Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores
研究概览
简要总结
Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.
详细描述
Clinical trial to assess the efficacy of Vortioxetine, compared with treatment as usual in early schizophrenia. Propose: To investigate the effect of Vortioxetine in cognitive functioning and negative symptoms severity in early schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
Arm A: Vortioxetine+Usual antipsychotic treatment (TAU)
Drug:
First treatment phase: Vortioxetine 10 mg 1 tablet/d for 2 weeks added to Usual antipsychotic treatment, followed by Vortioxetine 20mg 1tablet/d for 22 weeks added to Usual antipsychotic treatment.
Wash-out period 2 weeks
干预措施: Vortioxetine (Drug)
Arm A: Vortioxetine+Usual antipsychotic treatment (TAU)
Drug:
First treatment phase: Vortioxetine 10 mg 1 tablet/d for 2 weeks added to Usual antipsychotic treatment, followed by Vortioxetine 20mg 1tablet/d for 22 weeks added to Usual antipsychotic treatment.
Wash-out period 2 weeks
干预措施: Usual Antipsychotic Treatment (Drug)
Arm B: Usual antipsychotic treatment (TAU)
Second treatment phase: Usual antipsychotic treatment: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician.
干预措施: Vortioxetine (Drug)
Arm B: Usual antipsychotic treatment (TAU)
Second treatment phase: Usual antipsychotic treatment: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician.
干预措施: Usual Antipsychotic Treatment (Drug)
结局指标
主要结局
To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores
时间窗: Baseline, week 24, week 26 and week 50
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 BACS App scores using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores
次要结局
- To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Negative Symptoms severity (Scale for Assessment of Negative Symptoms (SANS) and Negative Symptom Assessment-4 (NSA-4) total scores)(Baseline, week 4, week 12, week 24, week 26, week 30, week 38 and week 50)