This randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on study treatment is 6 weeks with a 3-week follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
319
Matching RO4917523 placebo orally daily, 6 weeks
0.5 mg orally daily, 6 weeks
1.5 mg orally daily, 6 weeks
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: From baseline to Week 6
Change in Clinical Global Impression Score - Severity (CGI-S)
Time frame: From baseline to Week 6
Change in Clinical Global Impression Score - Improvement (CGI-I)
Time frame: From baseline to Week 6
Safety: Incidence of adverse events
Time frame: approximately 2 years
Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment
Time frame: approximately 2 years
Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment
Time frame: approximately 2 years
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Little Rock, Arkansas, United States
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Costa Mesa, California, United States
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Garden Grove, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Riverside, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
...and 66 more locations