This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with major depressive disorder having inadequate response to ongoing antidepressant treatment. Patients will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or matching placebo. The anticipated time on study treatment is 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
357
Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores
Time frame: 6 weeks
Safety (incidence of a adverse events)
Time frame: 6 weeks
Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10)
Time frame: 6 weeks
Proportion of patients exhibiting response based on the Montgomery Asberg Depression Rating Scale (MADRS) (reduction in score of >/= 50% of the baseline score)
Time frame: 6 weeks
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30 mg oral once daily for 6 weeks
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Phoenix, Arizona, United States
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Oakland, California, United States
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Redlands, California, United States
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San Diego, California, United States
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Stanford, California, United States
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Torrance, California, United States
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Victorville, California, United States
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Denver, Colorado, United States
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Coral Springs, Florida, United States
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Gainsville, Florida, United States
...and 82 more locations