A multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of RO4995819 versus placebo, as adjunctive therapy in patients with major depressive disorder having inadequate response to ongoing antidepressant treatment
ID Number 12-0397Principal Investigator(s)
Dan V. Iosifescu
Department(s) or Division(s)
The objective of the current study is to investigate the safety and efficacy of study drug RO4995819 versus placebo as adjunctive treatment (taken in addition to ongoing antidepressant therapy) for 6 weeks in patients with major depressive disorder (MDD) with inadequate response to ongoing antidepressant therapy. Following screening procedures to confirm eligibility, patients receiving ongoing therapy with selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) antidepressants will be randomized to 1of 4 treatment arms: Group 1: 5 mg RO4995819 oral once daily for 6 weeks; Group 2: 15 mg RO4995819 oral once daily for 6 weeks; Group 3: 30 mg RO4995819 oral once daily for 6 weeks; Group 4: placebo oral once daily for 6 weeks. The total duration of the study will be up to 18 weeks for each enrolled patient and will involve a screening period (up to 4 weeks), dosing period (6 weeks), and follow-up (8 weeks). Eligible participants will receive treatment at no cost to them and compensation for their time.
Recruiting Patients: Yes