A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 9
- 主要终点
- Change From Baseline in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score at Week 12
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).
详细描述
Eligible participants for this study must have a diagnosis of current IED.
This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.
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
- Triple (Participant, 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
- •Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version
- •At least 3 IED days (at least 1 IED episode each day, as recorded by the participant) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator
- •Score ≥ 12 on the Life History of Aggression scale at screening
- •Score ≥ 6 on the Overt Aggression Scale - Modified Total Irritability at screening and baseline
- •Score ≥ 4 on the modified Clinical Global Impression of Severity for IED at screening and baseline
排除标准
- •Diagnosis of major depressive disorder within 6 months of screening
- •Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 score ≥ 10 at screening
- •Met only the DSM-5 A2 criterion for IED
- •Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)
- •Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)
研究组 & 干预措施
AVP-786
Participants were to receive AVP-786-28 (deudextromethorphan hydrobromide [d6-DM] 28 milligrams [mg]/quinidine sulfate [Q] 4.9 mg) once daily (OD) for the first 7 days, followed by AVP-786-28 twice daily (BID) for the next 7 days. Beginning on Day 15, participants were to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) BID for 10 weeks.
干预措施: AVP-786 (Drug)
Placebo
Participants were to receive placebo BID for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score at Week 12
时间窗: Baseline; Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M aggression domain includes 4 items: verbal assault, assault against objects, assault against others, and assault against self. The rater determines the frequency of each response (item) during the past week, and the frequency of each item is multiplied by the severity level (0 to 5), producing a raw score. This raw score is multiplied by severity weight for that item (verbal assault x 1, assault against objects x 2, assault against others x 3, and assault against self x 3). Each response is scored using a 6-point scale (0 = no events to 5 = most severe form of assault within that category). The weighted individual item scores are added to obtain the OAS-M Total Aggression score. Higher scores indicate increased aggression.
次要结局
- Change From Baseline in the OAS-M Total Irritability Score at Week 12(Baseline; Week 12)
- Change From Baseline in the Severity of IED Episodes at Week 12(Baseline; Week 12)
- Change From Baseline in the Short-Form 12-Item Health Survey (SF-12) Score at Week 12(Baseline; Week 12)
- Change From Baseline in the OAS-M Individual Items for Aggression at Week 12(Baseline; Week 12)
- Change From Baseline in the OAS-M Individual Items for Irritability at Week 12(Baseline; Week 12)
- Change From Baseline in the Number of Intermittent Explosive Disorder (IED) Days Documented by Participants at Week 12(Baseline; Week 12)
- Change From Baseline in the Number of IED Days as Assessed by the Investigator at Week 12(Baseline; Week 12)
- Change From Baseline in the Number of IED Episodes at Week 12(Baseline; Week 12)
- Change From Baseline in the Severity of Distress From Episodes at Week 12(Baseline; Week 12)
- Change From Baseline in the OAS-M: Number of Discrete IED Episodes at Week 12(Baseline; Week 12)
- Change From Baseline in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED at Week 12(Baseline; Week 12)
- Change From Baseline in the Modified Patient Global Impression of Change (mPGI-C) Score for IED at Week 12(Baseline; Week 12)
- Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12(Baseline; Week 12)
- Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12(Baseline; Week 12)
- Change From Baseline in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED at Week 12(Baseline; Week 12)
- Change From Baseline in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED at Week 12(Baseline; Week 12)