Research Into Antipsychotic Discontinuation and Reduction Trial

NCT03559426 | Completed Phase 4 DMC

• 1 other identifier: 15/0947
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia; Schizoaffective Disorder; Delusional Disorder; Schizophreniform Disorders

Keywords

antipsychotics; schizophrenia; reduction

Outcome Measures

Primary Outcomes (1)

• Social Functioning Scale (Assessing change over time)

  Evaluates how the patient functions in daily living and social skills

  Baseline, 6 months, 12 months, 24 months

Secondary Outcomes (20)

• Severe relapse

  Duration of the trial follow-up (24 months)

• Positive and Negative Syndrome Scale (PANSS) Assessing change over time

  Baseline, 6 months, 12 months, 24 months

• Modified Glasgow Antipsychotics Side-Effects Scale (GASS) Assessing change over time

  Baseline, 6 months, 12 months, 24 months

• Manchester Short Assessment of Quality of Life (MANSA) Assessing change over time

  Baseline, 6 months, 12 months, 24 months

• Digit Span (forwards and backwards) Assessing change over time

  Baseline,12 months, 24 months

Study Arms (2)

Antipsychotic Maintenance

ACTIVE COMPARATOR

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.

Drug: Antipsychotic Maintenance

Antipsychotic Reduction

EXPERIMENTAL

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 Reduction

Interventions

Antipsychotic Reduction 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.

Antipsychotic Reduction

Antipsychotic Maintenance 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 Maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, UK, W1T 7BN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37778356 DERIVED

Related Links

• RADAR website

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Schizophrenia, Paranoid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Joanna Moncrieff, MBBS

  NHS / UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and treating clinicians will not be blinded because participants will start on different antipsychotic regimes, and those within the antipsychotic reduction intervention will follow an individualised reduction protocol. Following trial extension the sample size was reduced from 402 to 218. The study is now powered to the primary outcome 'social functioning'. Members of the research team conducting outcome assessments will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open, parallel group, multi-centre randomised controlled trial.

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 18, 2018
• Study Start: March 24, 2016
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)