NCT04100096已完成2 期
A Multicenter, Randomized, Flexible-dose, Double-blind Trial of Brexpiprazole Versus Placebo for the Treatment of Adults With Borderline Personality Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.75 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2019年10月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 75
- 主要终点
- Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score
研究概览
简要总结
There are currently no pharmacological treatments approved to treat borderline personality disorder (BPD). This trial will be conducted to evaluate the efficacy and safety of brexpiprazole for the treatment of participants diagnosed with BPD to provide a pharmacological treatment for BPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants, ages 18 to 65, inclusive, at the time of informed consent
- •Participants with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of BPD confirmed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) at screening.
- •At screening and Day 0, participants must have a total score ≥ 12 on the Zanarini Rating Scale for BPD (ZAN-BPD) scale.
- •Participants who, in the investigator's judgment, require treatment with a medication for BPD.
- •Participants willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
排除标准
- •Sexually active males or females of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of investigational medicinal product (IMP). Consensual sexual activity that cannot biologically result in pregnancy may not be participant to required birth control methods, following discussion with the medical monitor. Male participants must also agree not to donate sperm from trial screening through 30 days after the last dose of IMP.
- •Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
- •Participants with a concurrent DSM-5 diagnosis of schizophrenia or schizoaffective disorder. Also, participants with a concurrent diagnosis of bipolar I disorder, bipolar II disorder, delirium, dementia, amnesia, eating disorder, antisocial personality disorder, or other cognitive disorders.
- •Participants with a current diagnosis of substance or alcohol use disorder within 90 days prior to screening visit.
- •Participants who fulfill the following criteria related to suicide and/or suicidal ideation are excluded:
- •Participants who have a significant risk of committing violent acts, serious self-harm, or suicide based on history or routine psychiatric status examination, or those who are homicidal or considered to be a high risk to others, or participants with a response of "yes" on the Columbia-suicide severity rating scale (C-SSRS) Suicidal Ideation Item 5, OR
- •Participants with a response of "yes" on the C-SSRS Suicidal Behavior Items, OR
- •Participants who have had 3 suicide attempts, OR,
- •Participants who have had 3 or more hospitalizations due to suicidal behavior.
- •Participants who received brexpiprazole in any prior clinical trial or participants who have taken or are taking commercially available brexpiprazole (Rexulti®).
- •Participants who are currently either inpatient or partially hospitalized.
- •Participants who participated in a clinical trial within 90 days prior to screening or who participated in more than 2 clinical trials within a year prior to screening.
研究组 & 干预措施
Brexpiprazole 2-3 Milligrams Per Day
Experimental
Participants received brexpiprazole, 2-3 milligrams per day (mg/day) tablets, orally, up to Week 12 during the treatment phase.
干预措施: Brexpiprazole (Drug)
Placebo
Placebo Comparator
Participants received brexpiprazole-matching placebo tablets, orally, up to Week 12 during the treatment phase.
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score
时间窗: Baseline (Day 0) to Week 10
The ZAN-BPD is a clinician-administered scale designed to assess severity of disease symptoms in participants with BPD based on clinician rating on 9 criteria. Each of the 9 criteria for BPD was rated on a 5-point anchored rating scale of 0 to 4. These scores were clustered into 4 sector scores (akin to domains) and a total score. The 4 sector scores added up to provide the overall total score for the ZAN-BPD, which ranged from 0 to 36. A higher score represented a higher severity of disease symptoms. Mixed model repeated measures = MMRM, antidepressant therapy = ADT.
次要结局
- Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score(Baseline (Day 0) to Week 10)
- Number of Participants With Potentially Clinically Relevant Laboratory Test Values(From first dose of study drug up to Week 12)
- Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score(Baseline (Day 0), Weeks 6 and 12)
- Patient's Global Impression of Change (PGI-C) Scale Score(Weeks 2, 4, 6, 8,10 and 12)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From Baseline (Day 0) to 21 days after last dose (Up to Week 15))
- Change From Baseline in Body Weight(Baseline (Day 0), Weeks 2, 4, 6, 8, 10, and 12)
- Change From Baseline in Waist Circumference(Baseline (Screening: Day -21 to Day -1), Week 12)
- Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score(Baseline (Day 0), Weeks 6 and 12)
- Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs(From first dose of study drug up to Week 12)
- Number of Participants With Suicidal Behavior and Suicidal Ideation As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline (Day 0) to Week 12)
- Change From Baseline in the Patient's Global Impression of Severity (PGI-S)(Baseline (Day 0), Weeks 2, 4, 6, 8, 10 and 12)
- Clinical Global Impression - Improvement (CGI-I) Scale Score(Weeks 2, 4, 6, 8, 10 and 12)
- Number of Participants With Potential Clinical Relevant Laboratory Test Values - Prolactin(Week 12)
- Change From Baseline in Body Mass Index (BMI)(Baseline (Day 0), Weeks 2, 4, 6, 8, 10, and 12)
- Number of Participants With Potentially Clinically Relevant Abnormalities in 12-Lead Electrocardiogram (ECG) Parameters(Week 12)
- Change From Baseline in Simpson-Angus Scale (SAS) Total Score(Baseline (Day 0), Week 6 and 12)
研究者
研究点 (75)
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