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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002633-28 | EudraCT Number | ||
| 42847922MDD1009 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to explore if the magnitude of treatment effect (JNJ-42847922; placebo) on symptoms of depression (as measured by Hamilton rating scale for depression-17 [HDRS17], Sleep item-adjusted HDRS17, Anxiety/somatization factor score and the 6-item subscale from HDRS17 [HAM-D6]) differs across different levels of hyper-arousal status (characterized by Sleep parameters, ruminative response scale [RRS], Sleep and Worry visual analogue scale [VAS], quantitative electro-encephalography [qEEG], heart rate variability [HRV] and others).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lead-in period: Placebo | Placebo Comparator | Participants who successfully complete the baseline examination visit at the clinical site/unit, will be treated with placebo (2 capsules taken orally) for the duration of the lead-in period which will last up to 3 weeks. Investigators and participants will be blinded to exact duration of each participant-specific lead-in period throughout the study. |
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| Treatment period: JNJ-42847922 or Placebo | Experimental | Placebo lead-in period responders and non-responders will be randomized to receive either placebo or 20 milligram (mg) JNJ-42847922 or 40 mg JNJ-42847922 for 5 Weeks. Participants will swallow JNJ-42847922 20 mg (2*10-mg capsules) or JNJ-42847922 40 mg (2*20-mg capsules) or 2 matching placebo capsules once daily for 5 Weeks. |
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| Withdrawal period: Placebo | Placebo Comparator | Participants who will complete the treatment period prior to the end of Week 8 will enter the withdrawal period where they will be treated with placebo (2 capsules taken orally) for the remaining time of the double-blind phase of the study. Investigators and participants will be blinded to exact duration of each participant-specific withdrawal period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-42847922 20mg | Drug | Participants will swallow 20 mg (2*10 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hamilton Rating Scale for Depression-17 (HDRS17) Total Score | The HDRS17 is a Clinician-Administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a total score range of 0 to 52. It is the most widely used symptom severity measure for depression. 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 uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Total score will be calculated by summing up the individual item score. The higher the score, the more severe the depression. | Baseline up to Day 57 |
| Change From Baseline in Hamilton Rating Scale for Depression-17 (HDRS17) Sleep Item-Adjusted Total Score | The HDRS17 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. It is the most widely used symptom severity measure for depression. 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 uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. HDRS17 Sleep Item-Adjusted is derived from the HDRS17 scale excluding the 3 sleep items (4, 5, and 6) from the total score. | Baseline up to Day 57 |
| Change From Baseline in Hamilton Rating Scale for Depression-17 (HDRS17) Anxiety/Somatization Factor Score | The HDRS17 anxiety/somatization factor derived from Cleary and Guy's factor analysis of the HDRS scale, includes six items from the original 17-item version: the items for psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. Anxious depression is often defined as Major Depressive Disorder (MDD) with high levels of anxiety symptoms, as reflected in an anxiety/ somatization factor score greater than or equal to (>=) 7. The score ranges from 0 to 18, with higher scores indicating greater severity of symptoms. | Baseline up to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) | The QIDS-SR16 is a patient reported measure designed to assess the severity of depressive symptoms. The total score ranges from 0 to 27. Using a scale of severity of depression of none, mild, moderate, severe, and very severe, corresponding QIDS-SR16 total scores are none 1 to 5, mild 6 to 10, moderate 11 to 15, severe 16 to 20 and very severe 21 to 27. |
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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 |
|---|---|---|---|---|---|---|
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States | ||
| Artemis Institute for Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39663378 | Derived | Mesens S, Kezic I, Van Der Ark P, Etropolski M, Pandina G, Benes H, Savitz A, Drevets WC. Treatment effect and safety of seltorexant as monotherapy for patients with major depressive disorder: a randomized, placebo-controlled clinical trial. Mol Psychiatry. 2025 Jun;30(6):2427-2435. doi: 10.1038/s41380-024-02846-5. Epub 2024 Dec 11. |
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| JNJ-42847922 40mg | Drug | Participants will swallow 40 mg (2*20 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period. |
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| Placebo | Drug | All participants will receive matching placebo capsule during lead in period, treatment period and withdrawal period. |
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| Change From Baseline in 6 Item Subscale From HDRS17 (HAM-D6) Score | The 6-Item Hamilton Depression Scale (HAMD-6), derived by the sum of HAMD-17 items (the six items in the HAM-D6 are: depressed mood, guilt feelings, work and interests, psychomotor retardation, psychic anxiety, and general somatics [tiredness and pains]), evaluates "core" symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe). The higher the score, the more severe the depression. | Baseline up to Day 57 |
| Baseline up to Day 67 |
| Association Between Major Depressive Disorder (MDD) Symptoms and Signals of Hyper-Arousal | Association between major depressive disorder (MDD) symptoms and signals of hyper-arousal (as measured by electro-encephalography [EEG], polysomnography, and/or measures of autonomic arousal - heart rate variability) will be assessed by means of correlation analysis and mixed effect models. | Baseline up to Day 67 |
| Performance Score on a Cognitive Test Battery Evaluated by Symbol Digit Matching Test (SDMaT) | The SDMaT measures the time to pair abstract symbols with specific numbers. The test includes a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. Following the key, the participant is presented with randomly ordered symbols and is required to respond orally by naming the number or enter the number corresponding to each symbol as fast as possible using a keypad. The number of correct substitutions within 90 seconds is recorded by computerized cognitive test battery. | Baseline |
| Performance Score on a Cognitive Test Battery Evaluated by Word List Recall Test (WLRT) | The WLRT used for the computerized test battery that measures person's ability to encode, consolidate, store, and retrieve verbal information and is a sensitive test of verbal learning and memory in a variety of disease states, including MDD. The memory test will include a list of 15 words presented aloud, one at a time, through the iPad. After the 15-word list is presented, the participant will be asked to verbally recall as many of the words as possible. The 15 word list and participant recall will be conducted 4 more times (total 5 times). After the 5th learning trial and recall, performance on the learning trials of the original word list and on the delayed recall will be considered as the primary scores. The computer tablet will record and score the participant's responses to the evaluation. | Baseline |
| Performance Score on a Cognitive Test Battery Evaluated by Trail Making Test Form B (TMT-B) | The computerized (Revere.D) version of the TMT-B is modeled after the paper-and-pencil version of the test. The TMT-B measures divided attention and executive function (tracking and sequencing). The participant is instructed to draw a line to connect a set of 25 consecutively numbered and lettered circles, alternating sequentially between numbers and letters (that is, 1 A 2 B). The participant is instructed to work as quickly as possible while still maintaining accuracy. The TMT-B has acceptable reliability; reliability coefficients have typically been reported as exceeding 0.65. The TMT-B is sensitive to cognitive decline associated with MDD. | Baseline |
| Change From Baseline in Bond & Lader (B&L) Visual Analogue Scale (VAS) | The B&L VAS is made up of 16 pairs of alternative descriptors of mood and attention at either end. The Bond-Lader of a 10 cm line. Participants will rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item is scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria are then calculated from the combined scores of selected items. The score ranges from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria. | Baseline up to Day 57 |
| Change From Baseline in Profile of Mood States (POMS) | The POMS measures individuals' mood states. The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument. | Baseline up to Day 57 |
| Plasma Concentration of JNJ- 42847922 and its Metabolites | Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of JNJ-42847922 and its metabolites. | Day 36 to 40 (over 48 hours during Visit 6) |
| Percent Change From Baseline in Biomarker Levels | Percent change from baseline in biomarker includes high-sensitivity (hs) C-reactive protein (CRP), interleukin(IL) 6, IL10, IL1b, tumor necrosis factor (TNF) alpha, cortisol, growth hormone, adiponectin, leptin, brain-derived neurotrophic factor (BDNF), Insulin-like growth factor 1 (IGF1), interleukin-6 receptor (IL6R), insulin, glucose, adrenocorticotropic hormone, Kynurenine metabolites will be assessed. | Day 36 to 40 (over 48 hours during Visit 6) |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to end of the study (Day 67) |
| San Marcos |
| California |
| 92078 |
| United States |
| Qps-Mra, Llc | Miami | Florida | 33143 | United States |
| SGS Phase 1 Unit AZ St-Maarten | Mechelen | 2800 | Belgium |
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
| Charite Research Organisation GmbH | Berlin | 10117 | Germany |
| Emovis GmbH | Berlin | 10629 | Germany |
| Fraunhofer-Institut für Toxikologie und Experimentelle Medizin | Hanover | 30625 | Germany |
| Somni Bene GmbH | Schwerin | 19053 | Germany |
| Centre for Human Drug Research | Leiden | 2333 CL | Netherlands |
| MAC Clinical Research | Blackpool | FY2 0JH | United Kingdom |
| MAC Clinical Research | Liverpool | L34 1BH | United Kingdom |
| Hammersmith Medicines Research | London | NW10 7EW | United Kingdom |
| MAC Clinical Research | Manchester | M13 9NQ | United Kingdom |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000655226 | seltorexant |
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