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Anti-psychotic drug reduction in primary care for adults with learning disabilities

ANDREA-LD: ANti-psychotic Drug REduction in primary care for Adults with Learning Disabilities (ANDREA-LD): a randomised double-blind placebo-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38126962
Enrollment
310
Registered
2013-04-08
Start date
2013-11-01
Completion date
Unknown
Last updated
2018-08-27

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

Conditions

Learning disabilities Mental and Behavioural Disorders Developmental disorder of scholastic skills, unspecified

Interventions

Participants will be taking either risperidone or haloperidol at the start of the study. They will then be randomised to either the dose reduction arm or the treatment as normal arm. Those in the dose

Sponsors

Cardiff University (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 or over 2. Have a learning disability as judged by administrative classification (e.g. on practice learning disability register, in receipt of an annual learning disability health check, in receipt of learning disability services) and a score on the Adaptive Behaviour Scale that converts to an estimated IQ of 70 or below using the method described by Moss and Hogg 3. Currently prescribed one of two anti-psychotic drugs, haloperidol or risperidone, for treatment of challenging behaviour

Exclusion criteria

Exclusion criteria: 1. Current diagnosis of psychosis 2. Known recurrence of psychosis following previous drug reduction in the past 3 years 3. The clinician responsible for their treatment judges for any other reason that the participation in a drug reduction programme may be counter-indicated.

Design outcomes

Primary

MeasureTime frame
Aggression, evaluated using the Modified Overt Aggression Scale (MOAS). The MOAS rates four categories of aggression (verbal aggression, destruction of property, self-mutilation and physical aggression to others) measured at baseline, 6 months, 9 months and 12 months.

Secondary

MeasureTime frame
1. Adaptive behaviour, measured using the Adaptive Behaviour Scale (ABS) at screening 2. Mental health, measured using the Psychiatric Assessment Schedule for Adults with Developmental Disability Checklist (PAS-ADD) at screening, baseline, 6 months, 9 months and 12 months 3. Adverse effects of psychotropic medication, measured using the Udvalg for Kliniske Undersøgelser scale (UKU) at baseline and 9 months 4. Movement disorders, measured using the Dyskinesia Identification System Condensed User Scale (DISCUS) at baseline and 9 months 5. Other challenging behaviour, measured using the Aberrant Behaviour Checklist (ABC) at baseline, 6 months, 9 months and 12 months 6. Costs, measured using the Client Service Receipt Inventory [modified] (CSRI) at baseline, 6 months, 9 months and 12 months

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026