NCT01156415终止3 期
A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 837
- 试验地点
- 97
- 主要终点
- Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale
研究概览
简要总结
The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase.
Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study.
Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Key Inclusion Criteria Cohort I:
- •Documentation of completion of a Novartis AGO178C Double-blind Study in MDD patients.
- •Male and female adults, 18 through 71 years of age, inclusive (i.e., same age range as for Double-blind Study, but with upper age limit increased by 1-year to accommodate patients whose age increased during the Double-blind Study).
- •Female patients should continue to use effective contraception as defined in double-blind study protocol.
- •Inclusion Criteria:
- •Key Inclusion criteria Cohort II:
- •Male and female adults, 18 through 70 years of age, inclusive.
- •Diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
- •Current episode ≥4 weeks.
- •CGI-Severity score ≥4 at Screening and Baseline.
排除标准
- •Key Exclusion Criteria Cohort I:
- •Concomitant use of fluvoxamine.
- •Any significant medical condition that emerged during Double-blind Phase of a previous study, which may interfere with study participation and/or study assessments as assessed by the investigator.
- •Exclusion Criteria:
- •Key Exclusion criteria Cohort II:
- •History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.
- •Any other current Axis I disorder other than MDD which is the focus of treatment.
- •Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.
- •Prior exposure to agomelatine.
- •Female patients of childbearing potential who are not using effective contraception.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Agomelatine (AGO178) 0.5 mg
Experimental
干预措施: AGO178 (Drug)
Agomelatine (AGO178) 1 mg
Experimental
干预措施: AGO178 (Drug)
结局指标
主要结局
Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale
时间窗: 52 weeks
次要结局
- Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale(Week 6, 8, 12, 28, 36 and 52)
- Proportion of patients who demonstrate clinical improvement at Week 6,8,12, 28,36 and 52, where improvement is defined by a score of 1 or 2 on the CGI-I scale(Week 6, 8, 12, 28, 36 and 52)
- Overall illness severity as measured by change from Baseline on CGI-S (Clinical Global Impression of severity scale) at week 52(Week 52)
- Patients' ability to function in daily life as measured by change from Baseline on total score of Sheehan Disability Scale at week 52(Week 52)
研究者
研究点 (97)
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