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. 2021 Sep 12;2021(9):CD011612. doi: 10.1002/14651858.CD011612.pub3

NCT01482221.

Methods A Multicentre, randomised, double‐blind, parallel group, placebo‐controlled, phase IIb efficacy and safety study of adjunctive AZD6765 in patients with major depressive disorder (MDD) and a history of inadequate response to antidepressants
Participants Male or female patients aged 18 to 70 years, inclusive. The patient must have a clinical diagnosis of major depressive disorder with a lifetime history of inadequate response to at least 3 antidepressants
Interventions Arm 1: 50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by IV infusion; Arm 2: 100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by IV infusion; Arm 3: 0.9 sodium chloride [normal saline] solution for injection by IV infusion
Outcomes Change from baseline to Week 6 in the Montgomery‐Asberg Depression Rating Scale (MADRS) total score. Time frame: will be scored at weeks 1 (baseline), 2, 3, 4, 5 and 6
Notes