questions for depressive disorders (current)
12 weeks
Genetic and antipsychotic laboratory tests
Time Frame: 12 weeks
Genetic variants affecting metabolism of antipsychotics
12 weeks
Prognostic factors
Time Frame: 12 weeks
Prognostic factors (DUP, and PAS)
12 weeks
Quality of Life
Time Frame: 52 weeks
Quality of Life (measured with Kidscreen)
52 weeks
Stigmatization
Time Frame: 52 weeks
Qualitative interviews
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 7, 2010

Study Record Updates

Last Update Posted (Estimate)

October 3, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

October 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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