Research Into Antipsychotic Discontinuation and Reduction (RADAR): A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Social Functioning Scale (Assessing change over time)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Antipsychotic Maintenance (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.
干预措施: Antipsychotic Reduction (Drug)
结局指标
主要结局
Social Functioning Scale (Assessing change over time)
时间窗: Baseline, 6 months, 12 months, 24 months
Evaluates how the patient functions in daily living and social skills
次要结局
- 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)
- Trail Making Test (Assessing change over time)(Baseline,12 months, 24 months)
- Verbal Fluency (Assessing change over time)(Baseline,12 months, 24 months)
- Digit Span (forwards and backwards) Assessing change over time(Baseline,12 months, 24 months)
- Digit Symbol Coding (Assessing change over time)(Baseline,12 months, 24 months)
- Demographic Information(Baseline)
- Client Service Receipt Inventory (CSRI) Assessing change over time(Baseline, 12 months, 24 months)
- Rey Auditory Verbal Learning (Assessing change over time)(Baseline,12 months, 24 months)
- Schedule for Economic Data from Patient Records(Baseline, 12 months, 24 months)
- Questionnaire about the Process of Recovery (QPR) Assessing change over time(Baseline, 6 months, 12 months, 24 months)
- Work Productivity and Activity Questionnaire (WPAI) Assessing change over time(Baseline, 6 months, 12 months, 24 months)
- Relapse Questionnaire (Assessing change over time)(6 months, 12 months, 24 months)
- Medication Adherence Rating Scale (MARS-5) Assessing change over time(Baseline, 6 months, 12 months, 24 months)
- Client Satisfaction Questionnaire (CSQ 8) Assessing change over time(Baseline, 6 months, 12 months, 24 months)
- EQ-5D-5L (Euroqol five levels- Assessing change over time)(Baseline, 6 months, 12 months, 24 months)
- ICECAP-A (ICEpop CAPability measure for Adults) Assessing change over time(Baseline, 6 months, 12 months, 24 months)
- Arizona Sexual Experiences Scale (ASEX) Assessing change over time(Baseline, 6 months, 12 months, 24 months)