Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 inade...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT01437657
Start Date
October 1 2011
End Date
September 1 2013
Last Update
November 2 2016
Active Locations (76)
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1
Little Rock, Arkansas, United States, 72223
2
Costa Mesa, California, United States, 92626
3
Garden Grove, California, United States, 92845
4
Oceanside, California, United States, 92056