A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 for Treatment Augmentation in Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 129
- 主要终点
- Change From Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of filorexant (MK-6096) versus placebo as adjunctive treatment for major depressive disorder (MDD), in participants who are partial responders to antidepressant monotherapy with one of identified selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or bupropion. The primary hypothesis of the study is that filorexant is superior to placebo as augmentation therapy with respect to change from baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score.
详细描述
Participants will continue to take their pretrial antidepressant medication as prescribed throughout the trial. Participants will be randomized in a 1:1 ratio to receive filorexant or placebo for a 6-week treatment period. Following completion of the treatment period, participants will enter a 2-week double-blind run-out period. During the run-out period, participants who received placebo in the 6-week treatment period will continue to receive placebo and participants who received filorexant in the 6-week treatment period will be randomized to receive either filorexant or placebo in a 1:1 ratio.
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
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is (a) male or (b) female and not of reproductive potential, or (c) female of reproductive potential has a serum beta-hCG level consistent with the nongravid state at screening and agrees to use acceptable contraception;
- •Current primary diagnosis of recurrent major depressive disorder, without psychotic features, with a current moderate or severe depressive episode;
- •Duration of the current major depressive episode must be at least 2 months but no more than 18 months at Screening;
- •Participant has undergone an adequate trial of an antidepressant (one of identified SSRIs or SNRIs, or bupropion) for the current depressive episode.
排除标准
- •Current primary psychiatric diagnosis other than major depression;
- •Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder;
- •Alcohol or other substance abuse or dependence (excluding nicotine);
- •Clinically significant abnormality or disease of the central nervous system (including dementia and other cognitive disorders or traumatic brain injury);
- •Imminent risk of self-harm or of harm to others;
- •Participant is a psychiatric inpatient;
- •Participant has been on continuous antidepressant treatment for >18 months prior to Screening visit;
- •Inadequate response to more than 3 adequate antidepressant trials (including the current antidepressant treatment trial) for treatment of the current depressive episode;
- •Participant ever received electroconvulsive therapy, transcranial magnetic stimulation, or vagal nerve stimulation for treatment of depression;
- •History of narcolepsy, cataplexy, circadian rhythm disorder, parasomnia, sleep-related breathing disorder, restless legs syndrome, periodic limb movement disorder, excessive daytime sleepiness or difficulty sleeping due to a medical condition;
- •Clinical, laboratory, or electrocardiogram (ECG) evidence of significant systemic disease;
- •Cardiovascular event (e.g., myocardial infarction) or procedure (e.g., coronary artery bypass surgery) within 3 months of study;
- •History of malignancy ≤5 years prior to study, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer;
- •Body Mass Index >40 kg/m^2;
- •Pregnancy, breast-feeding, or expecting to become pregnant.
研究组 & 干预措施
Filorexant 10 mg (Treatment Phase)
Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
干预措施: Filorexant (Drug)
Placebo (Treatment Phase)
Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
干预措施: Placebo (Drug)
Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)
Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
干预措施: Filorexant (Drug)
Filorexant 10 mg/Placebo (Run-out Phase)
Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
干预措施: Filorexant (Drug)
Filorexant 10 mg/Placebo (Run-out Phase)
Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
干预措施: Placebo (Drug)
Placebo/Placebo (Run-out Phase)
Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline and Week 6
The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with total scores ranging from 0 to 60; higher scores correspond to greater symptom severity. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.
Number of Participants With an Adverse Event (AE) During Treatment Phase
时间窗: Up to Week 6
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the treatment phase (up to study Week 6) are counted once in this summary.
Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Phase
时间窗: Up to Week 6
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the treatment phase (up to study Week 6) are counted once in this summary.
Number of Participants With an AE During Run-out Phase
时间窗: From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks)
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the 2-week run-out phase and/or during the 2-week follow up after the last dose of study drug, are counted once in this summary.
Number of Participants Who Discontinued Study Drug Due to an AE During Run-out Phase
时间窗: From first run-out dose (following Week 6 visit) up to Week 8 (2 weeks)
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) or a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the 2-week run-out phase are counted once in this summary.
次要结局
- Change From Baseline to Week 6 in MADRS Total Score Excluding the Sleep Item(Baseline and Week 6)
- Change From Baseline to Week 6 in the Hamilton Depression Rating Scale, 17-item Version (HAM-D17) Bech Subscale Score(Baseline and Week 6)
- Percentage of Participants With HAM-D17 Remission (HAM-D17 Total Score ≤7) at Week 6(Week 6)