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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
253
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.
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.
University College London
London, UK, United Kingdom
Social Functioning Scale (Assessing change over time)
Evaluates how the patient functions in daily living and social skills
Time frame: Baseline, 6 months, 12 months, 24 months
Severe relapse
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)
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.
Time frame: 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.
Time frame: Baseline, 6 months, 12 months, 24 months
Manchester Short Assessment of Quality of Life (MANSA) Assessing change over time
Assessment of quality of life.
Time frame: Baseline, 6 months, 12 months, 24 months
Digit Span (forwards and backwards) Assessing change over time
Neuropsychological assessment of short-term memory and attention
Time frame: Baseline,12 months, 24 months
Digit Symbol Coding (Assessing change over time)
A neuropsychological assessment of motor skill and attention
Time frame: Baseline,12 months, 24 months
Rey Auditory Verbal Learning (Assessing change over time)
Neuropsychological assessment of short-term memory and learning
Time frame: Baseline,12 months, 24 months
Trail Making Test (Assessing change over time)
Neuropsychological assessment of motor skills
Time frame: Baseline,12 months, 24 months
Verbal Fluency (Assessing change over time)
Neuropsychological assessment of language and communication skills
Time frame: Baseline,12 months, 24 months
Demographic Information
Demographic data about the participant
Time frame: 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)
Time frame: Baseline, 12 months, 24 months
Schedule for Economic Data from Patient Records
Health information from patient notes to inform economic analysis
Time frame: Baseline, 12 months, 24 months
Questionnaire about the Process of Recovery (QPR) Assessing change over time
Evaluates how participants view their recovery
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: Baseline, 6 months, 12 months, 24 months
Client Satisfaction Questionnaire (CSQ 8) Assessing change over time
Patient satisfaction with mental health services.
Time frame: Baseline, 6 months, 12 months, 24 months
EQ-5D-5L (Euroqol five levels- Assessing change over time)
Measure of health status
Time frame: Baseline, 6 months, 12 months, 24 months
ICECAP-A (ICEpop CAPability measure for Adults) Assessing change over time
Measure of quality of life
Time frame: Baseline, 6 months, 12 months, 24 months
Arizona Sexual Experiences Scale (ASEX) Assessing change over time
Evaluates sexual functioning
Time frame: Baseline, 6 months, 12 months, 24 months
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