Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression
Launched by THE GEORGE INSTITUTE · Feb 19, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is comparing two types of ketamine treatments, called Spravato® and racemic ketamine, to see which one works better for people with treatment-resistant depression (TRD). TRD is when someone has not found relief from their depression despite trying at least two different antidepressant medications. The study will look at how effective these treatments are, how well patients accept them, their safety, and how they affect overall quality of life and costs.
To participate, individuals must be at least 18 years old and have a current episode of depression that hasn't improved with previous treatments. Participants will be randomly assigned to receive either Spravato® or racemic ketamine. They will fill out questionnaires to help researchers understand how the treatments impact their mood, any side effects, and their daily functioning. This study is currently looking for volunteers, and it’s important for potential participants to discuss their eligibility with their healthcare provider.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult with treatment-resistant depression (TRD: not responded adequately to at least two different antidepressants of adequate dose and duration) who has a current depressive episode (DSM 5)
- • 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:
- • Not able to give informed consent
- • 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
About The George Institute
The George Institute for Global Health is a leading research organization dedicated to improving health outcomes through innovative clinical trials and groundbreaking research. Based in Australia, the institute focuses on addressing major health challenges, particularly in the areas of chronic diseases, cardiovascular health, and health equity. With a commitment to translating scientific discoveries into real-world applications, The George Institute collaborates with global partners to advance knowledge and implement effective health interventions. Its multidisciplinary team of researchers employs rigorous methodologies to ensure high-quality evidence that informs policy and practice, ultimately striving to enhance public health on a global scale.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Camperdown, New South Wales, Australia
Parkville, Victoria, Australia
Southport, Queensland, Australia
Warners Bay, New South Wales, Australia
Melbourne, Victoria, Australia
Randwick, New South Wales, Australia
St Leonards, New South Wales, Australia
Patients applied
Trial Officials
Colleen Loo
Principal Investigator
The University of New South Wales
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported