SKY-D
ACTRN12619000683134
Treatment
Phase 3
Government body,National Health and Medical Research Council of Australia
Prof Christopher Davey
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 wee .... Read more
• 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 .... Read more
• 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 .... Read more
No
Sample Size 110
Min. age 16 Years
Max. age 25 Years
Sex Both males and females
Condition category Major Depressive Disorder
Condition code Mental Health
Intervention code Treatment: Drugs
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 .... Read more
Control group Active
The control treatment in SKY-D is low-dose midazolam, administered once a week for 4 weeks. All treatments will be administered using subcutaneous injection. The starting dose of midazolam is 0.03mg/kg. Participants with inadequate treatment response will be provided with an increased dose, up to a maximum dose of 0.045mg/kg of midazolam. Those who are unable to tolerate the starting dose will have their dosage reduced for subsequent treatments to a minimum of 0.025mg/kg of midazolam.
Outcome: The primary outcome is change in depression scores, defined as a reduction in the researcher-rated MADRS at 4 weeks compared with baseline MADRS. Timepoint: Week 4 (Day 28) Follow-up
yes
All of the individual participant data collected during the trial, after deidentification.
Data will be available Immediately following publication, for an indefinite time
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data sharing policy
To any type of analyses. Assessed on a case-by-case basis