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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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01437657
First received: September 20, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Depression Disorder, Major
 Drug: RO4917523
Drug: Placebo
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: From baseline to Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Clinical Global Impression Score - Severity (CGI-S) [ Time Frame: From baseline to Week 6 ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression Score - Improvement (CGI-I) [ Time Frame: From baseline to Week 6 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: RO4917523
0.5 mg orally daily, 6 weeks
Experimental: B Drug: RO4917523
1.5 mg orally daily, 6 weeks
Placebo Comparator: C Drug: Placebo
matching RO4917523 placebo orally daily, 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437657

Contacts
Contact: Please reference Study ID Number: NP25620 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 67 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01437657     History of Changes
Other Study ID Numbers: NP25620, 2011-001436-33
Study First Received: September 20, 2011
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013