Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy
Status:
Active, not recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the intermediate-term efficacy and tolerability of a
multiple-dosing ketamine infusion paradigm for the treatment of medication-refractory major
depressive disorder (MDD). We are using a two-phase design. The first phase is a 3-week
double blind parallel design clinical trial comparing 6 infusions of ketamine compared to 6
infusions of midazolam in 24 adolescents with treatment resistant depression. The primary
outcome of this phase will be Children's Depression Rating Scale (CDRS) score at Day 18. The
second phase is a 6-month open phase in which patients who received midazolam and remain
depressed with be offered open ketamine treatment (6 infusions over 3 weeks). All
participants will be followed weekly for 6 months and tracked for time to relapse.