NCT02013531已完成3 期
Protocol 331-13-002: An Exploratory, Multicenter, Open-label, Flexible-dose Trial of Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms
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
- 37
- 主要终点
- Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.
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
- •Have a diagnosis of a single or recurrent, nonpsychotic episode of MDD 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.) and an adequate clinical psychiatric evaluation.
- •Have a treatment history of an inadequate ADT response to at least 1 ADT (but not > 3) for the current episode.
- •Have received a single, trial-approved, SSRI or SNRI at an adequate dose for
- •≥ 6 weeks prior to screening.
- •Are 18 to 65 years old at the time of consent (inclusive, and outpatients only).
- •Have a Hamilton Depression Rating Scale (HAM-D)-17-item Total Score ≥ 18 at screening and baseline.
- •Have a Hamilton Anxiety Rating Scale (HAM-A) Total Score ≥ 20 at screening and baseline.
排除标准
- •Subjects with any of the following current Axis I DSM-IV-TR diagnoses:
- •other cognitive disorders
- •schizophrenia
- •schizoaffective disorder
- •other psychotic disorders
- •bipolar I disorder,
- •bipolar II disorder
- •bipolar disorder not otherwise specified (NOS)
- •eating disorders
- •anorexia nervosa
- •obsessive compulsive disorder
- •post-traumatic stress disorder
- •Subjects with any of the following current Axis II DSM-IV-TR diagnoses:
- •borderline, antisocial
- •schizotypal
- •histrionic personality disorders
- •mental retardation.
研究组 & 干预措施
Brexpiprazole
Experimental
Up to 3 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 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline, Week 6
The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, with higher values indicating worse outcome.
次要结局
- Mean Change From Baseline in Go/No-Go Task for Mean Reaction Time(Baseline, Week 6)
- Percentage of Participants With CGI-I Response Rate(Week 1 to Week 6)
- Mean Change From Baseline in Go/No-Go Task for P-inhibition Failures(Baseline, Week 6)
- Mean Change in Clinical Global Impression-Severity (CGI-S) Total Score(Baseline, Week 6)
- Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 6.(Baseline, Week 6)
- Percentage of Participants With a MADRS Response(Week 6)
- Percentage of Participants With a MADRS Remission(Week 6)
- Mean Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score(Baseline, Week 6)
- Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score(Baseline, Week 6)
- Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score(Baseline, Week 6)
- Mean Change From Baseline in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score(Baseline, Week 6)
- Mean Change From Baseline in Kellner Symptom Questionnaire (KSQ)(Baseline, Week 6)
- Mean Change From Baseline in Food Delay Discounting Task(Baseline, Week 6)
- Mean Change From Baseline in Money Delay Discounting Task(Baseline, Week 6)
- Mean Change From Baseline in Barratt Impulsiveness Scale 11-item (BIS-11) Total Score(Baseline, Week 6)
- Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Score(Baseline, Week 6)
- Mean Change From Baseline in Delay and Probability Discounting Task (DPDT) Scores(Baseline, Week 6)
- Mean Change From Baseline to Week 6 in the Number of Impulsive Choices in the Delayed Reward Task (DRT)(Baseline, Week 6)
研究者
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