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

NCT01046630.

Methods This was a multicentre, double‐blind, placebo‐controlled, parallel group study in males and females with Major Depressive Disorder (MDD). The maximum study period is approximately 42 days (6 weeks) for individual participants. The study was divided into two parts. Participants in Part 1 were randomised 1:1 to ketamine or placebo; participants in Part 2 were randomised 2:2:5 to ketamine, placebo or AZD6765. Study procedures were the same in both Part 1 and Part 2
Participants Sixty‐four male and female participants between the ages of 18 and 45 years old with MDD were to be randomised to obtain 60 evaluable participants. Twenty‐four evaluable participants in Part 1 (12 per arm; ketamine and placebo) and 36 evaluable participants in Part 2 (20 AZD6765, 8 ketamine and 8 placebo)
Interventions AZD6765: participants received a single infusion of AZD6765 100 mg (15 mg/mL, IV infusion). The infusion was of a final maximum volume of 40 mL given over 60 minutes
Batch number(s): 10‐003824AZ and 10‐005001AZ
Ketamine: participants received a single infusion of ketamine 0.5 mg/kg (10 mg/mL Injection) intravenously. The infusion was of a final maximum volume of 40 mL given over 60 minutes
Batch number(s): 42800A and 09‐008003AZ
Outcomes Primary: BOLD signal in the BA25 area
Notes