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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01437657

Enrollment

319

Registered

2011-09-21

Start date

2011-10-31

Completion date

2013-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

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.

Interventions

DRUGPlacebo

Matching RO4917523 placebo orally daily, 6 weeks

DRUGRO4917523 0.5 mg

0.5 mg orally daily, 6 weeks

DRUGRO4917523 1.5 mg

1.5 mg orally daily, 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Chile, Germany, Japan, Mexico, Poland, Romania, Russia, Taiwan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026