Ketamine molecule:

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Ketamine Clinical Trials

Ketamine for Severe Adolescent Depression: Intermediate-term Safety and Efficacy

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Id: NCT03889756

Organisation Name: Yale University

Overal Status: Active, not recruiting

Start Date: July 17, 2019

Last Update: April 15, 2022

Lead Sponsor: Yale University

Brief 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.

  • Major Depressive Disorder

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