SchizophreniaPhase 4NCT03559426
Research Into Antipsychotic Discontinuation and Reduction Trial
A Phase 4 study testing Antipsychotic Reduction and Antipsychotic Maintenance in people with Schizophrenia and Schizoaffective Disorder, run by University College, London at 1 site in United Kingdom.
Trial summary
Psychosis and schizophrenia are common and costly mental health problems. Psychosis is the name given to a group of mental conditions in which cause people to perceive or interpret things differently from those around them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Delusional Disorder
- What is being tested?
- Antipsychotic Reduction and Antipsychotic Maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Mar 2016to 10 Mar 2022
- Phase
- Phase 4
- 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
Who may be able to join
- Aged over 18 years
- A clinical and/or ICD10 diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or other non-affective psychosis
- More than one previous episode of relapse or psychotic exacerbation, or a single episode lasting more than one year
- Taking antipsychotic medication
Who cannot join
- Participant lacks capacity to consent to the trial
- Participant has insufficient command of spoken English to understand trial procedures
- Participant subject to section 37/41 of the Mental Health Act (MHA) or a Community Treatment Order (CTO) that includes a requirement to take antipsychotic medication.
- Clinician considers there will be a serious risk of harm to self or others
- Participant has been admitted to hospital or had treatment from the Home Treatment or Crisis Team within the last month
- Females who have a confirmed pregnancy
Show all 9Show fewer
- Females who are breast-feeding
- Involvement in another "investigational medicinal product" (IMP) trial
- No contraindications to continuing on antipsychotic medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research Into Antipsychotic Discontinuation and Reduction (RADAR): A Randomised Controlled Trial
Psychosis and schizophrenia are common and costly mental health problems. Psychosis is the name given to a group of mental conditions in which cause people to perceive or interpret things differently from those around them. One of the most common causes of psychosis is schizophrenia, a condition that causes a range of psychological symptoms, including hallucinations (hearing and/or seeing things) and delusions (believing something that is not true). One of the main treatment options for psychosis and schizophrenia is long-term treatment with antipsychotic medication, but many patients still find life difficult. Antipsychotic drugs can also have dangerous and unpleasant side effects. Finding alternatives to long-term drug treatment is a priority for patients and services. This study is testing the effects of gradually reducing antipsychotic medication in people with schizophrenia, psychosis or similar conditions in order to see if it can help improve day-to-day functioning and how it affects their chance of suffering a relapse (worsening of their condition).
Read the detailed description
The RADAR trial is a randomised controlled trial that will compare a flexible and gradual strategy of antipsychotic reduction and possible discontinuation with maintenance antipsychotic treatment in people with schizophrenia or who have recurrent psychotic episodes. In the reduction group, a guideline reduction schedule will be devised by the research team for each participant taking into account starting dose and number of antipsychotics prescribed. This may be adjusted by treating clinicians in discussion with participants. Antipsychotics will be discontinued in cases where reduction progresses well. The reduction schedule will be flexible, and will include guidance on monitoring and treating symptoms and signs of early relapse.
Participants will be individually randomised to the two treatment strategies, which will be administered by treating clinicians. They will be followed up for two years. The primary outcome is social functioning, and secondary outcomes include relapse, symptoms, side effects, employment and medication adherence.
- Being tested
- Antipsychotic Reduction, Antipsychotic Maintenance
- Keywords
- antipsychotics, schizophrenia, reduction
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia, Paranoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antipsychotic ReductionDrug
Antipsychotic medication is gradually reduced and discontinued if possible. A flexible individualised antipsychotic reduction schedule is devised for each patient by the research team, based on the participant's initial antipsychotic regime. Antipsychotic dose is reduced incrementally every two months, with flexibility to speed up or slow down the schedule in discussion with the patient. The antipsychotic reduction extends over a period of between six to 12 months, although this may be extended according to individual circumstances.
Antipsychotic MaintenanceDrug
Participants continue to receive antipsychotic treatment at the original dose for the 24 month duration of the trial. Increases or minor adjustments to antipsychotic medication are permitted.
| Study group | Role | What they receive |
|---|---|---|
| Antipsychotic Maintenance | Active comparator | Participants continue to receive antipsychotic treatment at the original dose for the 24 month duration of the trial. Increases or minor adjustments to antipsychotic medication are permitted. Receives: Drug: Antipsychotic Maintenance |
| Antipsychotic Reduction | Experimental | Antipsychotic medication is gradually reduced and discontinued if possible. A flexible individualised antipsychotic reduction schedule is devised for each patient by the research team, based on the participant's initial antipsychotic regime. Antipsychotic dose is reduced incrementally every two months, with flexibility to speed up or slow down the schedule in discussion with the patient. The antipsychotic reduction extends over a period of between six to 12 months, although this may be extended according to individual circumstances. Receives: Drug: Antipsychotic Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Functioning Scale (Assessing change over time)
Evaluates how the patient functions in daily living and social skills
Measured: Baseline, 6 months, 12 months, 24 months
Secondary outcomes (20)
Severe relapse
Severe relapse is defined as admission to hospital for a relapse of a psychotic condition.
Measured: Duration of the trial follow-up (24 months)
Positive and Negative Syndrome Scale (PANSS) Assessing change over time
Clinical assessment of current symptomology. Measure refers to prevalence of psychotic symptoms ranging from absent to extreme.
Measured: Baseline, 6 months, 12 months, 24 months
Modified Glasgow Antipsychotics Side-Effects Scale (GASS) Assessing change over time
Self-report measure of physical and mental side effects patient has experienced recently. Scale refers to prevalence of side effects from antipsychotic medication in the last week.
Measured: Baseline, 6 months, 12 months, 24 months
Manchester Short Assessment of Quality of Life (MANSA) Assessing change over time
Assessment of quality of life.
Measured: Baseline, 6 months, 12 months, 24 months
Digit Span (forwards and backwards) Assessing change over time
Neuropsychological assessment of short-term memory and attention
Measured: Baseline,12 months, 24 months
Digit Symbol Coding (Assessing change over time)
A neuropsychological assessment of motor skill and attention
Measured: Baseline,12 months, 24 months
Rey Auditory Verbal Learning (Assessing change over time)
Neuropsychological assessment of short-term memory and learning
Measured: Baseline,12 months, 24 months
Trail Making Test (Assessing change over time)
Neuropsychological assessment of motor skills
Measured: Baseline,12 months, 24 months
Verbal Fluency (Assessing change over time)
Neuropsychological assessment of language and communication skills
Measured: Baseline,12 months, 24 months
Demographic Information
Demographic data about the participant
Measured: Baseline
Client Service Receipt Inventory (CSRI) Assessing change over time
Economic measure of health service use including frequency services are used (inc. mental health, physical health, criminal justice, council activities) and medication currently used (inc. measuring dosage, frequency, medication name, and how long its been taken for)
Measured: Baseline, 12 months, 24 months
Schedule for Economic Data from Patient Records
Health information from patient notes to inform economic analysis
Measured: Baseline, 12 months, 24 months
Questionnaire about the Process of Recovery (QPR) Assessing change over time
Evaluates how participants view their recovery
Measured: Baseline, 6 months, 12 months, 24 months
Work Productivity and Activity Questionnaire (WPAI) Assessing change over time
Measure of the effect of health problems on occupational functioning (i.e. ability to work and perform normal daily activities)
Measured: Baseline, 6 months, 12 months, 24 months
Relapse Questionnaire (Assessing change over time)
Self-report measure of any recent experience of what the patient or their close ones would describe as a relapse (severe or non-severe). Developed for this trial to identify instances of severe and non-severe relapse.
Measured: 6 months, 12 months, 24 months
Medication Adherence Rating Scale (MARS-5) Assessing change over time
Self-report measure of how participant is currently using antipsychotic medication (medication adherence)
Measured: Baseline, 6 months, 12 months, 24 months
Client Satisfaction Questionnaire (CSQ 8) Assessing change over time
Patient satisfaction with mental health services.
Measured: Baseline, 6 months, 12 months, 24 months
EQ-5D-5L (Euroqol five levels- Assessing change over time)
Measure of health status
Measured: Baseline, 6 months, 12 months, 24 months
ICECAP-A (ICEpop CAPability measure for Adults) Assessing change over time
Measure of quality of life
Measured: Baseline, 6 months, 12 months, 24 months
Arizona Sexual Experiences Scale (ASEX) Assessing change over time
Evaluates sexual functioning
Measured: Baseline, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start24 Mar 2016
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open, parallel group, multi-centre randomised controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna Moncrieff, MBBS, Principal investigator, NHS / UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559426
- Sponsor's protocol ID
- 15/0947
- Status last verified
- May 2022
- First submitted
- 29 May 2018
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moncrieff J, Crellin N, Stansfeld J, Cooper R, Marston L, Freemantle N, Lewis G, Hunter R, Johnson S, Barnes T, Morant N, Pinfold V, Smith R, Kent L, Darton K, Long M, Horowitz M, Horne R, Vickerstaff V, Jha M, Priebe S. Antipsychotic dose reduction and discontinuation versus maintenance treatment in people with schizophrenia and other recurrent psychotic disorders in England (the RADAR trial): an open, parallel-group, randomised controlled trial. Lancet Psychiatry. 2023 Nov;10(11):848-859. doi: 10.1016/S2215-0366(23)00258-4. Epub 2023 Sep 28.
PubMed 37778356
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Into Antipsychotic Discontinuation and Reduction (RADAR): A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03559426
- Acronym / sponsor ID
- 15/0947
- Keywords
- antipsychotics, schizophrenia, reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 18 Jun 2018 (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.
Psychosis and schizophrenia are common and costly mental health problems. Psychosis is the name given to a group of mental conditions in which cause people to perceive or interpret things differently from those around them. One of the most common causes of psychosis is schizophrenia, a condition that causes a range of psychological symptoms, including hallucinations (hearing and/or seeing things) and delusions (believing something that is not true). One of the main treatment options for psychosis and schizophrenia is long-term treatment with antipsychotic medication, but many patients still find life difficult. Antipsychotic drugs can also have dangerous and unpleasant side effects. Finding alternatives to long-term drug treatment is a priority for patients and services. This study is testing the effects of gradually reducing antipsychotic medication in people with schizophrenia, psychosis or similar conditions in order to see if it can help improve day-to-day functioning and how it affects their chance of suffering a relapse (worsening of their condition).
Detailed description
The RADAR trial is a randomised controlled trial that will compare a flexible and gradual strategy of antipsychotic reduction and possible discontinuation with maintenance antipsychotic treatment in people with schizophrenia or who have recurrent psychotic episodes. In the reduction group, a guideline reduction schedule will be devised by the research team for each participant taking into account starting dose and number of antipsychotics prescribed. This may be adjusted by treating clinicians in discussion with participants. Antipsychotics will be discontinued in cases where reduction progresses well. The reduction schedule will be flexible, and will include guidance on monitoring and treating symptoms and signs of early relapse.
Participants will be individually randomised to the two treatment strategies, which will be administered by treating clinicians. They will be followed up for two years. The primary outcome is social functioning, and secondary outcomes include relapse, symptoms, side effects, employment and medication adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Open, parallel group, multi-centre randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Antipsychotic Maintenance | Active comparator | Drug: Antipsychotic MaintenanceParticipants continue to receive antipsychotic treatment at the original dose for the 24 month duration of the trial. Increases or minor adjustments to antipsychotic medication are permitted. |
| Antipsychotic Reduction | Experimental | Drug: Antipsychotic ReductionAntipsychotic medication is gradually reduced and discontinued if possible. A flexible individualised antipsychotic reduction schedule is devised for each patient by the research team, based on the participant's initial antipsychotic regime. Antipsychotic dose is reduced incrementally every two months, with flexibility to speed up or slow down the schedule in discussion with the patient. The antipsychotic reduction extends over a period of between six to 12 months, although this may be extended according to individual circumstances. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged over 18 years
- A clinical and/or ICD10 diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or other non-affective psychosis
- More than one previous episode of relapse or psychotic exacerbation, or a single episode lasting more than one year
- Taking antipsychotic medication
Key exclusion criteria (9 listed)
- Participant lacks capacity to consent to the trial
- Participant has insufficient command of spoken English to understand trial procedures
- Participant subject to section 37/41 of the Mental Health Act (MHA) or a Community Treatment Order (CTO) that includes a requirement to take antipsychotic medication.
- Clinician considers there will be a serious risk of harm to self or others
- Participant has been admitted to hospital or had treatment from the Home Treatment or Crisis Team within the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antipsychotic ReductionAntipsychotic medication is gradually reduced and discontinued if possible. A flexible individualised antipsychotic reduction schedule is devised for each patient by the research team, based on the participant's initial antipsychotic regime. Antipsychotic dose is reduced incrementally every two months, with flexibility to speed up or slow down the schedule in discussion with the patient. The antipsychotic reduction extends over a period of between six to 12 months, although this may be extended according to individual circumstances. | Drug | Antipsychotic Reduction |
| Antipsychotic MaintenanceParticipants continue to receive antipsychotic treatment at the original dose for the 24 month duration of the trial. Increases or minor adjustments to antipsychotic medication are permitted. | Drug | Antipsychotic Maintenance |
Primary outcome
Social Functioning Scale (Assessing change over time)
Time frame: Baseline, 6 months, 12 months, 24 months
Evaluates how the patient functions in daily living and social skills
20 secondary outcomes
Severe relapse
Time frame: Duration of the trial follow-up (24 months)
Positive and Negative Syndrome Scale (PANSS) Assessing change over time
Time frame: Baseline, 6 months, 12 months, 24 months
Modified Glasgow Antipsychotics Side-Effects Scale (GASS) Assessing change over time
Time frame: Baseline, 6 months, 12 months, 24 months
Manchester Short Assessment of Quality of Life (MANSA) Assessing change over time
Time frame: Baseline, 6 months, 12 months, 24 months
Digit Span (forwards and backwards) Assessing change over time
Time frame: Baseline,12 months, 24 months
Digit Symbol Coding (Assessing change over time)
Time frame: Baseline,12 months, 24 months
Rey Auditory Verbal Learning (Assessing change over time)
Time frame: Baseline,12 months, 24 months
Trail Making Test (Assessing change over time)
Time frame: Baseline,12 months, 24 months
Verbal Fluency (Assessing change over time)
Time frame: Baseline,12 months, 24 months
Demographic Information
Time frame: Baseline
Client Service Receipt Inventory (CSRI) Assessing change over time
Time frame: Baseline, 12 months, 24 months
Schedule for Economic Data from Patient Records
Time frame: Baseline, 12 months, 24 months
Questionnaire about the Process of Recovery (QPR) Assessing change over time
Time frame: Baseline, 6 months, 12 months, 24 months
Work Productivity and Activity Questionnaire (WPAI) Assessing change over time
Time frame: Baseline, 6 months, 12 months, 24 months
Relapse Questionnaire (Assessing change over time)
Time frame: 6 months, 12 months, 24 months
Medication Adherence Rating Scale (MARS-5) Assessing change over time
Time frame: Baseline, 6 months, 12 months, 24 months
Client Satisfaction Questionnaire (CSQ 8) Assessing change over time
Time frame: Baseline, 6 months, 12 months, 24 months
EQ-5D-5L (Euroqol five levels- Assessing change over time)
Time frame: Baseline, 6 months, 12 months, 24 months
ICECAP-A (ICEpop CAPability measure for Adults) Assessing change over time
Time frame: Baseline, 6 months, 12 months, 24 months
Arizona Sexual Experiences Scale (ASEX) Assessing change over time
Time frame: Baseline, 6 months, 12 months, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 37778356Moncrieff J, Crellin N, Stansfeld J, Cooper R, Marston L, Freemantle N, Lewis G, Hunter R, Johnson S, Barnes T, Morant N, Pinfold V, Smith R, Kent L, Darton K, Long M, Horowitz M, Horne R, Vickerstaff V, Jha M, Priebe S. Antipsychotic dose reduction and discontinuation versus maintenance treatment in people with schizophrenia and other recurrent psychotic disorders in England (the RADAR trial): an open, parallel-group, randomised controlled trial. Lancet Psychiatry. 2023 Nov;10(11):848-859. doi: 10.1016/S2215-0366(23)00258-4. Epub 2023 Sep 28.
- RADAR websiteLink provided by the sponsor.
- 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.
Joanna Moncrieff, MBBS principal investigator
NHS / UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antipsychotic Reduction and Antipsychotic Maintenance in people with Schizophrenia and Schizoaffective Disorder, run by University College, London at 1 site 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 9 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: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Functioning Scale (Assessing change over time) (time frame: Baseline, 6 months, 12 months, 24 months). 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 NCT03559426, which also lists 1 linked publication.
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 23 May 2022.