Skip to main content

Table 1 TEA RCT, schedule for outcome assessments during 12 weeks of blinded intervention

From: Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial

Assessments Inclusion (week 0) Follow-up (week 2) Follow-up (week 4) Follow-up (week 12)
Psychopathology and adverse reactions rating scales PANSS, DIPI, CGI-S, CGI-I, CGI-E, GAPD, UKU, AIMS, SAS, and BARS X X X X
Suicidal ideation K-SADS-PL specific items X X X X
Cognition, cognitive daily and executive function BACS, SCoRS-DK and BRIEF X    X
Somatic examination Standard clinical examination, blood pressure, pulse, weight, height, BMI, and abdominal circumference. X X X X
Health-related quality of life Questionnaire: KIDSCREEN-52 X    X
Laboratory tests (see list below) X   X X
  1. AIMS = Abnormal Involuntary Movement Scale; BACS = Brief Assessment of Cognition in Schizophrenia; BARS = Barnes Akathisia Rating Scale; BMI = Body Mass Index; BRIEF = Behavioural Rating Inventory of Executive Functions; CGI = Clinical Global Impression (-I = Improvement -S = Severity -E = Efficacy); DIPI = Dimensions of Psychosis Instrument; GAPD = Global Assessment of Psychosocial Disability; HRQoL = Health related quality of life; K-SADS-PL = Kiddie-SADS-Present and Lifetime Version; KIDSCREEN-52 = Health related quality of life questionnaire for children and young people and their parents; PANSS = Positive and Negative Syndrome Scale; SCoRS-DK = Schizophrenia Cognition Rating Scale – Danish version; UKU = ‘Udvalget for Kliniske Undersøgelser’ Side Effect Rating Scale.
  2. Laboratory tests: Blood tests (fasting): triglycerides; total cholesterol; high-density and low-density lipoproteins; glucose; insulin; prolactin; creatinphosphokinase; haemoglobin; leukocyte cell and differential count; thrombocyte cell count; sodium; potassium; creatinine; aspartate amino transferase; alkaline phosphatases; thyroid stimulating hormone; vitamin D; omega 3 fatty acids; genetic material (DNA). Blood samples to analyse serum values of antipsychotics are drawn at week 4 and 12, and saved for later analysis. Urine tests: pregnancy test (at baseline and at follow-up if suspicion of pregnancy), screening for medication and substance abuse (at baseline and at follow-up if suspicion of substance use). ECG: Standard leads.