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Tests treatment safety and results for Treatment Resistant Depression
Official title Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression
ClinicalTrials.gov ID: NCT06278779
What this study is testing
What is Esketamine group?
Esketamine group is an investigational medicine, given as an once-weekly, being studied as a potential treatment for treatment resistant depression.
Also referred to as Spravato®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult with treatment-resistant depression (TRD: not responded adequately to at least two different antidepressants of adequate dose and duration) who...
- 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
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Camperdown, New South Wales, Australia
- Randwick, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Warners Bay, New South Wales, Australia
- Southport, Queensland, Australia
- Melbourne, Victoria, Australia
- Parkville, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Camperdown, New South Wales, Australia; Randwick, New South Wales, Australia; St Leonards, New South Wales, Australia; Warners Bay, New South Wales, Australia; Southport, Queensland, Australia; Melbourne, Victoria, Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.