Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Long-term Study to Evaluate the Maintenance of Efficacy and Safety of 1 to 3 mg/Day of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,986
- 试验地点
- 107
- 主要终点
- Full Remission During the Randomised Treatment Period
研究概览
简要总结
To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).
详细描述
The total duration of the study was 32 weeks and the study consisted of Periods A, B, and A+. Patients entered the study in Period A and were treated open-label with one of six commercially available antidepressant treatments (ADTs) for 8 weeks. Patients who met the blinded response criteria at the Week 6 Visit, were deemed early responders and were withdrawn from the study. At Week 8, patients with inadequate response to placebo + ADT, as per the randomisation criteria, entered Period B and were randomised to received double-blind brexpiprazole + ADT or placebo + ADT for 24 weeks. Non-randomised patients continued in Period A+ and received placebo + ADT until the end of the study. The primary objective was to compare the efficacy and safety of brexpiprazole with placebo. This comparison occurred Period B; therefore, the focus is Period B.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is an outpatient consulting a psychiatrist.
- •The patient has an MDD diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- •The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressant treatments.
- •The patient agrees to protocol-defined use of effective contraception.
排除标准
- •The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD.
- •The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder.
- •The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE.
- •The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
- •The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
- •The patient has had neuroleptic malignant syndrome.
- •The patient has any relevant medical history or current presence of systemic disease.
- •The patient has, at the Screening Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
- •The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of IMP.
- •The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
干预措施: Placebo (Drug)
Placebo
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
干预措施: ADT (Drug)
Brexpiprazole
Brexpiprazole adjunct to open-label treatment with a commercially available ADT
干预措施: Brexpiprazole (Drug)
Brexpiprazole
Brexpiprazole adjunct to open-label treatment with a commercially available ADT
干预措施: ADT (Drug)
结局指标
主要结局
Full Remission During the Randomised Treatment Period
时间窗: From randomisation to end of Period B (24 weeks)
Full remission is defined as a Montomery and Åsberg Depression Rating Scale (MADRS) total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomized treatment. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.
次要结局
- Full Functional Remission During the Randomised Treatment Period(From randomisation to end of Period B (24 weeks))
- Full Global Score Remission During the Randomised Treatment Period(From randomisation to end of Period B (24 weeks))
- Total Time in Remission During the Randomised Treatment Period(From randomisation to end of Period B (24 weeks))
- Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period(From randomisation to end of Period B (24 weeks))
- Time to Full Remission During the Randomised Treatment Period(From randomisation to end of Period B (24 weeks))
- Full Remission Sustained During the Randomised Treatment Period(From randomisation to end of Period B (24 weeks))
- Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period(From randomisation to week 6)
- Response at Week 6 During the Randomised Treatment Period(From randomisation to week 6)
- Response at Week 24 During the Randomised Treatment Period(From randomisation to end of Period B (24 weeks))
- Remission at Week 6 During the Randomised Treatment Period(From randomisation to week 6)
- Remission at Week 24 in the Randomised Treatment Period(From randomisation to end of Period B (24 weeks))
- Change From Randomisation to Week 6 in SDS Total Score During the Randomised Treatment Period(From randomisation to week 6)
- Change From Randomisation to Week 24 in SDS Total Score During the Randomised Treatment Period(From randomisation to end of Period B (24 weeks))
- Change From Randomisation to Week 6 in CGI-S Score During the Randomised Treatment Period(From randomisation to week 6)
- Change From Randomisation to Week 24 in CGI-S Score During the Randomised Treatment Period(From randomisation to end of Period B (24 weeks))
- Change From Randomisation to Week 6 in Q-LES-Q (SF) Total Score During the Randomised Treatment Period(From randomisation to week 6)
- Change From Randomisation to Week 24 in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q (SF)) Total Score During the Randomised Treatment Period(From randomisation to end of Period B (24 weeks))