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Table 1 Schedule of events

From: Glutamatergic medication in the treatment of obsessive compulsive disorder (OCD) and autism spectrum disorder (ASD) – study protocol for a randomised controlled trial

Study period (SP) SP I (screening/ washout) SP II (double-blind treatment) SP III (down-titration)   
Visit number: 1 2 3 4 5 6 7 8 9 10 Unscheduled visitsa Early discontinuation
(End of) week: −2 −1 0 1 2 4 6 8 12 13   
Suggested time to next visit (days): 7 7 7 7 14 14 14 28 7    
Allowable time to next visit (days): 5–9 5–9 5–9 5–9 10 - 18 10–18 10–18 24–32 5–9    
Clinical assessments:
 Informed consent/assent X            
 Psychiatric assessment X            
 Systematic Interview, e.g. DISC (OCD group) X            
 Systematic Interview, e.g. DISC (re co-morbidities): ODD, CD, tic domains (all patients) X            
 ADI-R short version, (ASD group) X            
 WIS-C (4 subtests) X            
 Inclusion/exclusion criteria X X X          
 Randomisation to active drug vs. placebo    X          
 Demographics X            
 Physical examination X            
 Medical history X            
 Discontinuation of prohibited medications X            
 Height, weight, vital signs X         X    X
 Clinical laboratory testsb,c, X   Xc    X    Xc   (X)a Xc
 Serum and urine pregnancy testd X            
 Urine drug screen X           (X)a X
 Urine analysis X   X    X    X    X
 Biomarkers    X          
 Genetics    X          
 Physical Development Scale    X       X    
 CGI-S X   X X X X X X X X   X
 CGI-I     X X X X X X X   X
 C-GAS    X    X    X    X
 CBCL, 6–18    X          
 CY-BOCS    X X X X X X X X (X)a X
 Children’s Social Behaviour Questionnaire    X X X X X X X X (X)a X
 Repetitive Behaviour Scale-Revised (RBS-R),    X X X X X X X X (X)a X
 CHIP-CE/AE    X    X    X    X
 PAERS    X X X X X X X X X X
 Neuropsychological test battery    X       X    X
 Neuroimaging assessments    X       X    
 AE monitoring   X X X X X X X X X X X
 Concomitant medications X X X X X X X X X X X X
 Eligibility to remain in study   X X X X X X X X X X X
 Study drug dispensed    X X X X X X X    
 Study drug returned     X X X   X X X   X
  1. alaboratory tests, ECG, etc. at unscheduled visits (due to AEs) according to the discretion of the investigator
  2. bpatients with significant increase after baseline (visit 3) in AST, ALT, total bilirubin, or AP from the upper limit of the lab reference range will have additional lab testing and/or consultation
  3. cto be collected in a fasting state at visits 3 and 9 (and early discontinuation, if possible); fasting defined as at least 8 hours with water as the only oral consumption
  4. dfemales of child-bearing potential only; additional pregnancy tests possible at each visit at the discretion of the investigator
  5. AE adverse event, ASD autism spectrum disorders, AST aspartate aminotransferase, ALT alanine aminotransferase, AP alkaline phosphatase, CBCL Child Behaviour Checklist, C-GAS Children’s Global Assessment, CGI-I, Clinical Global Impression-Improvement, CGI-S Clinical Global Impression-Severity, CHIP-CE/AE Child Health and Illness Profile, CY-BOCS Children’s Yale-Brown Obsessive-Compulsive Scale, DISC Diagnostic Interview for Children, ECG electrocardiography, OCD obsessive-compulsive disorder, PAERS Pediatric Adverse Event Rating Scale