None listed
Conditions
Brief summary
The primary aim of this research project is to determine if a 4-week course of low-dose subcutaneous ketamine is an effective treatment for young people (males and females aged 16-25 years) with moderate-to-severe depression. Participants will be randomised to receive either low-dose subcutaneous ketamine or a blinded control treatment that is therapeutically inactive (midazolam), given once a week for 4 weeks. Change in depression scores will be assessed at the end of the treatment phase at week 4, with further assessment at weeks 8 and 26 to assess whether treatment effects are sustained. We hypothesise that ketamine will be an effective treatment for moderate-to-severe depression in young people.
Interventions
The intervention in SKY-D is low-dose ketamine, administered once a week for 4 weeks. All treatments will be administered using subcutaneous injection. The starting dose (Level 1) of ketamine is 0.6mg/kg. Participants with inadequate treatment response will be provided with an increased dose, up to a maximum dose of 0.9mg/kg of ketamine. Those who are unable to tolerate the starting dose will have their dosage reduced for subsequent treatments to a minimum of 0.5mg/kg of ketamine (Level 0). Abil
The intervention in SKY-D is low-dose ketamine, administered once a week for 4 weeks. All treatments will be administered using subcutaneous injection. The starting dose (Level 1) of ketamine is 0.6mg/kg. Participants with inadequate treatment response will be provided with an increased dose, up to a maximum dose of 0.9mg/kg of ketamine. Those who are unable to tolerate the starting dose will have their dosage reduced for subsequent treatments to a minimum of 0.5mg/kg of ketamine (Level 0). Ability to tolerate dose will be determined based on participant subjective report and objective observations taken over four hours for the first treatment, and two hours for treatments 2, 3 and 4.
Sponsors
Orygen, the National Centre of Excellence in Youth Mental Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
• Age 16–25 years inclusive at the time of providing informed consent; • Current MDD as assessed using the Structured Clinical Interview for DSM-5 (SCID-5); • MADRS score greater than or equal to 22 – equivalent to moderate-to-severe depression – within 7 days (Day -7 to Day -1) of the first treatment visit; • Treatment with either a stable dose of an antidepressant or no antidepressant medication for greater than or equal to 2 weeks; • Ability to provide written informed consent (including both adequate intellectual capacity and fluency in the English language).
Exclusion criteria
• Severe disturbance such that the young person would be unable to comply with the requirements of informed consent or comply with the study protocol, as determined by the trial doctor; • History of psychosis or bipolar disorder (assessed with SCID-5); • Any unstable medical or neurologic condition, or medical or pharmaceutical contraindication to ketamine or midazolam use (as indicated in the Product Information forms for ketamine and midazolam); • Any history of a ketamine use disorder of any severity, or presence of a substance use disorder of at least moderate severity (DSM-5) within the preceding 6 months, as determined by the trial doctor; • Females who are pregnant or currently breastfeeding, or who are not using effective contraception. • Participation in any other clinical intervention trial from SKY-D baseline to the Week 8 follow-up.
Outcome results
None listed