A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
NCT ID: NCT07227454
Last Updated: 2025-11-12
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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NOT_YET_RECRUITING
PHASE3
258 participants
INTERVENTIONAL
2025-11-20
2031-09-15
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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Intranasal Esketamine + Oral Placebo
Participants will receive intranasal esketamine 84 milligrams (mg) along with oral placebo solution twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a decrease to intranasal esketamine 56 mg (in a blinded fashion per investigator's judgment) is permitted. Thereafter, dose may be flexed between 56 mg and 84 mg during the treatment period.
Esketamine
Esketamine will be administered as intranasal solution.
Oral Placebo
Placebo will be administered as oral solution.
Intranasal Placebo + Oral Midazolam
Participants will receive oral midazolam (0.0625 milligrams per kilograms \[mg/kg\]) and intranasal placebo twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a sham decrease to esketamine 56 mg dose (in a blinded fashion per investigator's judgment) is permitted. Thereafter, sham dose may be flexed between 56 mg and 84 mg during the treatment period.
Midazolam
Midazolam will be administered as oral solution.
Intranasal Placebo
Intranasal placebo will be administered as nasal solution.
Interventions
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Esketamine
Esketamine will be administered as intranasal solution.
Midazolam
Midazolam will be administered as oral solution.
Oral Placebo
Placebo will be administered as oral solution.
Intranasal Placebo
Intranasal placebo will be administered as nasal solution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of "Markedly" or greater (that is, greater than or equal to \[\>=\] 4) at both screening and baseline (predose) visits
* Must have a children's depression rating scale - revised (CDRS-R) total score \>= 58 at baseline (predose)
* In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality
* Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
Exclusion Criteria
* Participant currently meets DSM-5 criteria for borderline personality disorder
* Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis
* Participant has a history of seizure disorder
* Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients
12 Years
17 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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54135419SUI3003
Identifier Type: OTHER
Identifier Source: secondary_id
2024-518615-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
54135419SUI3003
Identifier Type: -
Identifier Source: org_study_id