This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.
A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
131
Research Site
Garden Grove, California, United States
Research Site
San Diego, California, United States
Research Site
Jacksonville, Florida, United States
MADRS Total Score Change From Baseline to Week 6
Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.
Time frame: 6 weeks
MADRS Response
A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.
Time frame: 6 weeks
MADRS Remission
A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6
Time frame: 6 weeks
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Research Site
Atlanta, Georgia, United States
Research Site
Rockville, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Cedarhurst, New York, United States
Research Site
Rochester, New York, United States
Research Site
Portland, Oregon, United States
Research Site
Memphis, Tennessee, United States
...and 3 more locations