2024-519778-38-00招募中3 期
Cognitive effects of adjuntive Vortioxetine in early Schizophrenia
Fundacion Para La Gestion De La Investigacion En Salud De Sevilla1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年12月2日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Primary outcome measures: Cognitive functioning improvement assessed by the change in BACS App scores.
研究概览
简要总结
Primary objective: To assess the effectiveness of Vortioxetine vs. TAU in the treatment of cognitive impairments in early psychosis, measured by the change From Baseline to Week 24 in Brief Assessment of Cognition in Schizophrenia (BACS App) scores using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores. [Time Frame: Baseline, week 24, week 26 and week 50]
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM - SCID) diagnosis of Schizophrenia spectrum disorders.
- •Age >18-50 years old
- •Stable antipsychotic medication doses during at least 4 weeks ( all second generation antipsychotics excluding clozapine).
- •No antidepressant treatment for at least 8 weeks prior to randomization.
- •PANSS Negative subscore >14 with at least two of the items at a level >/=4 (moderate)
- •PANSS Positive subscore </=14 with not more than one of the items at a level >/=4 (moderate)
- •Hamilton Depression Rating Scale (HAMD-17) total score </=12
- •Simpson Angus Score of any item <2
- •Behaviorally Anchored Rating Scale (BARS) of any item </= 1
- •Competent and willing to sign informed consent
- •The patient, if a woman, must: agree not to try to become pregnant during the study and use adequate, highly effective contraception
排除标准
- •Patients taking any antidepressant and its use cannot be discontinued at least 8 weeks prior to randomization.
- •Structural brain disease (based on previous medical records)
- •Cognitive disability by history and estimated intelligence quotient (IQ) <70 (ID DSM-5 diagnosis).
- •Any serious chronic medical illnesses that may interfere with the patient's ability to comply with the study procedures or that will interfere with cognition.
- •Organic mental disorders, or mental disorders due to a general medical condition. Any neurological or neurodegenerative disorders.
- •Any current diagnosis of substance abuse or dependence.
- •Serious risk of suicide.
- •Patients with thyroid conditions.
- •Intolerance to or inefficacy of vortioxetine in the past. Patients who had failed treatment with vortioxetine were also excluded.
- •Pregnant or breastfeeding female.
结局指标
主要结局
Primary outcome measures: Cognitive functioning improvement assessed by the change in BACS App scores.
Primary outcome measures: Cognitive functioning improvement assessed by the change in BACS App scores.
次要结局
未报告次要终点
研究者
UICEC-HUVR (Clinical Trial Unit)
Scientific
Fundacion Para La Gestion De La Investigacion En Salud De Sevilla
研究点 (1)
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