Determinants of successful discontinuation of antipsychotics used for behavioural symptoms in people with intellectual disability

Determinants of successful discontinuation of antipsychotics used for behavioural symptoms in people with intellectual disability - DISCAP2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40740

Enrollment

200

Registered

2014-11-03

Start date

2015-01-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

challenging behaviour

Interventions

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.

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 Parkinsons 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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)