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A phase I, multi-centre, double-blind, placebo-controlled parallel group study to assess the pharmacoMRI effects of AZD6765 in male and female patients fulfilling the criteria for Major Depressive Disorder
TerminatedResults publishedRegisteredEudraCT
Phase I/II, randomised, double-blind, placebo-controlled study (n=60; terminated) assessing single-dose IV ketamine (Part 1) and AZD6765 (Part 2) versus placebo on BOLD pharmacoMRI signal in subjects with Major Depressive Disorder.
Details
This multi-centre study randomised patients with DSM-IV major depressive disorder to receive a single IV infusion of ketamine (Part 1) or AZD6765 (Part 2) versus placebo to assess pharmacoMRI effects on BOLD signal in BA25 and other regions.
Secondary assessments included effects on emotional processing in amygdala and other areas, safety and pharmacodynamic/pharmacokinetic measures; follow-up visit occurred approximately 8–11 days after infusion for unresolved adverse events.
Topics:Major Depressive Disorder (MDD)
Registry
Registry link2009-013110-27