2024-518042-24-00招募中4 期
An open label signal detection study to evaluate the effects of cariprazine on cognitive functioning in patients with schizophrenia in need of adjustment of oral antipsychotic treatment
Medizinische Universitaet Innsbruck2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月29日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To investigate changes in the BACS and HFERST scores and in fMRI data from baseline to week 28
研究概览
简要总结
The primary objective is to assess changes in cognitive functioning in schizophrenia patients starting treatment with cariprazine
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia as defined by ICD-10 as determined by the M.I.N.I.
- •Age 18-65 years
- •Without hospitalization due to worsening of psychosis and without any modification in psychopharmacological treatment for at least 8 weeks
- •In need of adjustment of the current oral antipsychotic treatment as judged by the treating psychiatrist
- •CGI-S baseline score ≥ 4
- •Capable of providing written informed consent
排除标准
- •A score of ≥ 5 on the PANSS items related to delusions (P1), conceptual disorganization (P2), and hallucinatory behavior (P3)
- •Patients who participated in another trial with an investigational drug or cognitive-enhancing intervention within 90 days prior to screening
- •Patients who are not fluent in the language of the cognitive batteries and questionnaires
- •Pregnancy or breast-feeding
- •Regularly taking centrally active medications except antipsychotics (mood stabilizers, antidepressants, etc.)
- •Patients with contraindications to MRI (e.g. claustrophobia, pacemaker, non-MRI-compatible implants)
- •Presence of predominant negative symptoms (PANSS FSNS >24 and PANSS FSPS <19) to avoid pseudospecificity
- •Presence of clinically significant extrapyramidal symptoms, defined a score of ≥ 3 on one of the subscales of the St. Hans Rating Scale (global hyperkinesia subscale, global parkinsonism subscale, dystonia subscale, akathisia subscale) and/or the use of anticholinergics for the treatment of extrapyramidal motor symptoms
- •Presence of clinically significant symptoms of depression, defined as a total score of ≥ 11 on the CDSS
- •Active suicidal ideation as measured through the C-SSRS, defined as an answer of ‘Yes’ to items 4 and/or 5
- •A diagnosis of alcohol and/or drug abuse or dependence as assessed through the M.I.N.I. or a positive UDS
- •IQ of 70 or less as assessed through the MWT-B
- •Patients who are currently treated with cariprazine or have shown insufficient response or intolerance to cariprazine in the past
- •Current treatment with clozapine
结局指标
主要结局
To investigate changes in the BACS and HFERST scores and in fMRI data from baseline to week 28
To investigate changes in the BACS and HFERST scores and in fMRI data from baseline to week 28
次要结局
- Longitudinal changes in the following measures: 1. PANSS 2. NSA-4 3. CGI 4. CDRS 5. SHRS/SMARTS 6. MARS 7. PSP 8. EQ-5D
研究者
University Hospital for Psychiatry I
Scientific
Medizinische Universitaet Innsbruck
研究点 (2)
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