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Table 1 Schedule of assessments

From: Antipsychotics withdrawal in adults with intellectual disability and challenging behaviour: study protocol for a multicentre double-blind placebo-controlled randomised trial

Methods / Week number 0 2 4 5 6 8 10 12 13 14 16 21 22 40
Withdrawal group (% AP withdrawal) 100 75    50   25    0    0 e
Control group (%) 100 100    100   100    100    100 e
Baseline questionnaire, e.g. participant characteristics X              
Questionnaires and interviewsa
 ABC, VAS, CGI, ADAMS, CLE, follow-up questionnaire X X X   X X X X   X X   X X
 Semi-structured interview X     X         X X
Psychiatric disordersb
 PAS-ADD X     X         X X
Movement disordersc
 Rating scales and video registration (SHRS and BARS) X     X         X X
 Electronic devices for measuring dyskinesia, bradykinesia, akathisia X     X         X X
Sleep
 Actiwatch X X   X X     X X   X   X
 Somnography X            X   
Physical symptomsd
 MEDS X     X         X X
 Heart rate, blood pressure, weight X X X   X X X X   X X   X X
 Waist circumference X             X X
 Height X              
 Lab: fasting glucose, triglycerids, cholesterol (total, HDL), cortisol, stored serum X             X  
 CYP2D6, risperidone or pipamperone serum levels X              
Epilepsy
 Seizure calendar for the last 6 months X             X X
  1. aABC, Aberrant Behaviour Checklist (Dutch version AGS); VAS, Visual Analogue Scale; CGI-I, Clinical Global Impression – Improvement scale; ADAMS, Anxiety, Depression and Mood Scale (Dutch version, ADESS); CLE, Checklist Life Events
  2. bPAS-ADD, Psychiatric Assessment Schedules for Adults with Developmental Disabilities
  3. cSHRS, St. Hans Ratings Scale; BARS, Barnes Akathisia Rating Scale
  4. dMEDS, Matson Evaluation of Drug Side effects
  5. efollow-up period, own team of physician and behavioural scientist determines further treatment: e.g. maintain the withdrawal, restart AP, maintain AP or start withdrawal if no discontinuation was done