2024-516768-28-00招募中4 期
Open-label, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Aripiprazole vs Paliperidone/Risperidone Using Multi-omics Data in Patients With a First Episode Psychosis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 12
- 主要终点
- Therapeutic response to aripiprazole or paliperidone
研究概览
简要总结
- To identify a set of biomarkers using multi-omics techniques to predict the therapeutic response of aripiprazole or paliperidone after 3 months of treatment in patients with a first psychotic episode of the schizophrenia spectrum
- To assess the efficacy of aripiprazole or paliperidone at 3 months in reducing psychotic symptoms by defining "responder" to treatment with the PANSS and CGI-S scales
- To assess the effectiveness of aripiprazole or paliperidone in the short term in patients with a first psychotic episode of the schizophrenia spectrum through the proportion of discontinuation of the first antipsychotic received (aripiprazole or paliperidone) in the first 3 months of treatment
- To assess the long-term effectiveness of aripiprazole or paliperidone in patients with a first psychotic episode of the schizophrenia spectrum through the time to discontinuation of the first antipsychotic received (aripiprazole or paliperidone) during the first year of treatment
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 15 and 40 years.
- •Patients who live in the area of influence of the site.
- •Patients who are experiencing their first psychotic episode.
- •Patients with diagnoses of the schizophrenia spectrum according to DSM-5 (schizophreniform disorder, schizophrenia, schizoaffective disorder, brief psychotic disorder or psychotic disorder not otherwise specified).
排除标准
- •Be on antipsychotic treatment for >6 weeks at the time of study drug randomization.
- •Patients who meet the DSM-5 criteria for substance dependence (other than tobacco or cannabis).
- •Patients who meet the DSM-5 criteria for intelectual disability.
- •Patients with a history of neurological pathology or traumatic brain injury.
- •Being pregnant.
- •Chronic treatment (>3 months) with oral or intramuscular corticosteroids or immunosuppressive treatment.
结局指标
主要结局
Therapeutic response to aripiprazole or paliperidone
Therapeutic response to aripiprazole or paliperidone
次要结局
- Change in positive psychotic symptoms at 3 and 12 months. Measured as change in PANSS positive symptom subscale score from baseline.
- Change in negative symptoms assessed with the PANSS at 3 and 12 months. Measured as change in PANSS negative symptom subscale score from baseline.
- Change in negative symptoms assessed with the SANS at 3 and 12 months. Measured as a change in the SANS scale score compared to baseline.
- Change in depressive symptoms at 3 and 12 months. Measured as change in CDS scale score from baseline.
- Change in functionality at 3 and 12 months. Measured as a change in the PSP scale score compared to baseline.
- Change in quality of life at 3 and 12 months. Measured as a change in the visual-analog scale of the EuroQoL scale with respect to baseline.
- Side effects at 3 and 12 months evaluated with the UKU scale. The total score (number of side effects) and qualitatively each side effect are assessed.
- Changes at 3 and 12 months in anthropometric measurements (weight, BMI, abdominal circumference), cardiovascular (blood pressure, heart rate) and laboratory tests (glycaemia, lipid profile, prolactin).
研究者
Projects Department
Scientific
Consorcio Centro De Investigacion Biomedica En Red
研究点 (12)
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