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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01437657
First Posted: September 21, 2011
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
September 20, 2011
September 21, 2011
November 2, 2016
October 2011
September 2013   (Final data collection date for primary outcome measure)
Change in Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: From baseline to Week 6 ]
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 ]
  • Change in Clinical Global Impression Score - Improvement (CGI-I) [ Time Frame: From baseline to Week 6 ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ]
  • Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment [ 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 ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Placebo
    Matching RO4917523 placebo orally daily, 6 weeks
  • Drug: RO4917523 0.5 mg
    0.5 mg orally daily, 6 weeks
  • Drug: RO4917523 1.5 mg
    1.5 mg orally daily, 6 weeks
  • Placebo Comparator: Placebo
    Matching RO4917523 placebo orally daily, 6 weeks
    Intervention: Drug: Placebo
  • Experimental: RO4917523 0.5 mg
    0.5 mg orally daily, 6 weeks
    Intervention: Drug: RO4917523 0.5 mg
  • Experimental: RO4917523 1.5 mg
    1.5 mg orally daily, 6 weeks
    Intervention: Drug: RO4917523 1.5 mg
Quiroz JA, Tamburri P, Deptula D, Banken L, Beyer U, Rabbia M, Parkar N, Fontoura P, Santarelli L. Efficacy and Safety of Basimglurant as Adjunctive Therapy for Major Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jul 1;73(7):675-84. doi: 10.1001/jamapsychiatry.2016.0838.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
319
September 2013
September 2013   (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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Chile,   Germany,   Japan,   Mexico,   Poland,   Romania,   Russian Federation,   Taiwan,   United States
 
 
NCT01437657
NP25620
2011-001436-33 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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