NCT02013622已完成3 期
Protocol 331-13-006: An Exploratory, Multicenter, Open-label, Monotherapy, Flexible-dose Brexpiprazole (OPC 34712) Trial in Adults With Early Episode Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole monotherapy in the improvement of early-episode schizophrenia through the assessment of social functioning, efficacy, and tolerability. Early-episode schizophrenia is defined as episodes occurring ≤ 5 years after the onset of the first episode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by both the Mini International Neuropsychiatric Interview (M.I.N.I.) for Schizophrenia and Psychotic Disorders Studies and an adequate clinical psychiatric evaluation.
- •Had the start of their first schizophrenia episode ≤ 5 years before the time of consent.
- •Are 18 to 35 years old at the time of consent (inclusive, and outpatients only).
- •Have a Positive and Negative Syndrome Scale (PANSS) Total Score of ≤ 80 at screening and baseline.
- •Exhibit schizophrenia symptoms with a score ≥ 4 on the PANSS for ≥1 items related to active social avoidance, emotional withdrawal, passive/apathetic social withdrawal, and difficulty in abstract thinking.
- •Have a diagnosis of schizophrenia made at least 6 months prior to screening as confirmed by subject, caregiver, or documented history.
排除标准
- •Subjects presenting with a first episode of schizophrenia based on the clinical judgment of the investigator.
- •Subjects who have been hospitalized for psychotic symptoms within the last 6 months.
- •Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history or who have a history of failure to respond to clozapine or response to clozapine treatment only.
- •Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, MDD, bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders.
- •Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that require treatment with an antidepressant.
- •Subjects with clinically significant tardive dyskinesia at enrollment, as determined by a score of>= 3 on Item 8 of the AIMS at screening or baseline.
- •Subjects with a score of 5 (severe akathisia) on the BARS global clinical assessment of akathisia at screening or baseline.
- •Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding nicotine.
研究组 & 干预措施
Brexpiprazole
Experimental
Up to 4 mg/day, once daily dose, tablets, orally
干预措施: Brexpiprazole (Drug)
结局指标
主要结局
Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: Baseline and Week 16
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
次要结局
- Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score(Baseline and Week 16)
- Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score(Baseline and Week 16)
- Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures)(Baseline and Week 16)
- CGI-I Response Rate(Weeks 4, 8, 12, and 16)
- Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores(Baseline and Week 16)
- Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT)(Baseline and Week 16)
- Mean Change From Baseline to Week 16 Scores of the Following Negative Scale Items: Active Social Avoidance, Emotional Withdrawal, Passive/Apathetic Social Withdrawal, and Difficulty in Abstract Thinking(Baseline and Week 16)
- Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score(Baseline and Week 16)
- Mean Clinical Global Impression-Improvement (CGI-I) Score(Week 1 to Week 16)
- Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score(Baseline and Week 16)
- Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score(Baseline and Week 16)
- Mean Change From Baseline to Week 16 in Money Delay Discounting Task(Baseline and Week 16)
- Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time)(Baseline and Week 16)
- Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores(Baseline and Week 16)
- Mean Change From Baseline to Week 16 in Food Delay Discounting Task(Baseline and Week 16)
- Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item(Baseline and Week 16)
研究者
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