Anti-psychotic Drug Prescribing Patterns Within Specialist Adult ID Services in England and Wales
NCT ID: NCT06238089
Last Updated: 2024-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
600 participants
OBSERVATIONAL
2023-12-19
2024-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Psychiatric Orders in Psychoanalytic Treatment of ASD
NCT05930912
Antipsychotic Polypharmacy: Prevalence, Background and Consequences
NCT00541398
Characterization of the Use of Antipsychotics in PTSD During the Past Seven Years
NCT00230893
The Compliance Project Concerning People With Schizophrenia
NCT00497848
A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
NCT03809325
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Is it feasible to identify People with Intellectual Disabilities (PwID) who have been prescribed 2 or more anti-psychotic medications over 7 years retrospectively.
2. It is possible to obtain a complete data set for each patient identified and therefore be able to explore the prescribing patterns across the eight sites.
3. Is it feasible to quantify anti-psychotic treatment (APT) prescribing in PwID as chlorpromazine equivalent dose values across different healthcare Trusts in England and Wales.
Main objectives:
4. To explore yearly and overall prescribing patterns among PwID (with or without mental-health reasons (psychiatric co-morbidities)) in receipt of ≥2 forms of anti-psychotic treatment (multiple) over time?
5. How has multiple anti-psychotic treatment prescribing changed between 2017 and 2023 using chlorpromazine equivalent dose values, in PwID with mental health and no mental health indications?
6. What has been the impact of the COVID-19 pandemic (and corresponding lockdown restrictions in England and Wales) on multiple anti-psychotic treatment prescribing among PwID?
7. Can the NHS England Statistical Process Control tool (SPC) be utilised to track yearly anti-psychotic treatment prescribing among PwID receiving multiple forms of anti-psychotic treatment, and monitor variation between services (sites) and patient groups (e.g. psychiatric co-morbidities; challenging behaviour).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Eligible patients who have had a psychiatric review by specialist adult ID services in 2017.
Adults with an intellectual disability who are under the care of ID services in receipt of \>2 oral and/or long-acting intra-muscular (IM) injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2017.
No interventions assigned to this group
Eligible patients who have had a psychiatric review by specialist adult ID services in 2018.
Adults with an intellectual disability who are under the care of ID services in receipt of \>2 oral and/or long-acting IM injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2018.
No interventions assigned to this group
Eligible patients who have had a psychiatric review by specialist adult ID services in 2019.
Adults with an intellectual disability who are under the care of ID services in receipt of \>2 oral and/or long-acting IM injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2019.
No interventions assigned to this group
Eligible patients who have had a psychiatric review by specialist adult ID services in 2020.
Adults with an intellectual disability who are under the care of ID services in receipt of \>2 oral and/or long-acting IM injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2020.
No interventions assigned to this group
Eligible patients who have had a psychiatric review by specialist adult ID services in 2021.
Adults with an intellectual disability who are under the care of ID services in receipt of \>2 oral and/or long-acting IM injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2021.
No interventions assigned to this group
Eligible patients who have had a psychiatric review by specialist adult ID services in 2022.
Adults with an intellectual disability who are under the care of ID services in receipt of \>2 oral and/or long-acting IM injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2022.
No interventions assigned to this group
Eligible patients who have had a psychiatric review by specialist adult ID services in 2023.
Adults with an intellectual disability who are under the care of ID services in receipt of \>2 oral and/or long-acting IM injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2023.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient has a diagnosis of ID
* Patient under the care of specialist adult ID services
* Patient on \>2 anti-psychotic treatments (oral and IM injectable (depots))
Exclusion Criteria
* Under the age of 18 years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Plymouth
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Professor Rohit Shankar
Professor in Neuropsychiatry
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Professor Shankar
Role: PRINCIPAL_INVESTIGATOR
University of Plymouth
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cheshire and Wirral Partnership NHS Foundation Trust
Chester, , United Kingdom
Coventry and Warwickshire Partnership NHS Trust
Coventry, , United Kingdom
Hertfordshire Partnership University NHS Foundation Trust
Hatfield, , United Kingdom
Leicestershire Partnership NHS Trust
Leicester, , United Kingdom
Central and North West London NHS Foundation Trust
London, , United Kingdom
North East London NHS Foundation Trust
London, , United Kingdom
Cornwall Partnership NHS Foundation Trust
Redruth, , United Kingdom
Swansea Bay University Health Board
Swansea, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Branford D, Shankar R. Antidepressant prescribing for adult people with an intellectual disability living in England. Br J Psychiatry. 2022 Aug;221(2):488-493. doi: 10.1192/bjp.2022.34.
Howkins J, Hassiotis A, Bradley E, Levitas A, Sappok T, Sinai A, Thakur A, Shankar R. International clinician perspectives on pandemic-associated stress in supporting people with intellectual and developmental disabilities. BJPsych Open. 2022 Apr 18;8(3):e84. doi: 10.1192/bjo.2022.49.
Tromans S, Kinney M, Chester V, Alexander R, Roy A, Sander JW, Dudson H, Shankar R. Priority concerns for people with intellectual and developmental disabilities during the COVID-19 pandemic. BJPsych Open. 2020 Oct 29;6(6):e128. doi: 10.1192/bjo.2020.122.
Naqvi D, Perera B, Mitchell S, Sheehan R, Shankar R. COVID-19 pandemic impact on psychotropic prescribing for adults with intellectual disability: an observational study in English specialist community services. BJPsych Open. 2021 Dec 6;8(1):e7. doi: 10.1192/bjo.2021.1064.
Leucht S, Samara M, Heres S, Davis JM. Dose Equivalents for Antipsychotic Drugs: The DDD Method. Schizophr Bull. 2016 Jul;42 Suppl 1(Suppl 1):S90-4. doi: 10.1093/schbul/sbv167.
Patel MX, Arista IA, Taylor M, Barnes TR. How to compare doses of different antipsychotics: a systematic review of methods. Schizophr Res. 2013 Sep;149(1-3):141-8. doi: 10.1016/j.schres.2013.06.030. Epub 2013 Jul 8.
Shankar R, Wilcock M, Deb S, Goodey R, Corson E, Pretorius C, Praed G, Pell A, Vujkovic D, Wilkinson E, Laugharne R, Axby S, Sheehan R, Alexander R. A structured programme to withdraw antipsychotics among adults with intellectual disabilities: The Cornwall experience. J Appl Res Intellect Disabil. 2019 Nov;32(6):1389-1400. doi: 10.1111/jar.12635. Epub 2019 Jun 13.
Mehta H, Glover G. Psychotropic drugs and people with learning disabilities or autism, 2019. Public Health England.
National Health Service. Stopping over medication of people with a learning disability, autism or both (STOMP). NHS England " Stopping over medication of people with a learning disability, autism or both (STOMP) [Accessed 15th December 2023).
Taylor DM, Barnes TR and Young AH. The Maudsley prescribing guidelines in psychiatry. 13th ed. West Sussex: Wiley-Blackwell; 2018.
National Health Service. Statistical process control tool. https://www.england.nhs.uk/statisticalprocess-control-tool/ [Accessed 15th December 2023].
Stanyard E, Neilens H, Allgar V, Bailey M, Musicha C, Purandare K, Perera B, Roy A, Sawhney I, Watkins L, Jaydeokar S, Lennard S, Mitchell S, McGowan P, Laugharne R, Tromans SJ, Shankar R. A novel way to understand and communicate the burden of AntiPsycHotic prescribing for adults across specialist Intellectual Disability services in England and Wales: the APHID feasibility study protocol. Front Health Serv. 2025 May 9;5:1393805. doi: 10.3389/frhs.2025.1393805. eCollection 2025.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TRUST/VC/AC/SG/6328-9580
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
331470
Identifier Type: OTHER
Identifier Source: secondary_id
4548
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.