Study of Ketamine for Youth Depressio

Phase 3

Active, not recruiting

• Conditions: Major Depressive Disorder; Mental Health - Depression

• Registration Number: ACTRN12619000683134
• Lead Sponsor: Orygen, the National Centre of Excellence in Youth Mental Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-07
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is change in depression scores, defined as a reduction in the researcher-rated MADRS at 4 weeks compared with baseline MADRS. [ Week 4 (Day 28) Follow-up]