Research Into Antipsychotic Discontinuation and Reduction Trial

NCT ID: NCT03559426

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-24
• Study Completion Date: 2022-03-10

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Delusional Disorder; Schizophreniform Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Antipsychotic Maintenance

Intervention Type: DRUG

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 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.

Group Type: EXPERIMENTAL

Antipsychotic Reduction

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna Moncrieff, MBBS

Role: PRINCIPAL_INVESTIGATOR

NHS / UCL

Locations

University College London

London, UK, United Kingdom

Countries

United Kingdom

References

Moncrieff J, Crellin N, Stansfeld J, Cooper R, Marston L, Freemantle N, Lewis G, Hunter R, Johnson S, Barnes T, Morant N, Pinfold V, Smith R, Kent L, Darton K, Long M, Horowitz M, Horne R, Vickerstaff V, Jha M, Priebe S. Antipsychotic dose reduction and discontinuation versus maintenance treatment in people with schizophrenia and other recurrent psychotic disorders in England (the RADAR trial): an open, parallel-group, randomised controlled trial. Lancet Psychiatry. 2023 Nov;10(11):848-859. doi: 10.1016/S2215-0366(23)00258-4. Epub 2023 Sep 28.

Reference Type: DERIVED

PMID: 37778356 (View on PubMed)

Related Links

http://www.ucl.ac.uk/psychiatry/antipsychotic-discontinuation-and-reduction

RADAR website

Other Identifiers

15/0947

Identifier Type: -

Identifier Source: org_study_id