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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: RO4917523 0.5 mg; Drug: RO4917523 1.5 mg

• Study Type: Interventional
• Enrollment (Actual): 319
• Phase: Phase 2

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile, 7500710
  • Santiago, Chile, 7580307
  • Temuco, Chile, 4781151
• Germany
  • Berlin, Germany, 10117
  • Berlin, Germany, 12203
  • Freiburg, Germany, 79104
  • Hannover, Germany, 30159
  • Mainz, Germany, 55131
  • Wiesbaden, Germany, 65185
• Japan
  • Chuo-ku, Japan, 260-8670
  • Hokkaido, Japan, 060-8648
  • Hyogo, Japan, 659-0093
  • Kanagawa, Japan, 216-8511
  • Kanagawa, Japan, 252-0303
  • Kita-Ku, Japan, 114-0024
  • Kurayoshi-shi, Japan, 682-0023
  • Kyoto, Japan, 618-8421
  • Osaka, Japan, 569-1041
  • Shinjuku-ku, Japan, 160-8582
  • Tokyo, Japan, 151-0053
  • Tokyo, Japan, 170-0002
  • Tokyo, Japan, 187-8551
  • Tokyo, Japan, 162-8666
  • Tokyo, Japan, 100-0006
  • Tokyo, Japan, 107-0052
  • Tokyo, Japan, 157-8577
  • Tokyo, Japan, 162-0821
• Mexico
  • Aguascalientes, Mexico, 20127
  • Leon, Mexico, 37000
  • Monterrey, Mexico, 64060
• Poland
  • Belchatow, Poland, 97-400
  • Bialystok, Poland, 15-879
  • Bialystok, Poland, 15-464
  • Choroszcz, Poland, 16-070
  • Kielce, Poland, 25-411
  • Lodz, Poland, 91-229
  • Tuszyn, Poland, 95-080
• Romania
  • Bucuresti, Romania, 030442
  • Bucuresti, Romania, 031723
  • Constanta, Romania, 900002
  • Craiova, Romania, 200620
  • Targouiste, Romania, 130086
  • Targu Mures, Romania, 540139
• Russian Federation
  • St. Petersburg, Russian Federation, 190121
  • St. Petersburg, Russian Federation, 192019
• Taiwan
  • Keelung, Taiwan, 20445
  • Taichung, Taiwan, 40447
  • Taipei, Taiwan, 00112
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72223
  • California
    • Costa Mesa, California, United States, 92626
    • Garden Grove, California, United States, 92845
    • Oceanside, California, United States, 92056
    • Orange, California, United States, 92868
    • Riverside, California, United States, 92506
    • San Diego, California, United States, 92103
    • San Diego, California, United States, 92102
    • San Diego, California, United States, 92121
    • Santa Ana, California, United States, 92705
    • Wildomar, California, United States, 92595
  • Georgia
    • Atlanta, Georgia, United States, 30328
  • Illinois
    • Libertyville, Illinois, United States, 60048
    • Naperville, Illinois, United States, 60563
    • Oak Brook, Illinois, United States, 60523
  • Louisiana
    • Shreveport, Louisiana, United States, 71115
  • Maryland
    • Baltimore, Maryland, United States, 21285
  • Nevada
    • Las Vegas, Nevada, United States, 89102
  • New Jersey
    • Marlton, New Jersey, United States, 08053
  • New York
    • Brooklyn, New York, United States, 11201
    • Cedarhurst, New York, United States, 11516
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
  • Pennsylvania
    • Norristown, Pennsylvania, United States, 19403
    • Philadelphia, Pennsylvania, United States, 19104
    • Philadelphia, Pennsylvania, United States, 19139
    • Pittsburgh, Pennsylvania, United States, 15213
  • Tennessee
    • Memphis, Tennessee, United States, 38119
  • Washington
    • Kirkland, Washington, United States, 98033

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching RO4917523 placebo orally daily, 6 weeks	Drug: Placebo; Matching RO4917523 placebo orally daily, 6 weeks
Experimental: RO4917523 0.5 mg; 0.5 mg orally daily, 6 weeks	Drug: RO4917523 0.5 mg; 0.5 mg orally daily, 6 weeks
Experimental: RO4917523 1.5 mg; 1.5 mg orally daily, 6 weeks	Drug: RO4917523 1.5 mg; 1.5 mg orally daily, 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Montgomery Asberg Depression Rating Scale (MADRS)	From baseline to Week 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	approximately 2 years
Change in Clinical Global Impression Score - Severity (CGI-S)	From baseline to Week 6
Change in Clinical Global Impression Score - Improvement (CGI-I)	From baseline to Week 6
Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment	approximately 2 years
Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment	approximately 2 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: September 20, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (Estimate): September 21, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: NP25620; 2011-001436-33 (EudraCT Number)