A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III, Long-Term Safety and Tolerability Study of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 813
- 试验地点
- 1
- 主要终点
- Frequency of Patients Experiencing Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken for 52 weeks with another antidepressant medicine.
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
- Quadruple (Participant, Care Provider, 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
- •Provision of signed and dated informed consent before initiation of any study-related procedures.
- •The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
- •Outpatient status at enrollment and randomization.
排除标准
- •Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
- •Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
- •Patients with significant liver, kidney, lung, heart, neurological, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
研究组 & 干预措施
SSRI/Serotonin/SNRI + TC-5214 1-4 mg
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214 1-4 mg BID
干预措施: TC-5214 (Drug)
SSRI/Serotonin/SNRI + placebo
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + placebo BID
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of Patients Experiencing Serious Adverse Events (SAEs)
时间窗: Randomization (Week 0) to end of the follow-up period (Week 54)
The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.
Frequency of Patients Experiencing at Least One Adverse Event (AE)
时间窗: Randomization (Week 0) to end of the follow-up period (Week 54)
The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.
Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
时间窗: Randomization (Week 0) to end of the follow-up period (Week 54)
The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
次要结局
- Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24(Week 12 to Week 24)
- Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score(Randomization (Week 0) to end of treatment (Week 52))
- Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)(Randomization (Week 0) to end of treatment (Week 52))
- Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52(Week 12 to Week 52)
- Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52)(Randomization (Week 0) to end of treatment (Week 52))
- Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score(Randomization (Week 0) to end of treatment (Week 52))