Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression
NCT ID: NCT06278779
Last Updated: 2025-06-03
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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RECRUITING
PHASE4
162 participants
INTERVENTIONAL
2024-06-03
2027-04-30
Brief Summary
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* How the two formulations compare in terms of their effectiveness in treating TRD.
* How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness.
Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes.
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Detailed Description
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Participants will be recruited from clinics/hospitals that are providing racemic ketamine and Spravato® treatment services for TRD. Participants will be referred, treated and followed up as per the clinic's normal clinical practice. Participants who consent to participate in this research study will undergo other processes in addition to the standard treatment procedures provided by their clinic:
* Randomisation to receive racemic ketamine or Spravato®.
* Completion of questionnaires to measure treatment effects on mood, acceptability, safety, quality of life and function and cost effectiveness.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Esketamine group
Dosing of esketamine intranasal spray will be guided by the Spravato® Product Information. This involves a starting dosage of 28 or 56 mg, with dose adjustment up to 84 mg as required to optimise response. Dose adjustments will be based on effectiveness and tolerability to the previous dose. The recommended treatment protocol is twice per week for 4 weeks, then weekly in weeks 5-8, then option of weekly-fortnightly "maintenance" treatment for responders. After week 8, patients may continue treatment as guided by the ketamine clinic psychiatrist.
Esketamine group
The recommended dosing for Spravato is:
Weeks 1-4:
Starting Day 1 dose:
\< 65 years: 56 mg
≥ 65 years: 28 mg
Subsequent doses:
28 mg (≥ 65 years), 56 mg or 84 mg twice weekly
Weeks 5-8:
28 mg (≥ 65 years), 56 mg or 84 mg once weekly
From Week 9:
28 mg (≥ 65 years), 56 mg or 84 mg every 2 weeks or once weekly
Racemic ketamine
Treatment administration will follow standard clinical practice in the recruiting clinic, with a recommendation to follow an evidence-based and established dose-optimising approach, given by injection, twice per week for 4 weeks, then the frequency of further treatments (week 5 - month 6) will be based on the clinical judgement of the ketamine clinic psychiatrist.
Dosing will be adjusted by the ketamine clinic psychiatrist, based on clinical response, safety and tolerability. The psychiatrist will review the patient before each treatment, over the first 4 weeks, to judge the dose level required.
Typically, dosing will begin at the standard dose of 0.5 mg/kg and adjusted using an ascending dose titration schedule if the patient has not shown clinical response and if side effects are adequately tolerated.
.
Racemic ketamine
Typically, dosing will begin at the standard dose of 0.5 mg/kg and adjusted as needed using an ascending dose titration schedule:
1. 0.5 mg/kg
2. 0.6 mg/kg
3. 0.75 mg/kg
4. 0.9 mg/kg
5. Further increments by 0.1-0.2 mg/kg, up to max 1.5 mg/kg
Interventions
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Esketamine group
The recommended dosing for Spravato is:
Weeks 1-4:
Starting Day 1 dose:
\< 65 years: 56 mg
≥ 65 years: 28 mg
Subsequent doses:
28 mg (≥ 65 years), 56 mg or 84 mg twice weekly
Weeks 5-8:
28 mg (≥ 65 years), 56 mg or 84 mg once weekly
From Week 9:
28 mg (≥ 65 years), 56 mg or 84 mg every 2 weeks or once weekly
Racemic ketamine
Typically, dosing will begin at the standard dose of 0.5 mg/kg and adjusted as needed using an ascending dose titration schedule:
1. 0.5 mg/kg
2. 0.6 mg/kg
3. 0.75 mg/kg
4. 0.9 mg/kg
5. Further increments by 0.1-0.2 mg/kg, up to max 1.5 mg/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Assessed and attested by clinic psychiatrist as appropriate to receive either racemic ketamine or Spravato® ketamine treatment for TRD
* Aged ≥18 years
* Written informed consent for research study obtained
Exclusion Criteria
* Any physical or mental condition which, in the opinion of the investigator, could interfere with study participation including outcome assessments
* Patients who require an interpreter/translator for the clinic consent process, due to the infeasibility of obtaining an interpreter for research assessments, including self-rated scales
18 Years
ALL
No
Sponsors
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The University of New South Wales
OTHER
The George Institute
OTHER
Responsible Party
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Principal Investigators
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Colleen Loo
Role: PRINCIPAL_INVESTIGATOR
The University of New South Wales
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Black Dog Institute
Randwick, New South Wales, Australia
Ramsay Clinic Northside
St Leonards, New South Wales, Australia
Ramsay Clinic Lakeside
Warners Bay, New South Wales, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Ramsay Clinic Albert Road
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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X23-0311
Identifier Type: -
Identifier Source: org_study_id
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