Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278779
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-01-20
Brief Title:
Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression
Sponsor:
The George Institute
Organization:
The George Institute
Study Overview
Official Title:
Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-Resistant Depression a Randomised Rater-blinded Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREK
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
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
Detailed Description:
The TREK study is a randomized prospective rater blinded primary outcome raters parallel group comparative effectiveness trial of racemic ketamine and Spravato comparing their effectiveness acceptability safety effects on quality of life QOL function and cost effectiveness after 4 weeks - 6 months of treatment in people with TRD
Participants will be recruited from clinicshospitals that are providing racemic ketamine and Spravato treatment services for TRD Participants will be referred treated and followed up as per the clinics 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
Participants will be recruited from clinicshospitals that are providing racemic ketamine and Spravato treatment services for TRD Participants will be referred treated and followed up as per the clinics 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None