A Double-Blind, Placebo-Controlled Study of Caplyta in the Treatment of Borderline Personality Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Zanarini Rating Scale for Borderline Personality Disorder
研究概览
简要总结
The primary objective of the proposed study is to evaluate the safety and efficacy of Caplyta (lumateperone) in adults with borderline personality disorder (BPD). Sixty subjects with BPD will be randomized in a 1:1 fashion to either Caplyta (42mg/day) or matching placebo for 8 weeks of active treatment. The hypothesis to be tested is that Caplyta will result in greater rates of reduction in symptoms of BPD compared to placebo (improvement in symptoms will be indicated by lower scores on established outcome measures of BPD symptoms that have been used in prior studies).
详细描述
Borderline personality disorder (BPD) is a serious, difficult to treat, psychiatric disorder that causes significant emotional distress, as well as resulting in significant economic burden to health care systems. A variety of psychotherapies, particularly dialectical behavior therapy (DBT) and systems training for emotional predictability and problem solving (STEPPS), have shown benefit in reducing many of the core symptoms of BPD. Healthcare systems, however, often lack the funding and appropriate expertise to implement these treatments, and finding trained DBT or STEPPS therapists has been difficult for many people with BPD. While research on the use of medication is ongoing, no drug has yet been approved in the United States or elsewhere for the treatment of BPD. Antidepressants, anti-convulsants, and second generation antipsychotics have all been examined, but current medication options for BPD often provide only partial relief and may have pronounced side effects.
BPD is characterized by a pervasive pattern of severe psychopathological symptoms with instability of affect regulation, impulse control, and aggression. Dysfunctions in the serotoninergic, dopaminergic, and glutamatergic systems have been demonstrated in-and considered as possible causes for-symptoms associated with the disorder. Caplyta (lumateperone) therefore has distinctive properties that make it a promising option for patients with BPD. Caplyta is a mechanistically novel agent as it simultaneously modulates serotonin, dopamine, and glutamate, the key neurotransmitters implicated in BPD. Specifically, Caplyta acts as a potent serotonin 5-HT2A receptor antagonist, a dopamine D2 receptor pre-synaptic partial agonist and post-synaptic antagonist, a D1 receptor-dependent modulator of glutamate, and a serotonin reuptake inhibitor. In addition, because of low rates of side effects, Caplyta should be a well-tolerated and in fact desired medication approach to BPD.
The aim of the present study is to examine the efficacy and safety of Caplyta vs. placebo in adults with BPD, as indicated by a score of at least 9 on the Zanarini Rating Scale for Borderline Personality Disorder ("Zanarini scale"), a scale of illness severity, at the baseline visit.
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
- •Men and women age 18-65;
- •Primary diagnosis of BPD
- •Zanarini scale score of at least 9 at baseline
- •Currently receiving for at least the last 2 months prior to study entry some form of weekly cognitive behavioral therapy
- •Ability to understand and sign the consent form.
排除标准
- •Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
- •Subjects with schizophrenia or bipolar I disorder
- •Subjects with an active substance use disorder
- •Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- •Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
- •Illegal substance use based on urine toxicology screening (excluding marijuana given the high rates of marijuana use in BPD and the lack of interaction with Caplyta).
- •Use of any new psychotropic medication started within the last 3 months prior to study initiation
- •Previous treatment with Caplyta
- •Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
研究组 & 干预措施
Caplyta
All subjects who are randomized to Caplyta will receive 42mg/day starting the first week of the study. Subjects will be seen every two weeks for 8 weeks. Dosage changes and reductions will not be permitted. After study conclusion (week 8), the dose will be discontinued.
干预措施: Caplyta (Drug)
Placebo
All subjects who are randomized to Placebo will receive an identical placebo pill to the experimental drug starting the first week of the study. Subjects will be seen every two weeks for 8 weeks. After study conclusion (week 8), the dose will be discontinued.
干预措施: Placebo (Drug)
结局指标
主要结局
Zanarini Rating Scale for Borderline Personality Disorder
时间窗: 8 Weeks
A clinician-administered scale assessing Borderline Personality Scale severity
次要结局
- Quality of Life Inventory(8 Weeks)
- Modified Overt Aggression Scale(8 Weeks)
- Self-Report Version of Zanarini Scale(8 Weeks)
- Barratt Impulsiveness Scale (BIS)(8 Weeks)
- Hamilton Depression Rating Scale(8 Weeks)
- Young Mania Rating Scale(8 Weeks)
- Minnesota Impulsive Disorders Interview (MIDI)(8 Weeks)
- Hamilton Anxiety Rating Scale(8 Weeks)
- Sheehan Disability Scale (SDS)(8 Weeks)
- Borderline Evaluation of Severity Over Time(8 Weeks)
- Symptom Checklist-90-Revised (SCL-90-R)(8 Weeks)
- Change in Borderline Evaluation of Severity Over Time (BEST) Total Score(8 weeks)
- Minnesota Impulsive Disorders Interview (MIDI)(Baseline)