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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Placebo
* Drug: RO4917523 0.5 mg
* Drug: RO4917523 1.5 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Matching RO4917523 placebo orally daily, 6 weeks | Drug: Placebo<br>* Matching RO4917523 placebo orally daily, 6 weeks<br>|
| Experimental: RO4917523 0.5 mg<br>0.5 mg orally daily, 6 weeks | Drug: RO4917523 0.5 mg<br>* 0.5 mg orally daily, 6 weeks<br>|
| Experimental: RO4917523 1.5 mg<br>1.5 mg orally daily, 6 weeks | Drug: RO4917523 1.5 mg<br>* 1.5 mg orally daily, 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montgomery Asberg Depression Rating Scale (MADRS) |  | From baseline to Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Global Impression Score - Severity (CGI-S) |  | From baseline to Week 6 | 
| Change in Clinical Global Impression Score - Improvement (CGI-I) |  | From baseline to Week 6 | 
| Safety: Incidence of adverse events |  | approximately 2 years | 
| Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment |  | approximately 2 years | 
| Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment |  | approximately 2 years |