Clinical trial NCT06278779: Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression
Official title: Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-Resistant Depression: a Randomised, Rater-blinded Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Treatment Resistant Depression
Lead sponsor: The George Institute
Sponsor class: OTHER
Collaborators: name: The University of New South Wales
First posted: 2024-02-26
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, prospective, parallel group, comparative effectiveness trial.
Primary purpose: TREATMENT

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.

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 clinics/hospitals that are providing racemic ketamine and Spravato® treatment services for TRD. Participants will be referred, treated and followed up as per the clinic's 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.

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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: From week 0 to week 4.
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS) score
timeFrame: At week 8, month 4 and month 6
measure: Response - Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Weeks 4, 8 and months 4 and 6
measure: Remission - Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Weeks 4, 8 and months 4 and 6
measure: DASS-21
timeFrame: Performed weekly from baseline to week 8 inclusive and at 6 month visit.
measure: Clinical Global Impression-Improvement (CGI-I)
timeFrame: Performed weekly from week 1 to week 4 inclusive, then at week 8 and at 6 month visits.
measure: Clinical Global Impression-Severity (CGI-S)
timeFrame: Performed weekly from baseline to week 4 inclusive, then at week 8 and at 6 month visits.
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Performed weekly from baseline to week 4 inclusive, then at week 8 and at 6 month visits.
measure: Speed of response - Clinical Global Impression-Improvement (CGI-I)
timeFrame: Performed weekly from week 1 to week 4 inclusive, then at week 8 and at 6 month visits.
measure: Psychotomimetic symptoms
timeFrame: Through study completion at each treatment visit, up to 6 months
measure: Suicide attempts or gestures
timeFrame: During 6-month study period
measure: Number of Participants with urinary symptoms, as assessed using the Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)
timeFrame: Performed at baseline, week 4, week 8 and at 6 month visit.
measure: Cognitive Failure Questionnaire scores (CFQ)
timeFrame: Performed at baseline, week 4, week 8 and at 6 month visit.
measure: Ketamine liking/craving score
timeFrame: Performed at baseline, week 4, week 8 and at 6 month visit.
measure: Number of Participants with urinary symptoms, as assessed using the Ketamine Side Effect Tool (KSET)
timeFrame: Through study completion at each treatment visit, up to 6 months
measure: Acceptability Questionnaire
timeFrame: Performed at week 4, week 8 and at 6 month visit.
measure: End of Treatment questionnaire
timeFrame: Used at end of the treatment period(s) over the course of the study.
measure: Recovering Quality of Life Questionnaire (REQOL-10)
timeFrame: Over 6 month study period
measure: WHO Disability Assessment Scale (WHODAS-12)
timeFrame: Over 6 month study period
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Over 6 month study period
measure: Assessment of Quality of Life Questionnaire (AQoL-8D)
timeFrame: Over 6 month study period
measure: Resource Use Questionnaire (RUQ)
timeFrame: Over 6 month study period
measure: Treatment Preference
timeFrame: Assessed once, prior to randomization
measure: Stanford Expectations of Treatment Scale (SETS)
timeFrame: Assessed once, after randomization and before first treatment
measure: Difficulties in Emotion Regulation Scale-16 (DERS-16)
timeFrame: Performed at baseline and week 4
measure: Level of Personality Functioning Scale-Brief Form (LPFS-BF)
timeFrame: Performed at baseline and week 4
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Black Dog Institute
state: New South Wales
city: St Leonards
country: Australia
facility: Ramsay Clinic Northside
state: New South Wales
city: Warners Bay
country: Australia
facility: Ramsay Clinic Lakeside
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Ramsay Clinic Albert Road
state: Victoria
Study officials:
affiliation: The University of New South Wales
name: Colleen Loo
role: PRINCIPAL_INVESTIGATOR
References: