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| ID | Type | Description | Link |
|---|---|---|---|
| 54175446MDD1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2016-001929-14 | EudraCT Number |
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The primary purpose of this study is to investigate the safety and tolerability of JNJ 54175446 in participants with Major Depressive Disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: JNJ-54175446 | Experimental | Participants will receive a loading dose of JNJ-54175446, 600 milligram (mg) on Day 1 followed by JNJ-54175446, 150 mg once daily until Day 10. |
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| Group B: Placebo + JNJ-54175446 | Experimental | Participants will receive placebo on Days 1 to 3 followed by a loading dose of JNJ-54175446, 600 mg on Day 4 followed by JNJ-54175446, 150 mg once daily until Day 10. |
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| Group C: Placebo | Placebo Comparator | Participants will receive placebo from Day 1 until Day 10. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-54175446, 600 mg | Drug | Participants will receive JNJ-54175446, 600 mg as an oral suspension. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of JNJ-54175446 Versus Placebo on Total Sleep Deprivation (TSD)-Induced Changes in Depressive Symptoms by HDRS17/IDS-C30 Rating Scale | Hamilton Depression Rating Scale 17 (HDRS17) contains 17 items pertaining to symptoms of depression experienced over the past week. Score range is from 0 to 52. The Inventory of Depressive Symptomatology- Clinician rated-30 (IDS-C30) is a standardized 30 item, clinician rated, scale to assess the severity of a participant's depressive symptoms. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. |
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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 |
|---|---|---|---|---|---|---|
| Berlin | Germany | |||||
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| JNJ-54175446, 150 mg | Drug | Participants will receive JNJ-54175446, 150 mg as an oral suspension. |
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| Placebo | Other | Matching placebo to JNJ-54175446 |
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| Baseline, Day 4 and 10: 2 to 8 hours post dose, Day 17 |
| Effect of JNJ-54175446 Versus Placebo on Total Sleep Deprivation (TSD)-Induced Changes in Depressive Symptoms by QIDS-SR16/QIDS-SR10 Rating Scale | The QIDS-SR16 (1 week recall period) is a participant reported measure designed to assess the severity of depressive symptoms. The total score ranges from 0 to 27 (none 1-5, mild 6-10, moderate 11-15, severe 16-20 and very severe 21-27). QIDS-SR10 is a version of the QIDS-SR16 with a shorter, 2-hour recall period and 10-item measure. Scoring for each domain will be the same as for the QIDS-SR16. | Baseline, Day 3 and 10: 2 to 8 hours post dose, Day 17 |
| Effect of JNJ-54175446 Versus Placebo on TSD-Induced Changes in Biomarker Profiles (interleukin [IL]-1 beta, cortisol) | Day 1 and 4: Predose, 2, 8 hours postdose, Day 10: Predose |
| Effect of JNJ-54175446 Versus Placebo on Latency to Persistent Sleep (LPS) | Latency to persistent sleep is defined as the length of time from full wakefulness to the first sleep stage. | Baseline, Day 2 to 3 and Day 4 to 5 |
| Effect of JNJ-54175446 Versus Placebo on Total Sleep Time (TST) | 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. | Baseline, Day 2 to 3 and Day 4 to 5 |
| Effect of JNJ-54175446 Versus Placebo on Wake After Sleep Onset (WASO) | The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording. | Baseline, Day 2 to 3 and Day 4 to 5 |
| Effect of JNJ-54175446 Versus Placebo on Sleep Efficiency (SE) | 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). | Baseline, Day 2 to 3 and Day 4 to 5 |
| Effect of JNJ-54175446 Versus Placebo on Snaith-Hamilton Pleasure Scale [SHAPS]) | The SHAPS is a short, 14-item instrument to measure anhedonia, which has been shown to be valid and reliable in normal and clinical samples. Each of the 14 items has a set of four response categories: Definitely Agree (= 1), Agree (= 2), Disagree (= 3), and Definitely Disagree (= 4). A higher total score indicates higher levels of state anhedonia. | Baseline, Day 3, 4, 5 and 10: 2 to 8 hours postdose |
| Effect of JNJ-54175446 Versus Placebo on Profile of Mood States brief form (POMS) | The POMS measures individuals' mood states. The POMS consists of 30 positive and negative mood descriptors. Participants are asked to rate, on a 5-point scale from 0 (not at all) to 4 (extremely), the extent to which they experience each mood state during at a specific moment. | Baseline, Day 3, 10: 2 to 8 hours postdose, Day 4, 5: 2 to 8 and 19 hours postdose |
| Effect of JNJ-54175446 Versus Placebo on Emotional Faces Recognition Test | Evaluation of positive and negative effect using emotional faces recognition test. The participant is seated at a computer screen and instructed to remember 42 images shown during a training session. Subject then identifies those images during a testing session in which the 42 probe images are interspersed among 42 additional foil images. Implicit recognition is detected by EEG. | Baseline, Day 4 and 10: 2 to 8 hours postdose |
| Effect of JNJ-54175446 Versus Placebo on Soluble Biomarkers (Inclusive Ex-vivo Lipopolysaccharide [LPS]/Benzoylated(Bz) Adenosine Triphosphate [ATP]-Induced IL-1 Beta Release) | Day 1 and 4: Predose, 2, 8 hours postdose, Day 10: Predose |
| Effect of JNJ-54175446 Versus Placebo on Central Pharmacodynamic (PD) by Motor Learning by Adaptive Tracking Test | Performance will be scored after a fixed period of 3.5 minutes and reflected visuo motor control and vigilance. The average performance scores will be used in the analysis. | Baseline, Day 10: Predose, 1, 2, 4 and 6 hour post dose |
| Effect of JNJ-54175446 Versus Placebo on Sustained Attention by the Three Choice Vigilance Task (3CVT) With EEG | An implicit image recognition (IR) task combined with emotional elicitation evaluates attention, encoding and image recognition memory during implicit emotion elicitation. | Baseline, Day 3, 4, 5 and 10: 2 to 8 hours postdose |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-54175446 | The Cmax is the maximum observed plasma concentration. | Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17 |
| Minimum Observed Plasma Concentration (Cmin) of JNJ-54175446 | Minimum observed plasma concentration during dosing interval (tau). | Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17 |
| Trough Plasma Concentration (Ctrough) of JNJ-54175446 | The observed plasma concentration just prior to the beginning or at the end of a dosing interval of any dose other than the first dose. | Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17 |
| Average Plasma Concentration at Steady State (Cavg) of JNJ-54175446 | Average plasma concentration at steady state over the dosing interval. | Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-54175446 | Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17 |
| Area Under the Plasma ConcentrationTime Curve During a Dosing Interval (tau) [AUCtau] of JNJ-54175446 | Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17 |
| Area Under the Plasma ConcentrationTime Curve From Time Zero to Time 't' (AUC[0t]) of JNJ-54175446 | Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17 |
| Apparent Elimination HalfLife (t1/2) of JNJ-54175446 | Apparent elimination half-life associated with the terminal slope (Lambda[z]) of the semilogarithmic drug concentration time curve, after multiple-dose administration only. | Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17 |
| Ratio of the Maximum Plasma Concentration (Peak) to Trough Observed Concentration of JNJ-54175446 | The ratio of the maximum plasma concentration (Peak) to trough observed concentration. | Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17 |
| Accumulation Ratio Based on AUC of JNJ-54175446 | Accumulation ratio based on AUC, determined after multiple-dose administration and calculated as AUCtau on Day 1 divided by AUCtau on Day 10. | Day 1: Predose, 1, 2, 4, 8, 10 hour postdose; Day 2 and 3: Predose; Day 4: Predose, 2, 4, 8 hour postdose; Day 5 and 7: Predose; Day 10: Predose, 1, 2, 4, 8, 10, 24, 48 hour postdose; Day 17 |
| Effect of JNJ-54175446 Versus Placebo on a Reward Test | The reward task was a probabilistic instrumental learning task involving monetary wins or losses. In order to maximize payoffs, participants should use the outcome feedback to gradually learn the symbol-outcome associations by trial and error over time, such that they consistently choose the symbol with the high-probability win and avoid the symbol with the high-probability loss. Outcome measures included overall total, total won and lost, choice frequency, percentage of choices identical to the preceding one (percentage consistency), reaction time and re-reaction time. | Baseline, Day 3, 4, 5 and 10: 2 to 8 hours postdose |
| Hamburg |
| Germany |
| Schwerin | Germany |
| Leiden | Netherlands |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000655225 | JNJ-54175446 |
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