Treatment Programs at the Yale Depression Research Program

Yale University
Dept. of Psychiatry
300 George Street
New Haven, CT
06511 USA

Tel: 203-785-2117

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Research Clinics

An inpatient, clinical trial evaluating the safety and efficacy of an investigation drug for the treatment of major depressive disorder (MDD)

An exploratory adaptive fixed dose randomized, double-blind, parallel-group, placebo-controlled study of the safety and therapeutic effects of RO4917523 in patients with treatment resistant depression (TRD)
[HIC# 0902004723]
ClinicalTrials.gov Identifies: NCT00809562

Many patients with depression do not respond to current available antidepressant treatments or experience a recurrence of symptoms once improvement has been achieved. This study is designed to evaluate the tolerability and safety of RO4917523, a drug being developed by Hoffman-La Roche, in subjects with severe unipolar depression and a history of poor response to antidepressants. The study has both outpatient and inpatient phases. If eligible, subjects will first enter the prescreening outpatient phase. Subjects already on an antidepressant will continue on it for 4 to 6 weeks, and subjects not on an antidepressant will be prescribed one for 6 to 8 weeks. The purpose of this period is to confirm treatment resistance.

If treatment resistance is confirmed, subjects will have the option of continuing on in the study. In order to enter the treatment phase of the study, subjects must completely wash off their antidepressant. This will take between 2 and 5 weeks. If eligibility criteria is still met, subjects will have the option to enter the double-blind study drug phase. This phase will be conducted at the Clinical Neuroscience Inpatient Unit at the Connecticut Mental Health Center. Subjects will receive either the active drug or placebo for ten days. Subjects will remain on the CNRU for an additional five days and then will be followed as an outpatient for another ten days.

Last modified: May 26, 2009