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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: RO4917523 1.5 mg; Drug: RO4917523 0.5 mg

• Registration Number: NCT01437657
• Lead Sponsor: Hoffmann-La Roche

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 inadequate response to ongoing antidepressant therapy. Anticipated time on study treatment is 6 weeks with a 3-week follow-up.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-21
• Study Start: 2011-10
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Disposition First Submitted: 2016-07-06
• Disposition First Submitted QC: 2016-07-06
• Disposition First Posted: 2016-07-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 319

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching RO4917523 placebo orally daily, 6 weeks
RO4917523 1.5 mg	RO4917523 1.5 mg	1.5 mg orally daily, 6 weeks
RO4917523 0.5 mg	RO4917523 0.5 mg	0.5 mg orally daily, 6 weeks

Primary Outcome Measures

Name	Time	Method
Change in Montgomery Asberg Depression Rating Scale (MADRS)	From baseline to Week 6

Secondary Outcome Measures

Name	Time	Method
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
Safety: Incidence of adverse events	approximately 2 years
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