Depressive Disorder, MajorPhase 1NCT03374475
A Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Participants With Major Depressive Disorder
A Phase 1 study testing JNJ-42847922 20mg and JNJ-42847922 40mg in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 14 sites in 5 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- JNJ-42847922 20mg and JNJ-42847922 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 5 Jan 2018to 29 Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m^2) inclusive (BMI = weight/height^2)
- Participants must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
- Population specific: Participant must meet Diagnostic and Statistical Manual of Mental Disorders - fifth edition (DSM-5) diagnostic criteria for MDD (international classification of diseases [ICD]-code F32.x and F33.x), without psychotic features, and confirmed by the Mini International Neuropsychiatric Interview (MINI) 7.0; have a Montgomery Asberg Depression Rating Scale (MADRS) total score greater than or equal to (>=) 25 at screening and must not demonstrate a clinically significant change (that is, an improvement of greater than (>) 20 percent (%) on their MADRS total score) from the screening to the second completion of MADRS by telephone at most 4 days before the baseline visit; Not currently receiving antidepressant drug therapy for >= 2 weeks before screening
- Men who are sexually active with a women of childbearing potential (WOCBP) and have not had a vasectomy must agree to use a barrier method of birth control
- A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after receiving the last dose of study drug
Who cannot join
- Has failed more than 2 treatments (no more than 20 percent (%) response) with a differing pharmacological mode of action despite an adequate dose and duration during a previous, or the current depressive episode
- Has a diagnosis of Cushing's Disease, Addison's Disease, primary amenorrhea, or other evidence of significant medical disorders of the Hypothalamus pituitary adrenal (HPA) axis
- Is pregnant or breast feeding
- Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the planned first dose of study drug, or has participated in 2 or more interventional clinical studies in the previous 1 year, or is currently enrolled in an interventional study
- Participant is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
- Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Germany4 sites
Charite Research Organisation GmbH
Berlin, 10117
Emovis GmbH
Berlin, 10629
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin
Hanover, 30625
Somni Bene GmbH
Schwerin, 19053
United Kingdom4 sites
MAC Clinical Research
Blackpool, FY2 0JH
MAC Clinical Research
Liverpool, L34 1BH
Hammersmith Medicines Research
London, NW10 7EW
MAC Clinical Research
Manchester, M13 9NQ
United States3 sites
Qps-Mra, Llc
Miami, Florida, 33143
Artemis Institute for Clinical Research
San Diego, California, 92103
Artemis Institute for Clinical Research
San Marcos, California, 92078
Belgium2 sites
SGS Phase 1 Unit AZ St-Maarten
Mechelen, 2800
Clinical Pharmacology Unit
Merksem, 2170
About this study
Official title: An Exploratory, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Subjects With Major Depressive Disorder
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).
- Conditions
- Depressive Disorder, Major
- Being tested
- JNJ-42847922 20mg, JNJ-42847922 40mg, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42847922 20mgDrug
Participants will swallow 20 mg (2*10 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.
JNJ-42847922 40mgDrug
Participants will swallow 40 mg (2*20 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.
PlaceboDrug
All participants will receive matching placebo capsule during lead in period, treatment period and withdrawal period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Placebo |
| 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. Receives: Drug: JNJ-42847922 20mg; Drug: JNJ-42847922 40mg; Drug: Placebo |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Day 57
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.
Measured: Baseline up to Day 57
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to end of the study (Day 67)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start5 Jan 2018
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374475
- Sponsor's protocol ID
- CR108382
- Other IDs
- 2017-002633-28, 42847922MDD1009, 2017
- Status last verified
- Apr 2025
- First submitted
- 4 Dec 2017
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 39663378
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Subjects With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03374475
- Acronym / sponsor ID
- CR108382
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lead-in period: Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
| Treatment period: JNJ-42847922 or Placebo | Experimental | Drug: JNJ-42847922 20mg, Drug: JNJ-42847922 40mg, Drug: PlaceboPlacebo 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. |
| Withdrawal period: Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Have a body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m^2) inclusive (BMI = weight/height^2)
- Participants must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline
- Population specific: Participant must meet Diagnostic and Statistical Manual of Mental Disorders - fifth edition (DSM-5) diagnostic criteria for MDD (international classification of diseases [ICD]-code F32.x and F33.x), without psychotic features, and confirmed by the Mini International Neuropsychiatric Interview (MINI) 7.0; have a Montgomery Asberg Depression Rating Scale (MADRS) total score greater than or equal to (>=) 25 at screening and must not demonstrate a clinically significant change (that is, an improvement of greater than (>) 20 percent (%) on their MADRS total score) from the screening to the second completion of MADRS by telephone at most 4 days before the baseline visit; Not currently receiving antidepressant drug therapy for >= 2 weeks before screening
- Men who are sexually active with a women of childbearing potential (WOCBP) and have not had a vasectomy must agree to use a barrier method of birth control
- A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose
Key exclusion criteria (6 listed)
- Has failed more than 2 treatments (no more than 20 percent (%) response) with a differing pharmacological mode of action despite an adequate dose and duration during a previous, or the current depressive episode
- Has a diagnosis of Cushing's Disease, Addison's Disease, primary amenorrhea, or other evidence of significant medical disorders of the Hypothalamus pituitary adrenal (HPA) axis
- Is pregnant or breast feeding
- Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 60 days before the planned first dose of study drug, or has participated in 2 or more interventional clinical studies in the previous 1 year, or is currently enrolled in an interventional study
- Participant is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-42847922 20mgParticipants will swallow 20 mg (2*10 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period. | Drug | Treatment period: JNJ-42847922 or Placebo |
| JNJ-42847922 40mgParticipants will swallow 40 mg (2*20 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period. | Drug | Treatment period: JNJ-42847922 or Placebo |
| PlaceboAll participants will receive matching placebo capsule during lead in period, treatment period and withdrawal period. | Drug | Lead-in period: Placebo, Treatment period: JNJ-42847922 or Placebo, Withdrawal period: Placebo |
Primary outcome
Change From Baseline in Hamilton Rating Scale for Depression-17 (HDRS17) Total Score
Time frame: Baseline up to Day 57
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.
Change From Baseline in Hamilton Rating Scale for Depression-17 (HDRS17) Sleep Item-Adjusted Total Score
Time frame: Baseline up to Day 57
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.
Change From Baseline in Hamilton Rating Scale for Depression-17 (HDRS17) Anxiety/Somatization Factor Score
Time frame: Baseline up to Day 57
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.
Change From Baseline in 6 Item Subscale From HDRS17 (HAM-D6) Score
Time frame: Baseline up to Day 57
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.
10 secondary outcomes
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16)
Time frame: Baseline up to Day 67
Association Between Major Depressive Disorder (MDD) Symptoms and Signals of Hyper-Arousal
Time frame: Baseline up to Day 67
Performance Score on a Cognitive Test Battery Evaluated by Symbol Digit Matching Test (SDMaT)
Time frame: Baseline
Performance Score on a Cognitive Test Battery Evaluated by Word List Recall Test (WLRT)
Time frame: Baseline
Performance Score on a Cognitive Test Battery Evaluated by Trail Making Test Form B (TMT-B)
Time frame: Baseline
Change From Baseline in Bond & Lader (B&L) Visual Analogue Scale (VAS)
Time frame: Baseline up to Day 57
Change From Baseline in Profile of Mood States (POMS)
Time frame: Baseline up to Day 57
Plasma Concentration of JNJ- 42847922 and its Metabolites
Time frame: Day 36 to 40 (over 48 hours during Visit 6)
Percent Change From Baseline in Biomarker Levels
Time frame: Day 36 to 40 (over 48 hours during Visit 6)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to end of the study (Day 67)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 39663378Mesens 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-42847922 20mg and JNJ-42847922 40mg in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, United Kingdom, United States, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hamilton Rating Scale for Depression-17 (HDRS17) Total Score (time frame: Baseline up to Day 57). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03374475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.