A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,022
- 试验地点
- 85
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period
研究概览
简要总结
The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD
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
- •Patients who have provided consent prior to any specific procedure
- •Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
- •Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2
排除标准
- •Patients who do not meet DSM-IV-TR criteria for MDD
研究组 & 干预措施
Placebo + ADT Lead-in
Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.
干预措施: Placebo (Drug)
Placebo + ADT Lead-in
Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.
干预措施: Antidepressant Therapy (ADT) (Drug)
Placebo + ADT (Double-Blind)
Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).
干预措施: Placebo (Drug)
Placebo + ADT (Double-Blind)
Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).
干预措施: Antidepressant Therapy (ADT) (Drug)
Cariprazine + ADT (Double-Blind)
Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).
干预措施: Cariprazine (Drug)
Cariprazine + ADT (Double-Blind)
Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).
干预措施: Antidepressant Therapy (ADT) (Drug)
Placebo + ADT (Continued Treatment)
Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.
干预措施: Placebo (Drug)
Placebo + ADT (Continued Treatment)
Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.
干预措施: Antidepressant Therapy (ADT) (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period
时间窗: Baseline (Week 8)
The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period
时间窗: Baseline (Week 8) to Week 16
The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. A negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.
次要结局
- Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period(Baseline (Week 8) to Week 16)