The primary objective of this study is: To study the effect of controlled discontinuation of long-term used risperidone, for the treatment of challenging behavior, on behaviour and health. Our hypothesis is that long-term use of risperidone for…
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end point is behaviopr meassured by the irritability subscale of
the Aberrant Behaviour Checklist (ABC). The ABC was developed to
assess (pharmaceutical) treatment effects on the challenging behaviors of
people with intellectual disability (35-37). The ABC has 58 items divided over
five subscales i.e., irritability (15 items), lethargy (16 items), stereotypic
behavior (7 items), hyperactivity (16 items) and inappropriate speech (4
items).
Secondary outcome
Secondary study parameters are:
- Other ABC subscales
- Clinical Global Impression Scale (CGI)
- Abnormal Involuntary Movement Scale (AIMS)
- Barnes Akathisia Rating Scale (BARS)
- Unified Parkinsons Disease Rating Scale (UPDRS)
- Scales for Outcomes in Parkinson's disease AUTonomic symptoms (SCOPA-AUT)
- Epworth Sleepiness Scale (ESS)
- Personal Outcome Scale (POS)
- RAND-36
- Physical measures: length, weight, waist circumference, heart rate and blood
pressure
- Blood counts
From a blood draw, we will obtain measures on:
- Metabolism: fasting glucose, insulin, triglycerides, high-density
lipoproteins (HDL), low-density lipoproteins (LDL), leptine, total
cholesterol, and HbA1C.
- Endocrine parameters: prolactin, testosterone
- Bone turnover: P1NP, CTx, osteocalcine, vitamin D, and calcium.
- Thyroid function: TSH, T4, and parathyreoid hormone.
- Pharmacokinetics: risperidone and 9-hydroxyrisperidone concentrations.
- Albumine, creatine, potasium and sodium levels.
Predictor variables:
- Demographic data and socio-economic status
- Treatment history and psychiatric diagnosis
- Tanner stages of pubertal development predictor variables for caregivers:
- Challenging Behavior Self-Efficacy Scale
- the Emotional Reactions to Challenging Behavior Scale
- knowledge of psychotropic drugs
- beliefs of caregivers
Background summary
Over the past decades, risperidone has been prescribed widely among people with
intellectual disability and challenging behavior. Even though risperidone only
has a licensed indication for the short term treatment of challenging behavior,
prescriptions are often for long term. There is still a lack of evidence for
the effectiveness of long term used risperidone for challenging behavior.
Moreover, the long-term use op risperidone may have considerable health
effects, such as extrapyramidal symptoms, metabol syndrome, obesitas, and later
on in life diabetes and osteoporosis. Among children/adolescents with an
intellectual disability these health effects may influence their development en
growth. Furthermore, research suggests that discontinuation is possible and
results in improved behavior and health outcomes. This study is aimed to
further investigate the effects on behavior, physical health and quality of
life of discontinuation of long-term used risperidone in people with
intellectual disability and challenging behavior.
Study objective
The primary objective of this study is: To study the effect of controlled
discontinuation of long-term used risperidone, for the treatment of challenging
behavior, on behaviour and health. Our hypothesis is that long-term use of
risperidone for challenging behaviour is not more effective than a placebo.
The study has the following secondary objectives tested for both children and
adolescents and adults:
1) To study the effect of controlled discontinuation on physical health
parameters, including physical parameters of side-effects.
2) To study the effect of controlled discontinuation of risperidone on
Health-related Quality of Life (HQoL).
3) To study whether there is an association between HQoL and severity of
challenging behaviour and physical health parameters.
4) To study the predictors of successful discontinuation.
5) To compare the effectiveness of long-term used risperidon between children
and adults.
6) To compare the effects of discontinuation on health paramaters between
adults and children
7) To compare the effects of discontinuation on quality of life.
Study design
A double-blinded randomized placebo-controlled multicenter discontinuation
trial.
Intervention
The participants will be randomized in a 1:1 ratio to either ongoing use of
risperidone or gradual discontinuation to placebo in a period of 14 weeks.
Trial medication will be used by both groups until the moment of deblinding 24
weeks after baseline. Physical examinations and data collection will take place
at baseline and week 6, 10, 14, 18 and 24. Blood sampling will take place at
baseline and week 24. Forty-two weeks after baseline a natural follow-up will
be scheduled.
Study burden and risks
All participants of this study have used risperidone for at least one year. For
that reason the study does not bring any additional health risks. Venipuncture
(2 times, 30 ml each) may cause an extra burden on participants. However there
is a risk for a possible detoriation in behavior. Risks will be moderate and
physical discomfort mild. The research protocol includes the participation of
people with intellectual disability as this study aims to study the effect of
discontinuation after the long-term use of risperidone in people with
intellectual disability.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
1. IQ lower then 70 as assessed by an authorized behavioral therapist
2. Age over 6 years
3. No history of chronic psychosis
4. Risperidone use over1 year
5. Challenging behavior was the reason of prescription of risperidone
6. Informed consent obtained from legal representative
Exclusion criteria
1. A history of schizofrenia, a bipolar disorder, or affective psychosis according to DSM IV or ICD-10 criteria
2. A history of unsuccessful withdrawal of antipsychotics in the past 6 months
3. The use of other antipsychotics in addition to risperidone use
4. Risperidone is administered as long-acting injections
5. Clients that do not receive 24 hour/a day care (by either a service provider or parents/family)
6. Clients that are pregnant or intention to become pregnant
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-003718-10-NL |
| CCMO | NL53217.042.15 |
| OMON | NL-OMON27969 |