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Research Into Antipsychotic Discontinuation and Reduction Trial

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Delusional Disorder

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Antipsychotic Reduction
Antipsychotic Maintenance
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring antipsychotics, schizophrenia, reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Females who are breast-feeding
  • Involvement in another "investigational medicinal product" (IMP) trial
  • No contraindications to continuing on antipsychotic medication

Sites / Locations

  • University College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Antipsychotic Maintenance

Antipsychotic Reduction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Social Functioning Scale (Assessing change over time)
Evaluates how the patient functions in daily living and social skills

Secondary Outcome Measures

Severe relapse
Severe relapse is defined as admission to hospital for a relapse of a psychotic condition.
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.
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.
Manchester Short Assessment of Quality of Life (MANSA) Assessing change over time
Assessment of quality of life.
Digit Span (forwards and backwards) Assessing change over time
Neuropsychological assessment of short-term memory and attention
Digit Symbol Coding (Assessing change over time)
A neuropsychological assessment of motor skill and attention
Rey Auditory Verbal Learning (Assessing change over time)
Neuropsychological assessment of short-term memory and learning
Trail Making Test (Assessing change over time)
Neuropsychological assessment of motor skills
Verbal Fluency (Assessing change over time)
Neuropsychological assessment of language and communication skills
Demographic Information
Demographic data about the participant
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)
Schedule for Economic Data from Patient Records
Health information from patient notes to inform economic analysis
Questionnaire about the Process of Recovery (QPR) Assessing change over time
Evaluates how participants view their recovery
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)
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.
Medication Adherence Rating Scale (MARS-5) Assessing change over time
Self-report measure of how participant is currently using antipsychotic medication (medication adherence)
Client Satisfaction Questionnaire (CSQ 8) Assessing change over time
Patient satisfaction with mental health services.
EQ-5D-5L (Euroqol five levels- Assessing change over time)
Measure of health status
ICECAP-A (ICEpop CAPability measure for Adults) Assessing change over time
Measure of quality of life
Arizona Sexual Experiences Scale (ASEX) Assessing change over time
Evaluates sexual functioning

Full Information

First Posted
May 29, 2018
Last Updated
May 20, 2022
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT03559426
Brief Title
Research Into Antipsychotic Discontinuation and Reduction Trial
Official Title
Research Into Antipsychotic Discontinuation and Reduction (RADAR): A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2016 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
March 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Delusional Disorder, Schizophreniform Disorders
Keywords
antipsychotics, schizophrenia, reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Open, parallel group, multi-centre randomised controlled trial.
Masking
Outcomes Assessor
Masking Description
Participants and treating clinicians will not be blinded because participants will start on different antipsychotic regimes, and those within the antipsychotic reduction intervention will follow an individualised reduction protocol. Following trial extension the sample size was reduced from 402 to 218. The study is now powered to the primary outcome 'social functioning'. Members of the research team conducting outcome assessments will be blinded to treatment allocation.
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antipsychotic Maintenance
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Antipsychotic Reduction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Antipsychotic Reduction
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Antipsychotic Maintenance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Functioning Scale (Assessing change over time)
Description
Evaluates how the patient functions in daily living and social skills
Time Frame
Baseline, 6 months, 12 months, 24 months
Secondary Outcome Measure Information:
Title
Severe relapse
Description
Severe relapse is defined as admission to hospital for a relapse of a psychotic condition.
Time Frame
Duration of the trial follow-up (24 months)
Title
Positive and Negative Syndrome Scale (PANSS) Assessing change over time
Description
Clinical assessment of current symptomology. Measure refers to prevalence of psychotic symptoms ranging from absent to extreme.
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Modified Glasgow Antipsychotics Side-Effects Scale (GASS) Assessing change over time
Description
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.
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Manchester Short Assessment of Quality of Life (MANSA) Assessing change over time
Description
Assessment of quality of life.
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Digit Span (forwards and backwards) Assessing change over time
Description
Neuropsychological assessment of short-term memory and attention
Time Frame
Baseline,12 months, 24 months
Title
Digit Symbol Coding (Assessing change over time)
Description
A neuropsychological assessment of motor skill and attention
Time Frame
Baseline,12 months, 24 months
Title
Rey Auditory Verbal Learning (Assessing change over time)
Description
Neuropsychological assessment of short-term memory and learning
Time Frame
Baseline,12 months, 24 months
Title
Trail Making Test (Assessing change over time)
Description
Neuropsychological assessment of motor skills
Time Frame
Baseline,12 months, 24 months
Title
Verbal Fluency (Assessing change over time)
Description
Neuropsychological assessment of language and communication skills
Time Frame
Baseline,12 months, 24 months
Title
Demographic Information
Description
Demographic data about the participant
Time Frame
Baseline
Title
Client Service Receipt Inventory (CSRI) Assessing change over time
Description
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)
Time Frame
Baseline, 12 months, 24 months
Title
Schedule for Economic Data from Patient Records
Description
Health information from patient notes to inform economic analysis
Time Frame
Baseline, 12 months, 24 months
Title
Questionnaire about the Process of Recovery (QPR) Assessing change over time
Description
Evaluates how participants view their recovery
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Work Productivity and Activity Questionnaire (WPAI) Assessing change over time
Description
Measure of the effect of health problems on occupational functioning (i.e. ability to work and perform normal daily activities)
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Relapse Questionnaire (Assessing change over time)
Description
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.
Time Frame
6 months, 12 months, 24 months
Title
Medication Adherence Rating Scale (MARS-5) Assessing change over time
Description
Self-report measure of how participant is currently using antipsychotic medication (medication adherence)
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Client Satisfaction Questionnaire (CSQ 8) Assessing change over time
Description
Patient satisfaction with mental health services.
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
EQ-5D-5L (Euroqol five levels- Assessing change over time)
Description
Measure of health status
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
ICECAP-A (ICEpop CAPability measure for Adults) Assessing change over time
Description
Measure of quality of life
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Arizona Sexual Experiences Scale (ASEX) Assessing change over time
Description
Evaluates sexual functioning
Time Frame
Baseline, 6 months, 12 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Females who are breast-feeding Involvement in another "investigational medicinal product" (IMP) trial No contraindications to continuing on antipsychotic medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Moncrieff, MBBS
Organizational Affiliation
NHS / UCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London
City
London
State/Province
UK
ZIP/Postal Code
W1T 7BN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.ucl.ac.uk/psychiatry/antipsychotic-discontinuation-and-reduction
Description
RADAR website

Learn more about this trial

Research Into Antipsychotic Discontinuation and Reduction Trial

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