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

Table 1 Schedule of assessments

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 interviews^a
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 disorders^b
PAS-ADD	X				X								X	X
Movement disorders^c
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 symptoms^d
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

^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
^bPAS-ADD, Psychiatric Assessment Schedules for Adults with Developmental Disabilities
^cSHRS, St. Hans Ratings Scale; BARS, Barnes Akathisia Rating Scale
^dMEDS, Matson Evaluation of Drug Side effects
^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

ISSN: 1471-244X