A Multicenter, Randomized, 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
ID Number 12-0829Principal Investigator(s)
Dan V. Iosifescu
Department(s) or Division(s)
This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled, Phase IIb efficacy and safety study of 2 dose groups conducted at approximately 50 sites in male and female outpatients between the ages of 18 and 70 years old, inclusive, with Major Depressive Disorder (MDD) and a lifetime history of inadequate response to 3 or more antidepressant treatments. The study will consist of a screening period of up to 42 days (or ≤6 weeks).
Following screening procedures to confirm eligibility, patients will be randomized to a 12-week, double-blind, outpatient infusion treatment period of AZD6765iv 50 mg, 100 mg, or placebo, followed by an 8-week observation period. All treatments will be given over 60 minutes and given once per day on non-consecutive days. There will be 3 infusions administered per week during Weeks 1 through 3 (1 per day on non-consecutive days), 1 infusion per week during Weeks 4 through 6, and 1 infusion every other week during Weeks 7 through 12 (i.e., infusion to occur during Week 8, Week 10, and Week 12).
Recruiting Patients: Yes