Clinical trial NCT03559426: Research Into Antipsychotic Discontinuation and Reduction Trial
Official title: Research Into Antipsychotic Discontinuation and Reduction (RADAR): A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Delusional Disorder
Schizophreniform Disorders
Keywords: antipsychotics
schizophrenia
reduction
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open, parallel group, multi-centre randomised controlled trial.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Social Functioning Scale (Assessing change over time)
timeFrame: Baseline, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Severe relapse
timeFrame: Duration of the trial follow-up (24 months)
measure: Positive and Negative Syndrome Scale (PANSS) Assessing change over time
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Modified Glasgow Antipsychotics Side-Effects Scale (GASS) Assessing change over time
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Manchester Short Assessment of Quality of Life (MANSA) Assessing change over time
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Digit Span (forwards and backwards) Assessing change over time
timeFrame: Baseline,12 months, 24 months
measure: Digit Symbol Coding (Assessing change over time)
timeFrame: Baseline,12 months, 24 months
measure: Rey Auditory Verbal Learning (Assessing change over time)
timeFrame: Baseline,12 months, 24 months
measure: Trail Making Test (Assessing change over time)
timeFrame: Baseline,12 months, 24 months
measure: Verbal Fluency (Assessing change over time)
timeFrame: Baseline,12 months, 24 months
measure: Demographic Information
timeFrame: Baseline
measure: Client Service Receipt Inventory (CSRI) Assessing change over time
timeFrame: Baseline, 12 months, 24 months
measure: Schedule for Economic Data from Patient Records
timeFrame: Baseline, 12 months, 24 months
measure: Questionnaire about the Process of Recovery (QPR) Assessing change over time
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Work Productivity and Activity Questionnaire (WPAI) Assessing change over time
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Relapse Questionnaire (Assessing change over time)
timeFrame: 6 months, 12 months, 24 months
measure: Medication Adherence Rating Scale (MARS-5) Assessing change over time
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Client Satisfaction Questionnaire (CSQ 8) Assessing change over time
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: EQ-5D-5L (Euroqol five levels- Assessing change over time)
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: ICECAP-A (ICEpop CAPability measure for Adults) Assessing change over time
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Arizona Sexual Experiences Scale (ASEX) Assessing change over time
timeFrame: Baseline, 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
state: UK
Study officials:
affiliation: NHS / UCL
name: Joanna Moncrieff, MBBS
role: PRINCIPAL_INVESTIGATOR
References: