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Positioning of Esketamine Treatment in the Real-world Management of Depression

NCT06103760 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2024-05-17

No results posted yet for this study

Summary

The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are:

* to investigate whether Esketamine is effective when added to ongoing antidepressant treatment
* to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice

Participants will:

* attend the clinic for supervised self-administration of intranasal Esketamine treatment
* be observed for 2 hours following Esketamine administration including blood pressure monitoring
* be asked to complete a battery of questionnaires
* be reimbursed for travel expenses

Conditions

Interventions

DRUG

Esketamine Nasal Spray [Spravato]

This is an uncontrolled, single arm, naturalistic study. There will be three treatment phases: Phase 1 - Acute treatment phase (weeks 1-4); Phase 2 - Maintenance treatment phase (weeks 5-8); Phase 3 - Continuation treatment phase (Weeks 9-25). Phase 1 is the critical component of our study as it determines our primary outcomes.

Sponsors & Collaborators

  • Janssen-Cilag Pty Ltd

    collaborator INDUSTRY

  • Royal North Shore Hospital

    lead OTHER

Principal Investigators

  • Gin Malhi · Royal North Shore Hospital, University of Sydney

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2025-09-15
Completion
2026-01-15
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT06103760 on ClinicalTrials.gov