A Randomized, Multicenter Clinical Trial to Assess the Efficacy and Safety of Clozapine vs Treatment as Usual for Treatment-resistant Psychosis in Adolescents and Young Adults With Intellectual Disability.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 20
- 主要终点
- Clinical improvement based on Clinical Global Impression-Schizophrenia (CGI-SCH) scale score.
研究概览
简要总结
This clinical trial will prove whether a large number of people with intellectual disability and treatment-resistant psychosis could benefit from the use of clozapine. Benefit will mean a measurable significant improvement in subjects' clinical response and quality of life.
详细描述
Randomized, open-label, multicenter phase II clinical trial that seeks to evaluate the safety and efficacy of clozapine versus standard clinical treatment in patients between the ages of 16 and 55 with intellectual disability and treatment-resistant psychosis.
Clozapine is the most effective antipsychotic for patients with non-affective psychosis who do not respond to other first and second generation antipsychotic treatments. In addition, it has been shown to be very effective in another series of clinical situations such as hostility and aggressiveness, polydipsia and in behavioral disorders and psychosis, frequent situations in people with intellectual disabilities.
The primary objective is to assess the efficacy and safety of clozapine versus standard clinical practice treatment in patients with intellectual disability and resistant psychotic disorder, as measured by change in Clinical Global Impression: Clinical Global Impression-Schizophrenia scale (ICG-SCH) global score over trial visits.
The study determines to reach a sample size of 114 patients distributed among the 25 active centers. Randomization is 1:1 and consists of 6 visits to the center spread over 12 months. At each visit, the patient will undergo a physical examination and sample collection, along with a clinical and cognitive evaluation using the scales provided in accordance with the clinical guidelines.
In addition, if the patient falls into the experimental arm (Clozapine), it is necessary to collect a blood sample weekly during the first 18 weeks and biweekly until completing the 12 months of the study, so that the medical team has special control in the analytical parameters.
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
- None
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 16 and 55 years
- •Diagnosis of intellectual disability according to the Diagnostic and Statistical Manual of Mental Disorders Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (confirmed by a Intelligence Quotient (IQ) Score between 35 and 70 in the Kaufman test)
- •Diagnosis of psychosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (confirmed by clinical interview).
- •Treatment Resistant to antipsychotic drugs except clozapine.
- •Behavioural disturbances and self-injurious behaviour over the last 6 months.
- •Written informed consent of patients or legal representative.
- •Negative pregnancy test (if apply)
排除标准
- •Leukocytes < 3500/mm3 and neutrophils < 2000/mm
- •Hypersensitivity to clozapine or excipients.
- •Myeloproliferative disorders
- •Uncontrolled epilepsy in the last 2 years.
- •Paralytic ileus in the last 3 months.
- •Diagnosis of an autism spectrum disorder
- •Pregnancy and breastfeeding
- •Any diseases with clozapine contraindicated.
- •Any uncontrolled serious condition
- •Need of treatment with more than one antipsychotic drug or electroconvulsive therapy
- •Treatment with quinolones, drugs that cause agranulocytosis or drugs that affect the cytochrome P-450 enzymes.
- •Risk of suicide based on the Columbia-Suicide Severity Rating Scale
研究组 & 干预措施
Clozapine
Pharmaceutical Form: Tablet Anatomical Therapeutic Chemical classification system (ATC Code): N: nervous system, N05: psycholeptic, N05A: antipsychotic, N05AH02: clozapine (N05AH02)
干预措施: Clozapine (Drug)
Control
Usual antipsychotic medication used in the treatment of treatment-resistant psychosis.
干预措施: haloperidol, pimozide, olanzapine, risperidone, amisulpride (Drug)
结局指标
主要结局
Clinical improvement based on Clinical Global Impression-Schizophrenia (CGI-SCH) scale score.
时间窗: Baseline and 12 Months
Overall Severity of Illness as measured by change from baseline to last study visit score Minimum value = 1 Normal, not ill Maximum value = 7 Among the most severely ill
次要结局
- Clinical improvement based on Positive and Negative Syndrome Scale (PANSS)(Baseline and 12 Months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Up to 28 days after the last investigational medicinal product administration)
- Quality of Life Improvement based on the 5 levels Quality of Life 5 dimensional (5D) 5 levels (5L) questionnaire (Euro-QoL 5D-5L scale)(Baseline and 12 Months)
- Clinical improvement based on Scale for the Assessment of Negative Symptoms (SANS)(Baseline and 12 Months)