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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06278779
Registration number
NCT06278779
Ethics application status
Date submitted
20/01/2024
Date registered
26/02/2024
Date last updated
16/08/2024
Titles & IDs
Public title
Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression
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Scientific title
Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-Resistant Depression: a Randomised, Rater-blinded Trial
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Secondary ID [1]
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X23-0311
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Universal Trial Number (UTN)
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Trial acronym
TREK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Treatment Resistant Depression
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Esketamine group
Treatment: Drugs - Racemic ketamine
Active comparator: Esketamine group - Dosing of esketamine intranasal spray will be guided by the Spravato® Product Information. This involves a starting dosage of 28 or 56 mg, with dose adjustment up to 84 mg as required to optimise response. Dose adjustments will be based on effectiveness and tolerability to the previous dose. The recommended treatment protocol is twice per week for 4 weeks, then weekly in weeks 5-8, then option of weekly-fortnightly "maintenance" treatment for responders. After week 8, patients may continue treatment as guided by the ketamine clinic psychiatrist.
Active comparator: Racemic ketamine - Treatment administration will follow standard clinical practice in the recruiting clinic, with a recommendation to follow an evidence-based and established dose-optimising approach, given by injection, twice per week for 4 weeks, then the frequency of further treatments (week 5 - month 6) will be based on the clinical judgement of the ketamine clinic psychiatrist.
Dosing will be adjusted by the ketamine clinic psychiatrist, based on clinical response, safety and tolerability. The psychiatrist will review the patient before each treatment, over the first 4 weeks, to judge the dose level required.
Typically, dosing will begin at the standard dose of 0.5 mg/kg and adjusted using an ascending dose titration schedule if the patient has not shown clinical response and if side effects are adequately tolerated.
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Treatment: Drugs: Esketamine group
The recommended dosing for Spravato is:
Weeks 1-4:
Starting Day 1 dose:
\< 65 years: 56 mg
= 65 years: 28 mg
Subsequent doses:
28 mg (= 65 years), 56 mg or 84 mg twice weekly
Weeks 5-8:
28 mg (= 65 years), 56 mg or 84 mg once weekly
From Week 9:
28 mg (= 65 years), 56 mg or 84 mg every 2 weeks or once weekly
Treatment: Drugs: Racemic ketamine
Typically, dosing will begin at the standard dose of 0.5 mg/kg and adjusted as needed using an ascending dose titration schedule:
1. 0.5 mg/kg
2. 0.6 mg/kg
3. 0.75 mg/kg
4. 0.9 mg/kg
5. Further increments by 0.1-0.2 mg/kg, up to max 1.5 mg/kg
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Montgomery-Asberg Depression Rating Scale (MADRS)
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Assessment method [1]
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Change in score on the Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS is sensitive to change, and is commonly used for treatment trials in depression.
MADRS includes questions on ten symptoms, each of which yields a score of 0 to 6. The total score ranges from 0 to 60. The higher the MADRS score the more severe the depression. Cutoff points are for levels of depression are:
0 to 6: normal /symptom absent 7 to 19: mild depression 20 to 34: moderate depression 35 to 60: severe depression.
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Timepoint [1]
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From week 0 to week 4.
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Secondary outcome [1]
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Montgomery-Asberg Depression Rating Scale (MADRS) score
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Assessment method [1]
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Score on the Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS is sensitive to change, and is commonly used for treatment trials in depression. See outcome 1 for minimum and maximum values, and whether higher scores indicate a better or worse outcome.
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Timepoint [1]
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At week 8 and month 6
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Secondary outcome [2]
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Response - Montgomery-Asberg Depression Rating Scale (MADRS)
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Assessment method [2]
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Response (=50% improvement in MADRS)
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Timepoint [2]
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Weeks 4, 8 and month 6
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Secondary outcome [3]
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Remission - Montgomery-Asberg Depression Rating Scale (MADRS)
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Assessment method [3]
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Remission (MADRS score =10)
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Timepoint [3]
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Weeks 4, 8 and month 6
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Secondary outcome [4]
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DASS-21
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Assessment method [4]
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Depression, Anxiety and Stress Scale (DASS-21) - will be used to measure psychological distress. It consists of three 7-item subscales, with items scored on a 4-point Likert scale (0-3) and summed to obtain subscale scores.
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Timepoint [4]
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Performed weekly from baseline to week 8 inclusive and at 6 month visit.
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Secondary outcome [5]
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Clinical Global Impression-Improvement (CGI-I)
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Assessment method [5]
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The Clinical Global Impression - Improvement scale (CGI-I) is used to assess depressive symptom improvement from study baseline. The minimum value is -6 (maximum deterioration) and the maximum value is 6 (ideal improvement).
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Timepoint [5]
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Performed weekly from week 1 to week 4 inclusive, then at week 8 and at 6 month visits.
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Secondary outcome [6]
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Clinical Global Impression-Severity (CGI-S)
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Assessment method [6]
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The Clinical Global Impression - Severity scale (CGI-S) is used to assess depressive symptom severity. The minimum value is 1 (normal) and the maximum value is 7 (among the most extremely ill patients).
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Timepoint [6]
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Performed weekly from baseline to week 4 inclusive, then at week 8 and at 6 month visits.
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Secondary outcome [7]
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Columbia Suicide Severity Rating Scale (C-SSRS)
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Assessment method [7]
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Columbia Suicide Severity Rating Scale (C-SSRS) - short questionnaire that will be used by the clinic teams as a clinical tool to assess suicidality.
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Timepoint [7]
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Performed weekly from baseline to week 4 inclusive, then at week 8 and at 6 month visits.
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Secondary outcome [8]
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Speed of response - Clinical Global Impression-Improvement (CGI-I)
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Assessment method [8]
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Speed of response, assessed by number of treatments required to attain CGI-I score of = 3.
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Timepoint [8]
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Performed weekly from week 1 to week 4 inclusive, then at week 8 and at 6 month visits.
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Secondary outcome [9]
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Psychotomimetic symptoms
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Assessment method [9]
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Assessed via the Ketamine Side Effect Tool (KSET), designed to monitor the acute, cumulative and longer-term safety of ketamine treatment.
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Timepoint [9]
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Through study completion at each treatment visit, up to 6 months
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Secondary outcome [10]
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Suicide attempts or gestures
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Assessment method [10]
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Data collected as an Adverse Event of Special Interest
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Timepoint [10]
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During 6-month study period
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Secondary outcome [11]
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Number of Participants with urinary symptoms, as assessed using the Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS)
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Assessment method [11]
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Bladder Pain-Interstitial Cystitis Symptom Score (BPIC-SS) - a self-report symptom-based instrument that identifies moderate to severe bladder pain syndrome. Side effects of racemic ketamine/Spravato® include inflammation of the bladder endothelium. From 8 questions about bladder/urination pain, patients can score a minimum of 0 (asymptomatic) and a maximum of 38 (severe symptoms).
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Timepoint [11]
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Performed at baseline, week 4, week 8 and at 6 month visit.
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Secondary outcome [12]
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Cognitive Failure Questionnaire scores (CFQ)
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Assessment method [12]
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Cognitive Failures Questionnaire (CFQ) is a self-rated tool to assess subjective impression of cognitive functioning. From 25 questions, patients can score a minimum of 0 (best) and a maximum of 100 (worst).
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Timepoint [12]
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Performed at baseline, week 4, week 8 and at 6 month visit.
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Secondary outcome [13]
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Ketamine liking/craving score
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Assessment method [13]
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Ketamine liking/craving score will be used as a measure of ketamine craving/abuse. A visual analogue scale is used, where patients can score a minimum of 0 (strong dislike/no craving) and a maximum of 30 (very strong liking/constant craving).
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Timepoint [13]
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Performed at baseline, week 4, week 8 and at 6 month visit.
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Secondary outcome [14]
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Number of Participants with urinary symptoms, as assessed using the Ketamine Side Effect Tool (KSET)
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Assessment method [14]
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Assessed via the Ketamine Side Effect Tool (KSET), designed to monitor the acute, cumulative and longer-term safety of ketamine treatment.
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Timepoint [14]
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Through study completion at each treatment visit, up to 6 months
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Secondary outcome [15]
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Acceptability Questionnaire
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Assessment method [15]
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An 8-item self-rated instrument to assess the acceptability of healthcare interventions. This evaluates the constructs of affective attitude, effort burden, ethicality, perceived effectiveness, intervention coherence, self-efficacy, opportunity costs and general acceptability. Patients can score a minimum of 8 (very unacceptable) and a maximum of 40(very acceptable).
"If reporting a score on a scale, please include the minimum and maximum values, and whether higher scores mean a better or worse outcome." Appears that not all high scores are positive so makes it hard to address this issue.
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Timepoint [15]
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Performed at week 4, week 8 and at 6 month visit.
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Secondary outcome [16]
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End of Treatment questionnaire
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Assessment method [16]
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Collected via case report form. Captures reason for ceasing, switching or re-starting study medication.
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Timepoint [16]
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Used at end of the treatment period(s) over the course of the study.
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Secondary outcome [17]
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Recovering Quality of Life Questionnaire (REQOL-10)
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Assessment method [17]
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Recovering Quality of Life, 10-item (REQOL-10) is used to assess the quality of life for people with different mental health conditions. Patients can score a minimum of 0 (poorest quality of life) and a maximum of 40 (highest quality of life).
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Timepoint [17]
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Over 6 month study period
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Secondary outcome [18]
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WHO Disability Assessment Scale (WHODAS-12)
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Assessment method [18]
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12-item WHO Disability Assessment Scale (WHODAS-12) is a 12-item self-rated assessment of health and disability. It will be used to assess functionality. Patients can score a minimum of 0 (no disability) and a maximum of 48 (complete disability).
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Timepoint [18]
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Over 6 month study period
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Secondary outcome [19]
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Patient Health Questionnaire-9 (PHQ-9)
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Assessment method [19]
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Patient Health Questionnaire-9 (PHQ-9) is a self-report screening tool designed to assess the severity of depressive symptoms in individuals and monitors symptom changes and treatment effects over time. Patients can score a minimum of 0 (no depression) and a maximum of 27 (severe depression).
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Timepoint [19]
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Over 6 month study period
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Secondary outcome [20]
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Assessment of Quality of Life Questionnaire (AQoL-8D)
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Assessment method [20]
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Assessment of Quality of Life Questionnaire (AQoL-8D) consists of 35 items covering 8 dimensions: Independent Living, Pain, Senses, Mental Health, Happiness, Coping, Relationships, and Self-worth. It will be used to assess quality of life outcomes and to facilitate the health economics analysis. There is a max patient score of 1 (perfect health) and a minimum score of 0 (deceased) based on weighted utility scores
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Timepoint [20]
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Over 6 month study period
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Secondary outcome [21]
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Resource Use Questionnaire (RUQ)
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Assessment method [21]
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The resource use questionnaire (RUQ) collects information regarding the type and number of contacts with the health system including hospitalisations, consultations and medications. The information is then 'scored' by multiplying indicative unit costs by the number of contacts for each service used. The costs per service are summed to calculate a total health sector cost.
The resource use questionnaire also collects information regarding time missed (absenteeism) and time working at reduced capacity (presenteeism) for paid work and time missed from unpaid work. The number of hours missed and working at reduced capacity from paid work will be valued using an average wage rate. The hours missed from unpaid work will be valued using a shadow cost for the value of leisure time. These costs are summed and combined with health sector costs to calculate societal costs.
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Timepoint [21]
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Over 6 month study period
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Secondary outcome [22]
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Treatment Preference
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Assessment method [22]
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The Treatment Preferences questionnaire is a simple 3 item self-report questionnaire which asks participants to indicate their treatment preference for one of the 2 interventions, if any; their strength of preference (slight, moderate or strong); their reason for preference (Prefer this method of receiving the medication; Had this treatment before and benefitted; Past negative experience with the other treatment; Impression from reports, other people or media; Other (please specify))
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Timepoint [22]
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Assessed once, prior to randomization
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Secondary outcome [23]
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Stanford Expectations of Treatment Scale (SETS)
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Assessment method [23]
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The SETS is a self-report questionnaire that assesses positive and negative treatment expectations with 6 items rated on a 7-point Likert scale from 0 'not agree at all' to 6 'fully agree'; additional questions ask the responder to confirm the treatment they will receive and whether they have received it before as well as whether any specific benefits or harms/negative side effects are expected
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Timepoint [23]
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Assessed once, after randomization and before first treatment
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/06/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2027
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Actual
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Sample size
Target
162
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Black Dog Institute - Randwick
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Recruitment hospital [3]
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Ramsay Clinic Northside - St Leonards
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Recruitment hospital [4]
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Ramsay Clinic Lakeside - Warners Bay
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Recruitment hospital [5]
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Gold Coast University Hospital - Southport
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Recruitment hospital [6]
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Ramsay Clinic Albert Road - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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2282 - Warners Bay
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Recruitment postcode(s) [5]
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4215 - Southport
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Recruitment postcode(s) [6]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The University of New South Wales
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06278779
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Colleen Loo
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Address
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The University of New South Wales
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Simone Jacoby
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Address
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Country
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Phone
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80524300
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06278779
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