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Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression (TRD)

NCT03829579 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2025-06-22

No results posted yet for this study

Summary

This is a pre-approval access program (PAAP) for eligible participants. The main purpose of this program is to provide access to esketamine nasal spray to eligible participant with treatment-resistant depression (TRD), who have exhausted all other treatment options, including all alternative treatment options with marketed therapies.

Conditions

  • Depressive Disorder, Treatment-Resistant

Interventions

DRUG

Esketamine

Participants will self-administer esketamine nasal spray, under the supervision of the healthcare professional at the site of care. A starting dose of 56 milligram (mg) will be administered intranasally into each nostril on Day 1 with subsequent doses of 56 mg or 84 mg administered during Weeks 1-4 (2 treatment sessions per week). For participants who respond, treatment is continued as follows: 56 mg or 84 mg of esketamine nasal spray during Weeks 5-8 (once weekly), and Week 9 onwards (every 2 weeks or once weekly), with period re-evaluation to determine the need for continued treatment. Doses will be adjusted based on efficacy and tolerability to the previous dosing.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03829579 on ClinicalTrials.gov