Exploring how ketamine affects the brain function in people with difficult-to-treat depression - NeuroKet 2.0
The University of MelbourneDataset description
*This study is ongoing, date on last data collection expected 20/12/2027. Data will be available to request following publication of the primary outcome paper, for an indefinite time. This dataset contains de identified clinical, behavioural, neuroimaging, and passive sensing data from an interventional randomised controlled study examining the neural and symptomatic effects of a single subcutaneous ketamine dose in adults with difficult to treat depression. Participants were randomised to receive ketamine (0.75 mg/kg) or saline placebo under medical supervision, with an additional healthy control group undergoing neuroimaging only. Ultra high field 7 Tesla functional MRI was conducted at baseline and 24-48 hours post intervention to assess habenula activity, connectivity, and photosensitivity, alongside clinician rated and self reported measures of depressive symptoms, anxiety, anhedonia, motivation, circadian preference, and quality of life. Objective behavioural and circadian measures were collected using actigraphy and passive mobile sensing before and after intervention. The dataset supports secondary analyses of ketamine's acute neural mechanisms, symptom change, and digitally derived behavioural markers in depression.Date Information
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12625001087448
Funding
Government body, National Health and Medical Research Council
Scientific enquiries
Christopher Davey
Brief Summary
The proposed intervention involves a single subcutaneous injection of ketamine (0.75 mg/kg) or a matched placebo (0.9% saline) administered to participants with difficult-to-treat depression (DTD). The intervention is delivered under double-blind conditions at the Royal Melbourne Hospital Clinical Trials Centre. The ketamine dose is administered once only and is not part of any ongoing therapeutic protocol. The intervention is designed to investigate neural and clinical changes following ketamin .... Read more
Key Inclusion Criteria
Clinical Participants • Age 18 – 65 at the time of informed consent; • Meets DSM-5 criteria for major depressive disorder (MDD), with a current major depressive episode (MDE), confirmed via the MINI • Insufficient response to at least 2 adequate trials of antidepressant medications, as determined by study doctor; • Ability to provide written informed consent (including adequate intellectual capacity and fluency in the English language), as determined by the, study doctor or delegate. Control Par .... Read more
Key Exclusion Criteria
Clinical Participants • Severe disturbance such that the patient would be unable to comply with study requirements • History or current diagnosis of a psychotic or bipolar disorder as assessed using the MINI • Any unstable medical condition, or medical or pharmaceutical contraindication to ketamine • Any history of a ketamine use disorder of any severity or moderate-to-severe substance use disorder (for other drugs) within the past 6 months • Contraindications to MRI Control Participants (health .... Read more
Can healthy volunteers participate?
Yes
Population
Sample Size 90
Min. age 18 Years
Max. age 65 Years
Sex Both males and females
Condition category Major Depressive Disorder
Condition code Mental Health
Intervention
Intervention code Treatment: Drugs
Participants with difficult-to-treat depression will receive a single subcutaneous injection of 0.75mg/kg ketamine. The intervention is administered under medical supervision in a controlled clinical setting. Neuroimaging assessments (7T fMRI) will be conducted pre- and 24-48 hours post-injection to evaluate changes in habenula activity and connectivity.
Comparison
Control group Placebo
This study will be conducted as a 2-arm RCT where the clinical control group will include DTD participants. An additional healthy control group will also be included, these participants will not be randomised to receive any injections and will only undergo a single fMRI scan. Participants in the control group will receive a single subcutaneous injection of 0.9% saline (placebo), matched in volume and appearance. Procedures for neuroimaging and symptom assessment will be identical to the active a .... Read more
Outcomes
Outcome: Change in habenula activity from baseline to 24-48 hours post-intervention, measured via BOLD signal using ultra-high field (7T) functional MRI following a single subcutaneous injection of 0.75mg/kg ketamine.Timepoint: Baseline and then one time point that must fall within 24-48 hours post-injection.
Will the study consider sharing individual participant data?
Yes
Who can request access to individual participant data?
Researchers
Are there any conditions for requesting access to individual participant data?
Yes, conditions apply
Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
All de-identified individual participant data
What types of analyses could be done with individual participant data?
Any type of analysis (i.e. no restrictions on data re-use)
Systematic reviews and meta-analyses
Studies exploring new research questions
Studies testing whether findings can be repeated or confirmed
Teaching research methods or developing new statistical techniques
Are there extra considerations when requesting access to individual participant data?
No
When can request for individual data be made (start and end dates)?
From: After publication of main results
To: No end date