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

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01437657

Run by

Hoffmann-La Roche

People needed

319

Starts

2011-10-01

Expected to finish

2013-09-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Costa Mesa, California, United States
• Study site — Garden Grove, California, United States
• Study site — Oceanside, California, United States
• Study site — Orange, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Ana, California, United States
• Study site — Wildomar, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Libertyville, Illinois, United States
• Study site — Naperville, Illinois, United States
• Study site — Oak Brook, Illinois, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Marlton, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — Cedarhurst, New York, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Norristown, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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