NCT06278779 Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression
| NCT ID | NCT06278779 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The George Institute |
| Condition | Treatment Resistant Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2024-06-03 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 162 participants in total. It began in 2024-06-03 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are: * 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.
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 * MADRS score of ≥20 at study baseline, assessed by certified study rater * 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 * Any treatment with ketamine or Spravato® within 4 weeks prior to written informed consent for the research study * 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
Contact & Investigator
Colleen Loo
PRINCIPAL INVESTIGATOR
The University of New South Wales
Frequently Asked Questions
Who can join the NCT06278779 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Treatment Resistant Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06278779 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06278779 currently recruiting?
Yes, NCT06278779 is actively recruiting participants. Contact the research team at Trek@georgeinstitute.org.au for enrollment information.
Where is the NCT06278779 trial being conducted?
This trial is being conducted at Camperdown, Australia, Randwick, Australia, St Leonards, Australia, Warners Bay, Australia and 3 additional locations.
Who is sponsoring the NCT06278779 clinical trial?
NCT06278779 is sponsored by The George Institute. The principal investigator is Colleen Loo at The University of New South Wales. The trial plans to enroll 162 participants.
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