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| ID | Type | Description | Link |
|---|---|---|---|
| 42847922ISM2002 | Other Identifier | Janssen Research & Development, LLC | |
| 2015-001672-22 | EudraCT Number |
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The primary purpose of this study is to investigate the effect of JNJ-42847922 (change versus placebo) on sleep efficiency (SE) measured by polysomnography (PSG) after single and multiple dose administration to participants with insomnia disorder without psychiatric comorbidity.
This is a multi-center, randomized (study medication assigned to participants by chance), placebo-controlled, double-blind (neither physician nor participant knows the identity of the assigned treatment), 2-way cross-over study of JNJ-42847922 participants with insomnia disorder without psychiatric comorbidity. The study consists of following phases: screening (28 days prior to Day 1), a double-blind treatment phase (consists of 5-day treatments, either JNJ-42847922 or placebo in subsequent 2-treatment periods, each separated with washout period of 5 to 9 days), and a follow-up examination (7 to 14 days after last dose administration). Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-42847922 then Placebo | Experimental | Participants receive 2*20 milligram (mg) tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 of period 1. After a washout period of 5 to 9 days participants will receive matching placebo from Day 1 to Day 5 of period 2. |
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| Placebo then JNJ-42847922 | Experimental | Participants will receive matching placebo from Day 1 to Day 5 of period 1. After a washout period of 5 to 9 days participants will receive 2*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 of period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-42847922 | Drug | Participants in arm JNJ-42847922 then Placebo will receive 2*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 in Period 1 and participants in arm Placebo then JNJ-42847922 will receive 2*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 in Period 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency by Polysomnography | The total sleep time divided by the total time in bed (that is, the number of minutes from the beginning of the Polysomnography recording to the end of the recording). | up to Night 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time by Polysomnography | All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time. | up to Night 5 |
| Wake Time After Sleep Onset by Polysomnography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hollywood | Florida | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29848147 | Derived | De Boer P, Drevets WC, Rofael H, van der Ark P, Kent JM, Kezic I, Parapatics S, Dorffner G, van Gerven J, Benes H, Keicher C, Jahn H, Seiden DJ, Luthringer R. A randomized Phase 2 study to evaluate the orexin-2 receptor antagonist seltorexant in individuals with insomnia without psychiatric comorbidity. J Psychopharmacol. 2018 Jun;32(6):668-677. doi: 10.1177/0269881118773745. Epub 2018 May 31. |
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| Placebo | Drug | Participants in arm JNJ-42847922 then Placebo will receive matching Placebo orally once daily from Day 1 to Day 5 in Period 2 and participants in arm Placebo then JNJ-42847922 will receive matching placebo orally once daily from Day 1 to Day 5 in Period 1. |
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The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording. |
| up to Night 5 |
| Number of Awakenings After Persistent Sleep by Polysomnography | Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted. | up to Night 5 |
| Total Time Spent in Deep Sleep by Polysomnography | Duration of slow wave sleep will be reported. | up to Night 5 |
| Mean Latency to Persistent Sleep by Polysomnography | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep will be measured over 2 nights and the average time to sleep will be calculated. | up to Night 5 |
| Leeds Sleep Evaluation Questionnaire (LSEQ) Score | The LSEQ is a participant-reported 10-item visual analogue scale score used to rate the quality of sleep and to assess changes in sleep quality over the course of treatment. | up to Night 5 |
| Subjective assessment of sleep by Questionnaire | Subjective assessment of sleep parameters will be assessed by following questions to indicate how much and how well participant slept during the past night: 1. How long did it take you to fall asleep for the first time (Mean Subjective sleep onset latency); 2. How long have you slept in total (Total sleep time); 3. How long were you awake after initial sleep onset until you finally got out of bed (Wake After Sleep Onset); 4. How often did you awake during the night (how many times); 5. How did you rate the quality of the night sleep (1= extremely bad 10 =excellent). | up to Night 5 |
| Next Morning Residual Effects by Bond and Lader Visual Analogue Scale | The Bond and Lader Visual Analogue Scale consists of sixteen 100 mm visual analog scales anchored by antonyms (example, Alert-Drowsy, Lethargic-Energetic, etc). Scores will be combined to form three mood factors: alertness, calmness, and contentedness. | up to Night 5 |
| Next Morning Residual Effects by cognitive test battery | up to Night 5 |
| Next Morning Residual Effects by Karolinska Sleepiness Scale | The KSS is a participant-reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from 'extremely alert' (1) to 'very sleepy, great effort to keep awake, fighting sleep (9). | up to Night 5 |
| Number of Participants with Adverse Events (AEs) and Serious AEs | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | up to Night 5 |
| Berlin |
| Germany |
| Hamburg | Germany |
| Schwerin | Germany |
| Leiden | Netherlands |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000655226 | seltorexant |
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