A Phase 4, Multicenter, Open-label, Interventional Trial to Assess the Effects on Engagement of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy for the Treatment of Adults With Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change From Baseline in IDS-SR-10 Engagement
研究概览
简要总结
The clinical trial will investigate the effect of brexpiprazole on the concept of life engagement in participants with Major Depressive Disorder (MDD) with a current depressive episode.
详细描述
This is a phase 4, multicenter, open-label, flexible dose trial designed to assess the effects of brexpiprazole (flexible dose; 0.5 to 2 milligrams [mg], once daily [QD]) as adjunctive therapy to antidepressant therapy (ADT) on life engagement in participants with MDD. This trial is being conducted in line with the Canadian Product Monograph.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants (outpatients) between the regional age of majority (18 or 19 years of age) to 65 years of age, inclusive, at the time of informed consent.
- •Primary diagnosis of MDD and in a current non-psychotic major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, who have been outpatients for at least 4 weeks, and have an inadequate response, per investigator judgment, to 1 or 2 adequate treatments of ADTs in their current MDE, including current ADT.
- •Participants with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the screening and baseline visits, if separate.
排除标准
- •Participants currently or previously treated with brexpiprazole including participants who received brexpiprazole in any prior clinical trial.
- •Participants with a concurrent DSM-5 diagnosis of the following will be excluded:
- •Schizophrenia or schizoaffective disorder
- •Bipolar I or bipolar II disorder
- •Post-traumatic stress disorder
- •Eating disorder
- •Borderline personality disorder
- •Antisocial personality disorder
- •Participants with a suicidality score of 3 based on Inventory of Depressive Symptomatology Self-Report (IDS-SR) suicidality item 18 or participants who, in the opinion of the investigator, presents a serious risk of suicide.
研究组 & 干预措施
Brexpiprazole
Participants received brexpiprazole as a flexible dose; 0.5 mg to 2 mg, orally (PO), QD, and continued on the stable dose of ADT up to 8 weeks.
干预措施: Brexpiprazole (Drug)
结局指标
主要结局
Change From Baseline in IDS-SR-10 Engagement
时间窗: Baseline to Week 8
The IDS-SR-10 engagement consist of selected 10 item scores, including the following 10 items (clinician-selected): item 8 - Response of your mood to good or desired events, item 15 - Concentration/decision making, item 16 - View of myself, item 17 - View of my future, item 19 - General interest, item 20 - Energy level, item 21 - Capacity for pleasure or enjoyment (excluding sex), item 22 - Interest in sex (interest rated, not activity), item 23 - Feeling slowed down, and item 29- Interpersonal sensitivity. All the 10 items are rated on a 0 (best) to 3 (worst) scale. IDS-SR-10 engagement total score ranges from 0 (best) to 30 (worst). A negative change from baseline indicated improvement. Least square (LS) mean was calculated using a mixed model repeated measure (MMRM) analysis.
Change From Baseline in IDS-SR Total Score
时间窗: Baseline to Week 8
The IDS-SR is a 30-item self-report measure that was used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorder (MDD). Each item on the IDS-SR scale was rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. IDS-SR total score is the sum of ratings of 28 item scores with the total score ranging from 0 (best) to 84 (worst). Under item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. A negative change from baseline indicated improvement. LS mean was calculated using a MMRM analysis.
次要结局
未报告次要终点