Intellectual DisabilityAPHIDNCT06238089
Anti-psychotic Drug Prescribing Patterns Within Specialist Adult ID Services in England and Wales
An observational study of Intellectual Disability, run by University of Plymouth at 8 sites in United Kingdom.
Trial summary
The overall aim of this observational study is to establish the anti-psychotic prescribing patterns across specialist intellectual disability (ID) services in England and Wales by collecting cross-sectional retrospective data at 7 annual time-points (1st July) from 2017 to 2023. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intellectual Disability
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 600 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 19 Dec 2023to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Intellectual Disabilities under the care of ID services in receipt of >2 oral and/or long-acting IM injectable anti-psychotic treatments (depots).
Who may be able to join
- Patient had psychiatric review by specialist adult ID services in the last year (e.g. for a patient to be included at 1st June 2017, data to be recorded from the most recent psychiatric review within the period between 1st January 2017 - 31st December 2017).
- 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))
Who cannot join
- Patients treated with Clozapine
- Under the age of 18 years
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites, 8 recruiting
- Recruiting
Cheshire and Wirral Partnership NHS Foundation Trust
Chester
Sujeet Jaydeokar
- Not yet recruiting
Coventry and Warwickshire Partnership NHS Trust
Coventry
Ashok Roy
- Not yet recruiting
Hertfordshire Partnership University NHS Foundation Trust
Hatfield
Indermeet Sawhney
- Recruiting
Leicestershire Partnership NHS Trust
Leicester
Samuel Tromans
- Recruiting
Central and North West London NHS Foundation Trust
London
Kiran Purandare
- Not yet recruiting
North East London NHS Foundation Trust
London
Bhathika Perera
- Not yet recruiting
Cornwall Partnership NHS Foundation Trust
Redruth
Richard Laugharne
- Recruiting
Swansea Bay University Health Board
Swansea
Lance Watkins
About this study
Official title: A Novel Way to Understand and Communicate the Burden of Antipsychotic Prescribing for Adults Across Specialist Intellectual Disability Services in England and Wales.
The overall aim of this observational study is to establish the anti-psychotic prescribing patterns across specialist intellectual disability (ID) services in England and Wales by collecting cross-sectional retrospective data at 7 annual time-points (1st July) from 2017 to 2023.
Read the detailed description
Feasibility protocol objectives:
- Is it feasible to identify People with Intellectual Disabilities (PwID) who have been prescribed 2 or more anti-psychotic medications over 7 years retrospectively.
- 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.
- 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:
- 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?
- 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?
- 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?
- 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
- Intellectual Disability
- Keywords
- Intellectual Disability, Learning Disability, Anti-psychotic treatments, Over-prescribing, Psychotropic
- Medical subject headings
- Intellectual Disability, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences in chlorpromazine equivalent dose values in PwID prescribed multiple anti-psychotic treatment across the 7-annual timepoints and across the 8 sites.
Main objective: 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.
Measured: 2017-2023
The differences in chlorpromazine equivalent dose values in PwID prescribed multiple anti-psychotic treatment, with mental health indications, compared to those with no mental health indications between 2017 and 2023.
Main objective: 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?
Measured: 2017-2023
The differences in chlorpromazine equivalent dose values in PwID prescribed multiple anti-psychotic treatment before, during and after the COVID-19 pandemic.
Main objective: 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?
Measured: 2017-2023
SPC will be used to compare trends in multiple APT prescribing within/across participating healthcare trusts and utilised to track yearly oral/depots anti-psychotic treatment prescribing and monitor variation between services & patient groups.
Main objective: Can the 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)?
Measured: 2017-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start19 Dec 2023
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Rohit Shankar, University of Plymouth
- Investigators
- Professor Shankar, Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238089
- Sponsor's protocol ID
- 4548
- Other IDs
- TRUST/VC/AC/SG/6328-9580, 331470
- Acronym
- APHID
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35249557Howkins 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.
PubMed 35431024Tromans 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.
PubMed 33118913Naqvi 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.
PubMed 34865678Leucht 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.
PubMed 27460622Patel 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.
PubMed 23845387Shankar 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.
PubMed 31192534Mehta 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.
PubMed 40416595
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Way to Understand and Communicate the Burden of Antipsychotic Prescribing for Adults Across Specialist Intellectual Disability Services in England and Wales.
- ClinicalTrials.gov ID
- NCT06238089
- Acronym / sponsor ID
- APHID / 4548
- Conditions
- Intellectual Disability
- Keywords
- Intellectual Disability, Learning Disability, Anti-psychotic treatments, Over-prescribing, Psychotropic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this observational study is to establish the anti-psychotic prescribing patterns across specialist intellectual disability (ID) services in England and Wales by collecting cross-sectional retrospective data at 7 annual time-points (1st July) from 2017 to 2023.
Detailed description
Feasibility protocol objectives:
- Is it feasible to identify People with Intellectual Disabilities (PwID) who have been prescribed 2 or more anti-psychotic medications over 7 years retrospectively.
- 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.
- 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:
- 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?
- 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?
- 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?
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Intellectual Disabilities under the care of ID services in receipt of >2 oral and/or long-acting IM injectable anti-psychotic treatments (depots).
Key inclusion criteria (4 listed)
- Patient had psychiatric review by specialist adult ID services in the last year (e.g. for a patient to be included at 1st June 2017, data to be recorded from the most recent psychiatric review within the period between 1st January 2017 - 31st December 2017).
- 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))
Key exclusion criteria (2 listed)
- Patients treated with Clozapine
- Under the age of 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The differences in chlorpromazine equivalent dose values in PwID prescribed multiple anti-psychotic treatment across the 7-annual timepoints and across the 8 sites.
Time frame: 2017-2023
Main objective: 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.
The differences in chlorpromazine equivalent dose values in PwID prescribed multiple anti-psychotic treatment, with mental health indications, compared to those with no mental health indications between 2017 and 2023.
Time frame: 2017-2023
Main objective: 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?
The differences in chlorpromazine equivalent dose values in PwID prescribed multiple anti-psychotic treatment before, during and after the COVID-19 pandemic.
Time frame: 2017-2023
Main objective: 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?
SPC will be used to compare trends in multiple APT prescribing within/across participating healthcare trusts and utilised to track yearly oral/depots anti-psychotic treatment prescribing and monitor variation between services & patient groups.
Time frame: 2017-2023
Main objective: Can the 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)?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Background: PubMed 35249557Branford 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.
- Background: PubMed 35431024Howkins 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.
- Background: PubMed 33118913Tromans 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.
- Background: PubMed 34865678Naqvi 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.
- Background: PubMed 27460622Leucht 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.
- Background: PubMed 23845387Patel 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.
- Background: PubMed 31192534Shankar 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.
- BackgroundMehta H, Glover G. Psychotropic drugs and people with learning disabilities or autism, 2019. Public Health England.
- BackgroundNational 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).
- BackgroundTaylor DM, Barnes TR and Young AH. The Maudsley prescribing guidelines in psychiatry. 13th ed. West Sussex: Wiley-Blackwell; 2018.
- BackgroundNational Health Service. Statistical process control tool. https://www.england.nhs.uk/statisticalprocess-control-tool/ [Accessed 15th December 2023].
- Derived from this study: PubMed 40416595Stanyard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Shankar principal investigator
University of Plymouth
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disability, run by University of Plymouth at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Professor Shankar (+44 (0) 1752 439831, rohit.shankar@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differences in chlorpromazine equivalent dose values in PwID prescribed multiple anti-psychotic treatment across the 7-annual timepoints and across the 8 sites. (time frame: 2017-2023). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06238089, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.