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Esketamine Nasal Spray in Treatment-resistant Depression
NCT07716098Phase 3
Key facts
- Status
- Recruiting
- Start
- Jul 2026
- Primary completion
- Dec 2028
- Countries
- 4
- Sponsor
- Janssen Pharmaceutical
- Drugs
- esketamine
- Conditions
- treatment-resistant depression (TRD)
01
Overview
Phase 3, randomised, double-blind trial of esketamine in treatment-resistant depression (TRD) (3 arms), sponsored by Janssen Pharmaceutical. Primary endpoint: Montgomery-Asberg Depression Rating Scale Total Score at 4 weeks. Started Jul 2026; status: recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Esketamine 56 mg
Esketamine 56 mg twice a week for 4 weeks.
Esketamine 84 mg
Esketamine 84 mg twice a week for 4 weeks.
Placebo
Placebo twice a week for 4 weeks.
03
Who it enrols
Adults with treatment-resistant depression who have failed at least 2 oral antidepressants, excluding those with lifetime ketamine/esketamine use, recent substance abuse, or significant suicidal risk.
04
Endpoints
Primary
Montgomery-Asberg Depression Rating Scale Total Score
Secondary
Montgomery-Asberg Depression Rating Scale Total Score
Percentage of Responders in MADRS
Percentage of Participants in Remission in MADRS
Clinical Global Impression-Severity
MADRS Anhedonia Factor Score
Patient Health Questionnaire 9-item Item 1 Score
Patient Health Questionnaire 9-item Total Score
Percentage of Responders in PHQ-9
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