Is risperidone effective in reducing challenging behaviours in individuals with intellectual disabilities after 1 year or longer use? A placebo-controlled, randomised, double-blind discontinuation study.
Adolescent
Adult
Aged
Antipsychotic Agents
/ administration & dosage
Child
Double-Blind Method
Drug Administration Schedule
Female
Humans
Intellectual Disability
/ drug therapy
Irritable Mood
/ drug effects
Male
Middle Aged
Outcome Assessment, Health Care
Problem Behavior
Risperidone
/ administration & dosage
Stereotyped Behavior
/ drug effects
Young Adult
challenging behaviour
discontinuation
intellectual disability
risperidone
side effects
Journal
Journal of intellectual disability research : JIDR
ISSN: 1365-2788
Titre abrégé: J Intellect Disabil Res
Pays: England
ID NLM: 9206090
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
15
03
2018
revised:
21
09
2018
accepted:
01
12
2018
pubmed:
5
1
2019
medline:
25
8
2020
entrez:
5
1
2019
Statut:
ppublish
Résumé
Many people with intellectual disabilities use risperidone long term for the management of challenging behaviours, despite its limited proof of effectiveness and its clear association with adverse events. Therefore, this study aimed to investigate the effectiveness of ongoing treatment with risperidone in reducing challenging behaviours versus controlled discontinuation on behaviour and health parameters. This was a placebo-controlled, double-blind, randomised discontinuation trial of risperidone. In the discontinuation group, risperidone was gradually replaced by a placebo over 14 weeks, while the control group maintained their existing dosage. Eight weeks after discontinuation, behaviour (as measured by the 'Aberrant Behavior Checklist') and health parameters (dyskinesia, akathisia, parkinsonism, weight, waist circumference, sedation and laboratory outcomes) were compared in both groups. A total of 25 participants were included in the trial, of which 11 were randomised into the discontinuation group and 14 were randomised into the continued treatment group. In the discontinuation group, 82% completely withdrew from risperidone. There was no significant change in irritability, compared with the continuation group, although there was a Group*Time effects on stereotypical behaviour in favour of the continuation group. Significant Group*Time effects were also found for weight, waist, body mass index, prolactin levels and testosterone levels, with beneficial effects for the discontinuation group. Discontinuation of long-term risperidone for reducing challenging behaviours is possible, without an increase in irritability. Discontinuation of risperidone may have beneficial effects on weight, waist circumference, prolactin levels and testosterone levels. The study suffered from difficulties in achieving the required sample size, which affected study power and generalizability.
Sections du résumé
BACKGROUND
Many people with intellectual disabilities use risperidone long term for the management of challenging behaviours, despite its limited proof of effectiveness and its clear association with adverse events. Therefore, this study aimed to investigate the effectiveness of ongoing treatment with risperidone in reducing challenging behaviours versus controlled discontinuation on behaviour and health parameters.
METHOD
This was a placebo-controlled, double-blind, randomised discontinuation trial of risperidone. In the discontinuation group, risperidone was gradually replaced by a placebo over 14 weeks, while the control group maintained their existing dosage. Eight weeks after discontinuation, behaviour (as measured by the 'Aberrant Behavior Checklist') and health parameters (dyskinesia, akathisia, parkinsonism, weight, waist circumference, sedation and laboratory outcomes) were compared in both groups.
RESULTS
A total of 25 participants were included in the trial, of which 11 were randomised into the discontinuation group and 14 were randomised into the continued treatment group. In the discontinuation group, 82% completely withdrew from risperidone. There was no significant change in irritability, compared with the continuation group, although there was a Group*Time effects on stereotypical behaviour in favour of the continuation group. Significant Group*Time effects were also found for weight, waist, body mass index, prolactin levels and testosterone levels, with beneficial effects for the discontinuation group.
CONCLUSION
Discontinuation of long-term risperidone for reducing challenging behaviours is possible, without an increase in irritability. Discontinuation of risperidone may have beneficial effects on weight, waist circumference, prolactin levels and testosterone levels. The study suffered from difficulties in achieving the required sample size, which affected study power and generalizability.
Substances chimiques
Antipsychotic Agents
0
Risperidone
L6UH7ZF8HC
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
418-428Informations de copyright
© 2019 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.