MARIGOLD Study: A Study of RO4917523 Versus Placebo as Adjunctive Therapy in Patients With Major Depressive Disorder and an Inadequate Response to Ongoing Antidepressant Therapy

Status:	Completed
Conditions:	Depression, Major Depression Disorder (MDD)
Therapuetic Areas:	Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - 70
Updated:	8/3/2016
Start Date:	October 2011
End Date:	September 2013

A Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of RO4917523 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder With Inadequate Response to Ongoing Antidepressant Treatment

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.

Inclusion Criteria:

- Adult patient, 18 to 70 years of age at time of informed consent

- Major depressive disorder without psychotic features as defined by DSM-IV-TR criteria

- Inadequate response to ongoing antidepressant treatment, as defined by protocol

- Body mass index (BMI) 18 to 38 kg/m2 inclusive

Exclusion Criteria:

- Currently receiving treatment with a combination of antidepressants (two or more), or
an adjunctive potentiating treatment as defined by protocol

- Previously received RO4917523

- History of failure, or utilization during the current episode of Electroconvulsive
Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)

- History of use at any time of Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation
(DBS)

- Current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed
episodes)

- Pregnant or lactating women

We found this trial at

sites

Clinical Trial Facility in Kirkland Washington

Kirkland, Washington 98034

from

Kirkland, WA