A Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Participants With Major Depressive Disorder
NCT ID: NCT03374475
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
140 participants
INTERVENTIONAL
2018-01-05
2019-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lead-in period: Placebo
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.
Placebo
All participants will receive matching placebo capsule during lead in period, treatment period and withdrawal period.
Treatment period: JNJ-42847922 or Placebo
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.
JNJ-42847922 20mg
Participants will swallow 20 mg (2\*10 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.
JNJ-42847922 40mg
Participants will swallow 40 mg (2\*20 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.
Placebo
All participants will receive matching placebo capsule during lead in period, treatment period and withdrawal period.
Withdrawal period: Placebo
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.
Placebo
All participants will receive matching placebo capsule during lead in period, treatment period and withdrawal period.
Interventions
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JNJ-42847922 20mg
Participants will swallow 20 mg (2\*10 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.
JNJ-42847922 40mg
Participants will swallow 40 mg (2\*20 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.
Placebo
All participants will receive matching placebo capsule during lead in period, treatment period and withdrawal period.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Artemis Institute for Clinical Research
San Diego, California, United States
Artemis Institute for Clinical Research
San Marcos, California, United States
Qps-Mra, Llc
Miami, Florida, United States
SGS Phase 1 Unit AZ St-Maarten
Mechelen, , Belgium
Clinical Pharmacology Unit
Merksem, , Belgium
Charite Research Organisation GmbH
Berlin, , Germany
Emovis GmbH
Berlin, , Germany
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin
Hanover, , Germany
Somni Bene GmbH
Schwerin, , Germany
Centre for Human Drug Research
Leiden, , Netherlands
MAC Clinical Research
Blackpool, , United Kingdom
MAC Clinical Research
Liverpool, , United Kingdom
Hammersmith Medicines Research
London, , United Kingdom
MAC Clinical Research
Manchester, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2017-002633-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
42847922MDD1009
Identifier Type: OTHER
Identifier Source: secondary_id
CR108382
Identifier Type: -
Identifier Source: org_study_id
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