A Single Dose, 4-way Crossover, Placebo-controlled, Randomized Study to Investigate the Effect of JNJ-42847922 on Polysomnography (PSG) Measures in Subjects With Major Depressive Disorder With Insomnia Who Are Stably Treated With Antidepressants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Latency to Persistent Sleep (LPS) on Day 1
研究概览
简要总结
The purpose of the study is to evaluate effect of JNJ-42847922 on sleep latency (latency to persistent sleep) in participants with major depressive disorder who are stably treated with selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor who suffer from insomnia (inability to fall asleep).
详细描述
This is a double-blind (neither physician nor participants knows the treatment that the participant receives), placebo-controlled (placebo is compared with the study medication to test whether the study medication has a real effect in clinical study), randomized (the study medication is assigned by chance) 4-way crossover (method used to switch participants to 4 different arms in a clinical study), and a single dose study. This study will consist of a screening phase (between 28 to 2 days prior to the study medication), a treatment phase of 4 double blind study periods (2 days), and a follow-up phase (within 7 to 14 days after last dose of the study medication). Approximately 20 participants with major depressive disorder will participate in this study. Participants will be randomly assigned to 1 of 4 cohorts (groups) (Cohorts A, B, C, and D) to receive JNJ-42847922 (10 mg, 20 mg, and 40 mg) and placebo. Each cohort consists of 4 treatment periods (Periods 1, 2, 3, and 4). Safety will be evaluated by the assessment vital signs, 12-lead electrocardiogram, clinical laboratory testing, physical examination, and neurological examination. The total duration of study participation for a participant will be approximately 9 to 10 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a current/recurrent or past episode of Major Depressive Disorder (MDD) as established per mini international neuropsychiatric interview at screening or otherwise specified by the treating physician
- •Stably treated with selective serotonin re-uptake inhibitor / serotonin-norepinephrine reuptake inhibitor monotherapy, with no change in dose in the last 30 days before screening
- •Insomnia per polysomnography (a diagnostic test to measure and record physiologic variables like latency to persistent sleep, total sleep time, sleep efficiency, time spent awake, and total time spent in deep sleep, during sleep)
- •Participants must be healthy / medically stable on the basis of clinical laboratory tests performed at screening
- •Female participants should not be of child bearing potential due to either tubal ligation or hysterectomy or who are postmenopausal (no spontaneous menses for at least 2 years)
排除标准
- •Has a current diagnosis of a psychotic disorder, MDD with psychosis, bipolar disorder, mental retardation, or cluster B personality disorder (eg, borderline personality disorders, antisocial personality disorder)
- •Has been diagnosed with sleep-related breathing disorder
- •Has suicidal ideation with some intent to act, or has homicidal ideation/intent, per Principal Investigator's clinical judgment
- •Abnormal day/night rhythm, eg, nightshift worker, or normal bed time past midnight
- •Has uncontrolled hypertension at screening and Day 1 prior to randomization; or any past history of hypertensive crisis
研究组 & 干预措施
Cohort A
5 participants will be included in this cohort. Participants will receive the study medications in the sequence of placebo (Period 1), JNJ-42847922 10 mg (Period 2), JNJ-42847922 20 mg (Period 3), and JNJ-42847922 40 mg (Period 4). Each treatment period and each subsequent treatment period will be separated by 1 week.
干预措施: JNJ-42847922 (Drug)
Cohort A
5 participants will be included in this cohort. Participants will receive the study medications in the sequence of placebo (Period 1), JNJ-42847922 10 mg (Period 2), JNJ-42847922 20 mg (Period 3), and JNJ-42847922 40 mg (Period 4). Each treatment period and each subsequent treatment period will be separated by 1 week.
干预措施: Placebo (Other)
Cohort B
5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 10 mg (Period 1), JNJ-42847922 40 mg (Period 2), placebo (Period 3), and JNJ-42847922 20 mg (Period 4). Each subsequent treatment period will be separated by 1 week.
干预措施: JNJ-42847922 (Drug)
Cohort B
5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 10 mg (Period 1), JNJ-42847922 40 mg (Period 2), placebo (Period 3), and JNJ-42847922 20 mg (Period 4). Each subsequent treatment period will be separated by 1 week.
干预措施: Placebo (Other)
Cohort C
5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 20 mg (Period 1), placebo (Period 2), JNJ-42847922 40 mg (Period 3), and JNJ-42847922 10 mg (Period 4). Each subsequent treatment period will be separated by 1 week.
干预措施: JNJ-42847922 (Drug)
Cohort C
5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 20 mg (Period 1), placebo (Period 2), JNJ-42847922 40 mg (Period 3), and JNJ-42847922 10 mg (Period 4). Each subsequent treatment period will be separated by 1 week.
干预措施: Placebo (Other)
Cohort D
5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 40 mg (Period 1), JNJ-42847922 20 mg (Period 2), JNJ-42847922 10 mg (Period 3), and placebo (Period 4). Each subsequent treatment period will be separated by 1 week.
干预措施: JNJ-42847922 (Drug)
Cohort D
5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 40 mg (Period 1), JNJ-42847922 20 mg (Period 2), JNJ-42847922 10 mg (Period 3), and placebo (Period 4). Each subsequent treatment period will be separated by 1 week.
干预措施: Placebo (Other)
结局指标
主要结局
Latency to Persistent Sleep (LPS) on Day 1
时间窗: Day 1
LPS is with lights off, appearance of first epoch of Stage 1 (light sleep), Stage 2 (light sleep), Stage 3 (deep sleep), and Stage 4 (rapid eye movement sleep) sleep followed by at least 20 consecutive epochs without any Stage 0 sleep (awake but sleepy). LPS will be accessed on Day 1 of each treatment period (Periods 1, 2, 3, and 4).
次要结局
- Area Under the Plasma Concentration-Time Curve From Time Zero to Time 12 (AUC[12])(Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours))
- Total sleep time in participants(Screening (Day -28 to Day -2), Day 1, and Day 2)
- Time spent awake by the participants(Screening (Day -28 to Day -2) and Day 1)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-42847922(Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours))
- Number of participants with adverse events(Up to Week 10)
- Maximum Observed Plasma Concentration (Cmax) of JNJ-42847922(Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours))
- Total amount of JNJ-42847922 excreted in urine (Ae12)(Predose and postdose Day 1)
- Renal clearance (CLR)(Predose and postdose Day 1)
- Number of participants with suicidal ideation or behavior measured using Columbia Suicide Severity Rating Scale (C-SSRS)(Screening (Day -28 to Day -2), Day 1, and Day 2)
- Sleep efficiency in participants(Screening (Day -28 to Day -2), Day 1, and Day 2)
- Next-day residual effect of JNJ-42847922 measured using visual analogue scale (VAS) for sleepiness(Screening (Day -28 to Day -2), Day 1, and Day 2)
- Next-day residual effect of JNJ-42847922 measured using the Bond and Lader visual analogue scale (VAS) to rate subjective feelings(Screening (Day -28 to Day -2), Day 1, and Day 2)
- Concentration of cortisol in saliva(Predose Day 1 (30 minutes and 90 minutes) and postdose Day 2 (at wake-up and 30 minutes after wake-up))
- Next-day residual effect of JNJ-42847922 on body movements measured using a pot string meter and a stabilometric platform(Screening (Day -28 to Day -2), Day 1, and Day 2)
- Next-day residual effect of JNJ-42847922 on saccadic eye movements(Screening (Day -28 to Day -2), Day 1, and Day 2)
- Number of participants with depressive symptoms measured using Quick Inventory of Depressive Symptomatology - Self Report 14-item (QIDS-SR14)(Screening (Day -28 to Day -2), Day 1, and Day 2)
- Total time spent deep sleep by the participants(Screening (Day -28 to Day -2) and Day 1)