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. MedDRA version: 16.1 Level: LLT Classification code 10032314 Term: Other nonorganic psychoses System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 16.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 16.1 Level: LLT Classification code 10004916 Term: Bipolar
Conditions
Interventions
Product Name: Quetiapine extended release
Pharmaceutical Form: Tablet
INN or Proposed INN: QUETIAPINE
CAS Number: 111974697
Other descriptive name: Quetiapine extended release
Concentration unit: mg
Sponsors
University of Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: • 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 or only have received a limited amount of treatment with antipsychotics previously. As a maximum, the treatment with antipsychotics for a psychotic illness must have been within the previous calendar year, or, maximum one week’s treatment (lifetime, regardless of time). • Somatic illness: No somatic contraindication to planned medication, documented by standard somatic examination • Written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: 200 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients: • 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). A pregnancy test (urine sample) is also taken throughout the trial if suspicion of pregnancy is present, e.g., if the participant is changing status from not sexually active to sexually active. • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Examine the efficacy of antipsychotics in children and adolescents between 12-17 years of age with psychosis; the effect is measured as: a. psychopathology, primary outcome measure of interest: Severity of psychotic symptoms (PANSS positive subscale); b. cognitive deficits, primary outcome measure of interest: Global BACS cognitive score; c. cognitive daily functioning, primary outcome measure of interest: Global executive function, SCoRS-DK. Examine the tolerability of antipsychotics in children and adolescents between 12-17 years of age with psychosis, concerning: a. motor adverse reactions; b. metabolic adverse reactions; c. hormonal adverse reactions; d. cardiac adverse reactions; e. other side effects, including psychological ;Secondary Objective: Identify early indicators (after 2 and 4 weeks of treatment with two different atypical antipsychotics) of sustained clinically significant effects on psychopathology assessed after 12 weeks and after one year after inclusion into the trial. Additionally, we will investigate health-related quality of life after antipsychotic treatment for psychosis, and the perception of stigmatisation following a psychotic illness. Additionally, we will examine primary and secondary motion patterns and the development of aripiprazole- or quetiapine-induced, secondary motion patterns using KinectTM (Microsoft Xbox) and Kinect Windows Software Development Kit. ;Primary end point(s): Psychopathology: PANSS positive scale (PANSS ‘Positive and Negative Syndrome Scale’);Timepoint(s) of evaluation of this end point: primary timepoint 12 weeks 2, 4, 12, and 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Psychopathology • Other PANSS scales (negative scale and general symptoms) • DIPI (Dimensions of Psychosis Instrument) (Mizrahi et al., 2006); • CGI-S (Clinical Global Impression Severity) (Guy, 1976); • CGI-I (Clinical Global Impression Improvement) (Guy, 1976); • CGI-Efficacy (Clinical Global Impression Efficacy) (Guy, 1976) • GAPD (Global Assessment of Psychosocial Disability) (World Health Organization, 1993). Cognition • Cognition: BACS Global Score (Brief Assessment of Cognition in Schizophrenia) (Keefe et al., 2004); • Cognitive daily functioning: Global functioning from SCoRS-DK (Schizophrenia Cognition Rating Scale, Danish version) (Keefe et al., 2006); • Global executive functioning measured with BRIEF (Behavioural Rating Inventory of Executive Functions) (Gioia, G.A. 2005). • Other secondary outcomes are attention, executive functions and memory from BACS as well as specific sub-outcomes from SCoRS-DK and BRIEF. Adverse reactions • UKU side effect scale (‘Udvalget for Kliniske Undersøgelser’ Side Effect Rating Scale) (Lingjaerde et al., 1987); • AIMS (Abnormal Involuntary Movement Scale) (Guy W., 1976); • SAS (Simpson Angus Scale) (Simpson and Angus, 1970); • BARS (Barens Akathisia Rating Scale) (Barnes T.R.E., 1989); • KinectTM- based instrument • Other adverse events, i.e., any untoward occurrences including: o cardiac adverse reactions effects such as prolonged QT- interval o somatic events (blood pressure, pulse, weight, height, BMI and abdominal circumference); and o abnormal laboratory test results (lipid status, metabolic changes, other general blood tests according to clinical guidelines for clinical practice, and ECG). Suicidal ideation • K-SADS-PL, specific questions for depressive disorders (current) recurring thought of death, suicidal thoughts, suicidal action level of serious, suicidal action level of life-threatening, non-suicidal physical self-inflicted harm. Genetic and antipsychotic laborato | — |
Countries
Denmark
Contacts
Public ContactCentre for Psychiatry
University of Copenhagen
Outcome results
None listed