Research into Antipsychotic Discontinuation and Reduction (RADAR): A Randomised Controlled Trial

Study ID: 31486
Short Title: RADAR Trial
Organisation: Southern Health NHS Foundation Trust
Location: Moorgreen Hospital
Condition: Psychosis - schizophrenia
Main Specialty: Mental Health
Expected End Date: 31/07/2019
Postcode: SO30 3JB
Contact Name: R&D department
Contact Email:
Active: Yes

Inclusion Criteria

1. Aged over 18 years 2. A clinical and/or ICD10 diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or other nonaffective psychosis 3. More than one previous episode of relapse or psychotic exacerbation, or a single episode lasting more than one year 4. Taking antipsychotic medication

Exclusion Criteria

1. Participant lacks capacity to consent to the trial 2. Participant has insufficient command of spoken English to understand trial procedures 3. Participant subject to a Community Treatment Order (CTO) that includes a requirement to take antipsychotic medication 4. Clinician considers there will be a serious risk of harm to self or others 5. Participant has been admitted to hospital or had treatment from the Home Treatment or Crisis Team within the last month 6. Females who have a confirmed pregnancy 7. Females who are breast-feeding 8. Involvement in another IMP trial 9. No contraindications to continuing on antipsychotic medication

Study summary:

The RADAR trial is a randomised controlled trial that will compare a gradual strategy of antipsychotic reduction and possible discontinuation with maintenance (continuous) treatment in people with schizophrenia or who have recurrent psychotic episodes. In the reduction group, antipsychotics will be gradually reduced according to a pre-devised, individualised protocol/schedule, which will take into account starting dose and number of antipsychotics. Antipsychotics will be discontinued in some cases where reduction progresses well. The reduction schedule will be flexible and can be adjusted according to participant progress. Treating clinicians will also be given guidance on monitoring and treating symptoms and early relapse. Recruitment will occur through the Community Recovery Teams, Assertive Outreach teams, Early Intervention in Psychosis teams, Older Adults teams and Learning Disability teams within participating Trusts. 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. There will be an internal pilot trial to assess recruitment, retention and intervention adherence. The primary outcome is social functioning, and secondary outcomes include relapse, symptoms, side effects and employment. There will be an additional qualitative interview study of the experience of antipsychotic reduction conducted with participants in the antipsychotic reduction group after they have completed their final follow-up. There will also be a quantitative and qualitative evaluation of trial processes and methods.

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