Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression

PHASE4RecruitingINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

June 3, 2024

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2027

Conditions
Treatment Resistant Depression
Interventions
DRUG

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"

DRUG

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"

Trial Locations (6)

2031

RECRUITING

Black Dog Institute, Randwick

2050

RECRUITING

Royal Prince Alfred Hospital, Camperdown

2065

RECRUITING

Ramsay Clinic Northside, St Leonards

2282

RECRUITING

Ramsay Clinic Lakeside, Warners Bay

3004

RECRUITING

Ramsay Clinic Albert Road, Melbourne

4215

RECRUITING

Gold Coast University Hospital, Southport

All Listed Sponsors
collaborator

The University of New South Wales

OTHER

lead

The George Institute

OTHER