NCT03559426

Research Into Antipsychotic Discontinuation and Reduction Trial

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Delusional Disorder
• Schizophreniform Disorders

Interventions

Type	Name	Description
DRUG	Antipsychotic Reduction	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.
DRUG	Antipsychotic Maintenance	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.

Timeline

• Start date: 2016-03-24
• Primary completion: 2022-03-10
• Completion: 2022-03-10
• First posted: 2018-06-18
• Last updated: 2022-05-23

Locations

1 site across 1 country: United Kingdom