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JNJ-61393215

Phase 2

Major Depressive Disorder With Anxious Distress | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Apr 29, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment222
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04080752A Study of JNJ-61393215 in the Treatment of DepressionPHASE2 COMPLETED 222Sep 17, 2019Sep 2, 2021Apr 29, 202535 United States, Moldova +3
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Study Endpoints
Primary Endpoints
Change From Baseline in Hamilton Depression Rating Scale-17 (HDRS-17) Total Score at Week 6
Baseline and Week 6

Change from baseline in HDRS-17 total score at Week 6 was reported. The HDRS-17 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. 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 used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).

Secondary Endpoints
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 6
Baseline and Week 6
Change From Baseline in HAM-A Total Score at Weeks 2 and 4
Baseline, Week 2, and Week 4
Change From Baseline in HDRS-17 Total Score in Participants With a Baseline HAM-A Score >=20 at Week 6
Baseline and Week 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JNJ-61393215 135 milligram (mg)EXPERIMENTALParticipants will receive JNJ-61393215 135 mg (3\*45 mg capsules) orally once daily for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study.
Interventions
NameTypeDescription
JNJ-61393215DRUGJNJ-61393215 will be administrated orally.
PlaceboDRUGMatching placebo will be administered orally.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Participants must have a body mass index (BMI) between 18 and 36 kilogram per meter square (kg/m\^2) * Participants must have a primary diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) diagnosis of major depressive disorder (MDD) with anxious distress...

Countries:United StatesMoldovaRussiaUkraineUnited Kingdom
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