NCT04080752已完成2 期
Double-Blind, Placebo-Controlled, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-61393215 as Adjunctive Treatment in Adults With Major Depressive Disorder With Anxious Distress With Suboptimal Response to Standard Antidepressants
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 33
- 主要终点
- Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score at Week 6
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive disorder (MDD) with anxious distress with a score greater than or equal to (>=) 2 on item 26 or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have a suboptimal response to current treatment with a standard antidepressant.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a body mass index (BMI) between 18 and 36 kilogram per meter square (kg/m^2)
- •Participants must have a primary diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) diagnosis of major depressive disorder (MDD) with anxious distress, as assessed by the mini international neuropsychiatric inventory 7.
- •Plus (MINI). Participants with a diagnosis of comorbid generalized anxiety disorder (GAD), post-traumatic stress disorder, persistent depressive disorder, attention deficit hyperactivity disorder (ADHD), social anxiety disorder or nicotine/caffeine dependence may be included, if MDD is primary diagnosis
- •Participants must have an inventory of depressive symptomatology, clinician rating-30 (IDS-C30) total score greater than or equal to (>=) 35 (moderate to severe depression)
- •Participant must not have received more than 3 failed antidepressant treatments (of adequate dose and duration), including their current treatment, in the current episode of depression, as documented by the massachusetts general hospital antidepressant treatment history questionnaire (MGH-ATRQ)
- •Participant must be currently receiving 1 of the following antidepressants for at least 6 weeks duration at screening, at an adequate therapeutic dose, as determined by the MGH-ATRQ and should remain on a stable dose throughout the study: bupropion, citalopram, escitalopram, sertraline, paroxetine, venlafaxine, desvenlafaxine, duloxetine, fluoxetine, vilazodone, vortioxetine, mirtazapine, agomelatine, nortriptyline, imipramine, amitriptyline and levomilnacipran
- •Participants must have a suboptimal response (improvement <50%) to the antidepressant used as their current treatment, as measured by the MGH-ATRQ
- •A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose
排除标准
- •Participant has any other psychiatric condition including but not limited to: MDD with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (example: bulimia, anorexia nervosa), or schizophrenia (lifetime)
- •Age of onset of depression is after 55 years of age
- •Participant has a history of alcohol or substance use disorder (abuse/dependence) within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
- •Participant has a current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of >= 3 for ideation) or any suicidal behavior within the past year, as validated on the Colombia suicide severity rating scale (C-SSRS) at screening or baseline
- •Length of current major depressive episode >60 months
- •Participant has organic brain disease or dementia or has known or suspected intellectual development disorder
- •Participant has been treated with at least one of the following treatments: (a) electroconvulsive therapy in the current episode; (b) deep brain stimulation (lifetime); (c) repetitive transcranial magnetic stimulation within 4 weeks prior to baseline visit
- •Participant has any clinically relevant medical condition that could potentially alter the absorption, metabolism, or excretion of the study intervention, such as liver disease or renal disease
- •Participant has a relevant history of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures - uncomplicated childhood febrile seizures with no sequelae are not exclusionary) or significant cerebrovascular, renal, hepatic, dermatologic, hematologic, gastrointestinal or endocrine diseases. Hospitalization for cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack) within 3 months prior to the first administration of study drug is exclusionary. Diabetes mellitus be allowed when the participant is stable (HbA1c less than 7.5% or 58 mmol/mol)
- •Participant has a clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening or baseline Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable.If at screening visit QTcB or QTcF interval >=450 ms for males or >=470 ms for females, or >480 ms if bundle branch block and prolongation of the QTc interval are present;participant is excluded
- •Participant has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis
研究组 & 干预措施
JNJ-61393215 135 milligram (mg)
Experimental
Participants will receive JNJ-61393215 135 mg (3*45 mg capsules) orally once daily for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.
干预措施: JNJ-61393215 (Drug)
Placebo
Placebo Comparator
Participants will receive matching placebo for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score at Week 6
时间窗: Baseline and Week 6
Change from baseline in HDRS-17 total score at Week 6 was reported. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).
次要结局
- Change From Baseline in HDRS-17 Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6(Baseline and Week 6)
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 6(Baseline and Week 6)
- Change From Baseline in HAM-A Total Score at Weeks 2 and 4(Baseline, Week 2, and Week 4)
- Change From Baseline in HAM-A Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6(Baseline and Week 6)
- Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score at Week 6(Baseline and Week 6)
- Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 2 and 4(Baseline, Week 2, and Week 4)
- Change From Baseline in HDRS-17 Total Score at Weeks 2 and 4(Baseline, Week 2, and Week 4)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability(Up to 8 weeks)
- Total Plasma Concentration of JNJ-61393215(1-4 hours postdose on Day 1; Predose and 1-4 hours post dose on Days 15, 29, and 43)
- Plasma Protein Binding (PPB): Percentage of JNJ-61393215 Unbound(Predose and 1-4 hours post dose on Day 43)
研究者
研究点 (33)
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