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
NCT ID: NCT01437657
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
319 participants
INTERVENTIONAL
2011-10-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Matching RO4917523 placebo orally daily, 6 weeks
Placebo
Matching RO4917523 placebo orally daily, 6 weeks
RO4917523 0.5 mg
0.5 mg orally daily, 6 weeks
RO4917523 0.5 mg
0.5 mg orally daily, 6 weeks
RO4917523 1.5 mg
1.5 mg orally daily, 6 weeks
RO4917523 1.5 mg
1.5 mg orally daily, 6 weeks
Interventions
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Placebo
Matching RO4917523 placebo orally daily, 6 weeks
RO4917523 0.5 mg
0.5 mg orally daily, 6 weeks
RO4917523 1.5 mg
1.5 mg orally daily, 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Little Rock, Arkansas, United States
Costa Mesa, California, United States
Garden Grove, California, United States
Oceanside, California, United States
Orange, California, United States
Riverside, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
Santa Ana, California, United States
Wildomar, California, United States
Atlanta, Georgia, United States
Libertyville, Illinois, United States
Naperville, Illinois, United States
Oak Brook, Illinois, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Las Vegas, Nevada, United States
Marlton, New Jersey, United States
Brooklyn, New York, United States
Cedarhurst, New York, United States
Oklahoma City, Oklahoma, United States
Norristown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Memphis, Tennessee, United States
Kirkland, Washington, United States
Santiago, , Chile
Santiago, , Chile
Temuco, , Chile
Berlin, , Germany
Berlin, , Germany
Freiburg im Breisgau, , Germany
Hanover, , Germany
Mainz, , Germany
Wiesbaden, , Germany
Chūōku, , Japan
Hokkaido, , Japan
Hyōgo, , Japan
Kanagawa, , Japan
Kanagawa, , Japan
Kita-ku, , Japan
Kurayoshi-shi, , Japan
Kyoto, , Japan
Osaka, , Japan
Shinjuku-ku, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Aguascalientes, , Mexico
León, , Mexico
Monterrey, , Mexico
Bełchatów, , Poland
Bialystok, , Poland
Bialystok, , Poland
Choroszcz, , Poland
Kielce, , Poland
Lodz, , Poland
Tuszyn, , Poland
Bucharest, , Romania
Bucharest, , Romania
Constanța, , Romania
Craiova, , Romania
Targouiste, , Romania
Târgu Mureş, , Romania
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Keelung, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Countries
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References
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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.
Other Identifiers
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2011-001436-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NP25620
Identifier Type: -
Identifier Source: org_study_id