NCT01197508已完成3 期
A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 696
- 试验地点
- 1
- 主要终点
- Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.
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 a medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.
详细描述
A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
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.
- •History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product.
研究组 & 干预措施
0.1 mg BID TC-5214
Experimental
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
干预措施: TC-5214 (Drug)
1 mg BID TC-5214
Experimental
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
干预措施: TC-5214 (Drug)
4 mg BID TC-5214
Experimental
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
干预措施: TC-5214 (Drug)
Placebo
Placebo Comparator
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
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.
时间窗: Randomization (Week 8) to end of treatment (Week 16)
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
次要结局
- Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)(Randomization (Week 8) to end of treatment (Week 16))
- Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score(Randomization (Week 8) to end of treatment (Week 16))
- Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)(Randomization (Week 8) to end of treatment (Week 16))
- Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)(Randomization (Week 8) to end of treatment (Week 16))
- Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)(Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16)
- Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)(Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16)
- Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score(Randomization (Week 8) to end of treatment (Week 16))
- Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)(Week 16)
- Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of "Very Much Improved" or "Much Improved" From Randomization (Week 8) to End of Treatment (Week 16)(Randomization (Week 8) to end of treatment (Week 16))
- Change in MADRS Total Score From Randomization (Week 8) to Week 10(Randomization (Week 8) to Week 10)
- Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score(Randomization (Week 8) to end of treatment (Week 16))
- Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)(Week 12, Week 14, Week 16)
- Change in MADRS Total Score From Randomization (Week 8) to Week 9(Randomization (Week 8) to Week 9)
- Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15(Randomization (Week 8) to end of treatment (Week 16))
- Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score(Randomization (Week 8) to end of treatment (Week 16))
- Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score(Randomization (Week 8) to end of treatment (Week 16))
- Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)(Randomization (Week 8) to end of treatment (Week 16))
- Change in MADRS Total Score From Randomization (Week 8) to Week 12(Randomization (Week 8) to Week 12)
- Change in MADRS Total Score From Randomization (Week 8) to Week 14(Randomization (Week 8) to Week 14)
- Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score(Randomization (Week 8) to end of treatment (Week 16))
- Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16(Randomization (Week 8) to end of treatment (Week 16))
研究者
研究点 (1)
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