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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

September 20, 2011
May 13, 2013
October 2011
January 2014   (final data collection date for primary outcome measure)
Change in Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: From baseline to Week 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01437657 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Depression Disorder, Major
  • Drug: RO4917523
    0.5 mg orally daily, 6 weeks
  • Drug: RO4917523
    1.5 mg orally daily, 6 weeks
  • Drug: Placebo
    matching RO4917523 placebo orally daily, 6 weeks
  • Experimental: A
    Intervention: Drug: RO4917523
  • Experimental: B
    Intervention: Drug: RO4917523
  • Placebo Comparator: C
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Please reference Study ID Number: NP25620 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
United States,   Chile,   Germany,   Japan,   Mexico,   Poland,   Romania,   Russian Federation,   Taiwan
 
NCT01437657
NP25620, 2011-001436-33
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP