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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21589

Enrollment

200

Registered

2015-11-04

Start date

2015-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

off-label use

Interventions

discontinuation of long-term used antipsychotics for behavioural symptoms whereby dosereduction will take place every two weeks with appr. 12.5 % of baseline dosage in a time schedule of 14 weeks

Eligibility

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. Written informed consent of the legal representative.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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 • Use of risperidone

Design outcomes

Primary

Measure	Time frame
Achievement of complete discontinuation at the time point of 16 weeks (two weeks after the study discontinuation schedule)	—

Secondary

Measure	Time frame
Achievement of complete discontinuation at the time points of 28 weeks and 40 weeks. Behaviour: The five subscales of the Aberrant Behavior Checklist (ABC) i.e., irritability, hyperactivity, lethargy, stereotypic behavior and inappropriate speech, and the Clinical Global Impression scale Improvement (CGI-I). Neurological symptoms: 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). Characteristics of caregivers: Translated and validated versions of the Challenging Behavior Self Efficacy Scale and the Emotional reactions to challenging behavior scale Quality of life: RAND 36 The subscales “emotional-wellbeing” and “physical-wellbeing” of the quality of life (QUOL) related personal outcomes scale (POS),	—

Measure

Time frame

Achievement of complete discontinuation at the time points of 28 weeks and 40 weeks. Behaviour: The five subscales of the Aberrant Behavior Checklist (ABC) i.e., irritability, hyperactivity, lethargy, stereotypic behavior and inappropriate speech, and the Clinical Global Impression scale Improvement (CGI-I). Neurological symptoms: 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). Characteristics of caregivers: Translated and validated versions of the Challenging Behavior Self Efficacy Scale and the Emotional reactions to challenging behavior scale Quality of life: RAND 36 The subscales “emotional-wellbeing” and “physical-wellbeing” of the quality of life (QUOL) related personal outcomes scale (POS),

—

Contacts

Public ContactGerda Kuijper de

Centrum Verstandelijke Beperking en Psychiatrie/GGZ Drenthe

gerda.de.kuijper@ggzdrenthe.nlphone: (+31)0592-334100

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)