Data

Study of Ketamine for Youth Depression (SKY-D)

Orygen

Dataset description

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. It is hypothesised that ketamine will be an effective treatment for moderate-to-severe depression in young people.
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Source Study

Trial acronym

SKY-D

Trial ID

ACTRN12619000683134

Purpose

Treatment

Phase

Phase 3

Funding

Government body,National Health and Medical Research Council of Australia

Scientific enquiries

Prof Christopher Davey

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 wee ....
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Key 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 ....
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Key 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 ....
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Can healthy volunteers participate?

No

 

Population

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

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 ....
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Comparison

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.

Outcomes

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

Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

All of the individual participant data collected during the trial, after deidentification.

When will data be available?

Data will be available Immediately following publication, for an indefinite time

Available to whom?

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

Available for what types of analyses?

To any type of analyses. Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au