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

Major Depressive Disorder Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437657
• Other study ID #: NP25620
• Secondary ID: 2011-001436-33
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2011
• Last updated: November 1, 2016
• Start date: October 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Placebo
Matching RO4917523 placebo orally daily, 6 weeks
• RO4917523 0.5 mg
0.5 mg orally daily, 6 weeks
• RO4917523 1.5 mg
1.5 mg orally daily, 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery Asberg Depression Rating Scale (MADRS)		From baseline to Week 6	No
Secondary	Change in Clinical Global Impression Score - Severity (CGI-S)		From baseline to Week 6	No
Secondary	Change in Clinical Global Impression Score - Improvement (CGI-I)		From baseline to Week 6	No
Secondary	Safety: Incidence of adverse events		approximately 2 years	No
Secondary	Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment		approximately 2 years	No
Secondary	Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment		approximately 2 years	No