To investigate whether the occurrence and severity of neurological withdrawal symptoms during a discontinuation trajectory of antipsychotics used for challenging behaviours in people with intellectual disability is associated with achievement of…
ID
Source
Brief title
Condition
- Mental impairment disorders
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Behavioral parameters are scores of the five subscales of the Aberrant Behavior
Checklist (ABC) i.e., irritability, hyperactivity, lethargy, stereotypic
behavior and inappropriate speech, and of the Clinical Global Impression scale
Improvement (CGI-I).
Secondary outcome
Neurological parameters are scores of extrapyramidal symptoms as measured item
1 through 9 of the Abnormal Involuntary Movement Scale (AIMS), the Barnes
akathisia objective symptoms, subjective symptoms and burden scale scale, and
items 20, 21, 22, and 31 of the Unified Parkinson Scale (UPDRS). Autonomic
symptoms will be measured by the Scale for Outcomes in Parkinson*s
disease-Autonomic Symptoms (SCOPA-AUT).
To assess characteristics of caregivers we will use translated and validated
versions of the Challenging Behavior Self Efficacy Scale and the Emotional
reactions to challenging behavior scale . As far as we know there are no
instruments to measure knowledge and cognitions concerning physical,
psychological and behavioral effects of psychotropic drug use in caregivers of
individuals with intellectual disability. Therefore we will use a self-designed
questionnaire.
We will use the RAND-36 to assess health related quality of life and the
subscales *emotional-wellbeing* and *physical-wellbeing* of the quality of life
(QUOL) related personal outcomes scale (POS), which has been developed for use
in people with intellectual disabilities.
Background summary
People with intellectual disability (ID) frequently use long-term
antipsychotic drugs for challenging behaviours, although the efficacy in this
indication has not been proven. Moreover, antipsychotics may cause harmful side
effects, which may negatively influence quality of life. Especially
neurological side-effects may be serious and sometimes life threatening or
irreversible. In order to prevent iatrogenic damage caused by unnecessary
antipsychotic drug use discontinuation should be considered.
In daily practice successful discontinuation of antipsychotics may be hampered
by neurological withdrawal symptoms, which may remain clinically undiagnosed.
Withdrawal symptoms may cause distress and an increase in behavioural symptoms,
thus likely leading to higher dosage and ongoing use of the antipsychotic drug.
Also, staff- related factors like knowledge and cognitions of psychotropic drug
use and attitudes towards challenging behaviours of their clients may influence
a successful discontinuation trajectory.
Study objective
To investigate whether the occurrence and severity of neurological withdrawal
symptoms during a discontinuation trajectory of antipsychotics used for
challenging behaviours in people with intellectual disability is associated
with achievement of complete discontinuation.
To study staff-related factors which may be associated with achievement of
complete discontinuation of antipsychotics used for challenging behaviours in
people with intellectual disability.
To study the effect of discontinuation of antipsychotics used for challenging
behaviours on health related quality of life in people with intellectual
disability.
To study whether there is an association of severity of neurological side
effects of antipsychotics used for challenging behaviours with health related
quality of life in people with intellectual disability.
Study design
We will prospectively investigate factors that may be associated with
successful discontinuation of long-term used antipsychotics for challenging
behaviors as part of clinical practice of intellectual disability physicians or
general practitioners. Study settings are living facilities of care providing
organizations.
Intervention
Treatment of subjects:
Subjects will taper off long-term used antipsychotic drugs, prescribed on an
off-label base by lowering the dose every two weeks with 12.5% of the original
dose.
Study burden and risks
The risk associated with participation in this study are negligible, due to the
set of safety precautions, while the burden is minimal. It is obvious that
study of medication discontinuation in patients with intellectual disability
can only be performed in intellectually disabled participants.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Any sex or ethnicity
Age >= 6 years
Functioning below an IQ level of 70 as assessed by an authorized behavioral scientist
Subjects have used one or more antipsychotics for more than one year for challenging behavior
Subjects have been presented a treatment proposal of an attempt to discontinue antipsychotics by their physician.
Exclusion criteria
A history of schizophrenia, a bipolar disorder, or affective psychosis according to DSM IV or ICD-10 criteria
A history of unsuccessful withdrawal of antipsychotics in the past 6 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | EudraCT 2014-002686-30 |
| CCMO | NL50403.042.14 |