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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT01437657
• Date of registration: 20/09/2011
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: 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
• Scientific title: 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
• Date of first enrolment: October 2011
• Target sample size: 319
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01437657
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Chile, Germany, Japan, Mexico, Poland, Romania, Russian Federation, Taiwan, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: RO4917523 1.5 mg

Drug: RO4917523 0.5 mg

Drug: Placebo

Primary Outcome(s)

Change in Montgomery Asberg Depression Rating Scale (MADRS) [Time Frame: From baseline to Week 6]

Secondary Outcome(s)

Proportion of patients exhibiting remission (MADRS [Time Frame: approximately 2 years]

Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment [Time Frame: approximately 2 years]

Change in Clinical Global Impression Score - Improvement (CGI-I) [Time Frame: From baseline to Week 6]

Change in Clinical Global Impression Score - Severity (CGI-S) [Time Frame: From baseline to Week 6]

Safety: Incidence of adverse events [Time Frame: approximately 2 years]

Secondary ID(s)

2011-001436-33

NP25620

Source(s) of Monetary Support

Please refer to primary and secondary sponsors