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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

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ClinicalTrials.gov Identifier: NCT01437657
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE September 20, 2011
First Posted Date  ICMJE September 21, 2011
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE October 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
Change in Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: From baseline to Week 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2014)
319
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2011)
315
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Germany,   Japan,   Mexico,   Poland,   Romania,   Russian Federation,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01437657
Other Study ID Numbers  ICMJE NP25620
2011-001436-33 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Disclosures Group, Hoffmann-La Roche
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

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