Trials Sponsors Conditions Drugs Pricing

Conditions

Major Depressive Disorder

Keywords

Depression

Outcome Measures

Primary Outcomes (3)

Percentage of treatment responders determined by a 50% reduction on the Hamilton Depression Rating Scale (HAM-D) 17-Item scoring.
Hamilton Depression Rating Scale (HAM-D) 17-Item scoring
At the end of week 4
Mean depression score on the Quick Inventory of Depressive Symptomatology Self-report (QIDS-SR) 16-Item.
Quick Inventory of Depressive Symptomatology Self-report (QIDS-SR) 16-Item.
Baseline, at the end of weeks 1,2,3, and 4 (primary time point); and further after week 8 and week 12 after Esketamine was commenced.
Global functioning determined by Clinical Global Impression (CGI) score.
Clinical Global Impression (CGI)
Baseline, week 1, week 2, week 3, week 4 (primary time point), week 8 and week 12 after Esketamine was commenced.

Secondary Outcomes (3)

Change in mood symptom scores assessed using the visual analogue scale (self-reported)
Baseline, after treatment day 1 and day 3 of each week until Esketamine is ceased.
Depressive symptoms assessed using the Beck Depression Inventory (BDI) 21-Item.
Baseline and at week 4 after Esketamine was commenced.
Anxiety symptoms assessed using the State-Trait Anxiety Inventory (STAI)
Baseline and at week 4 after Esketamine was commenced.

Study Arms (1)

Participants with Major Depressive Disorder

OTHER

Intranasal esketamine to be self-administered by participants under direct supervision of a healthcare professional. First initial dose is 56mg and subsequent doses will be 56mg or 84mg. Esketamine will be administered twice weekly for weeks 1-4, once weekly for weeks 5-8, and once weekly/once fortnightly/once monthly as clinically indicated for weeks 9-25. After each treatment phase, participants will be re-assessed through a comprehensive battery of assessments and dose adjustments will be performed by the study psychiatrist base on tolerability, treatment response, and ongoing consent.

Drug: Esketamine Nasal Spray [Spravato]

Interventions

Esketamine Nasal Spray [Spravato]Drug

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.

Also known as: Spravato

Participants with Major Depressive Disorder

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults aged 18-65 years old
Diagnosis of Major Depressive Disorder (MDD)

Sponsors & Collaborators

Janssen-Cilag Pty Ltd
Industrycollaborator
Royal North Shore Hospital
Otherlead

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

RECRUITING

Erica BellCONTACT02 9462 9905 NSLHD-researchpoet@health.nsw.gov.au

Yan Yau WongCONTACTNSLHD-researchpoet@health.nsw.gov.au

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

Gin Malhi
Royal North Shore Hospital, University of Sydney
PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Bell

CONTACT

02 9462 9905 NSLHD-researchpoet@health.nsw.gov.au

Yan Yau Wong

CONTACT

NSLHD-researchpoet@health.nsw.gov.au

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

October 15, 2023

First Posted

October 27, 2023

Study Start

October 31, 2023

Actual (reported)

Primary Completion

December 15, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (1)

Participants with Major Depressive Disorder

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (1)

Participants with Major Depressive Disorder

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations