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

NCT06103760 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2023/PID01587
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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

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

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years old
• Diagnosis of Major Depressive Disorder (MDD)
• Currently depressed
• Had an inadequate response to 2 or more courses of antidepressants (of adequate dose and duration)
• Be maintained on their current antidepressant medication or psychological therapy at the time of enmrolment
• Able to understand and provide informed consent

You may not qualify if:

• Concurrent diagnoses:
• Participants with other 'Diagnostic and Statistical Manual of Mental Disorders' (DSM-5) e.g., current substance misuse disorder, bipolar disorder, schizophrenia
• Participants who are unable to understand the study and therefore unable to provide informed consent
• Pregnancy:
• Participants who are pregnant and/or breastfeeding
• Participants who are not willing to avoid pregnancy for themselves or their partners during the study by using effective birth control methods
• Current medications:
• Participants taking a total daily dose of benzodiazepines greater than the equivalent of 6mg/day of lorazepam
• Participants on complementary and alternative medicine therapies i.e., St John's wort, Chinese medicines, and various herbal and homeopathic treatments
• Stimulants
• Participants taking stimulants such as methylphenidate, amphetamine, and dextroamphetamine for a diagnosis such as ADHD can still have Esketamine provided they do not continue taking stimulants concurrently for the duration of the study.
• Concurrent use is excluded due to the synergistic effect with Esketamine that can cause increased blood pressure.
• Medical history:
• Participants with a history of uncontrolled hypertension
• Participants with uncontrolled diabetes mellitus

Sponsors & Collaborators

• Royal North Shore Hospital: lead
• Janssen-Cilag Pty Ltd: collaborator

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

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

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
• Primary Completion: September 15, 2025
• Study Completion: January 15, 2026
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)