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

NCT01437657 | Completed Phase 2

• 2 other identifiers: NP256202011-001436-33
• Study Type: interventional
• Target: 319
• Locations: 9 countries
• Sites: 76

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery Asberg Depression Rating Scale (MADRS)

  From baseline to Week 6

Secondary Outcomes (5)

• 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

• Safety: Incidence of adverse events

  approximately 2 years

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Matching RO4917523 placebo orally daily, 6 weeks

Drug: Placebo

RO4917523 0.5 mg

EXPERIMENTAL

0.5 mg orally daily, 6 weeks

Drug: RO4917523 0.5 mg

RO4917523 1.5 mg

EXPERIMENTAL

1.5 mg orally daily, 6 weeks

Drug: RO4917523 1.5 mg

Interventions

Placebo DRUG

Matching RO4917523 placebo orally daily, 6 weeks

Placebo

RO4917523 0.5 mg DRUG

0.5 mg orally daily, 6 weeks

RO4917523 0.5 mg

RO4917523 1.5 mg DRUG

1.5 mg orally daily, 6 weeks

RO4917523 1.5 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (76)

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Little Rock, Arkansas, 72223, United States

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Costa Mesa, California, 92626, United States

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Garden Grove, California, 92845, United States

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Oceanside, California, 92056, United States

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Orange, California, 92868, United States

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Riverside, California, 92506, United States

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San Diego, California, 92102, United States

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San Diego, California, 92103, United States

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San Diego, California, 92121, United States

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Santa Ana, California, 92705, United States

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Wildomar, California, 92595, United States

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Atlanta, Georgia, 30328, United States

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Libertyville, Illinois, 60048, United States

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Naperville, Illinois, 60563, United States

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Oak Brook, Illinois, 60523, United States

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Shreveport, Louisiana, 71115, United States

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Baltimore, Maryland, 21285, United States

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Las Vegas, Nevada, 89102, United States

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Marlton, New Jersey, 08053, United States

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Brooklyn, New York, 11201, United States

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Cedarhurst, New York, 11516, United States

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Oklahoma City, Oklahoma, 73112, United States

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Norristown, Pennsylvania, 19403, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19139, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Memphis, Tennessee, 38119, United States

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Kirkland, Washington, 98033, United States

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Santiago, 7500710, Chile

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Santiago, 7580307, Chile

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Temuco, 4781151, Chile

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Berlin, 10117, Germany

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Berlin, 12203, Germany

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Freiburg im Breisgau, 79104, Germany

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Hanover, 30159, Germany

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Mainz, 55131, Germany

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Wiesbaden, 65185, Germany

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Chūōku, 260-8670, Japan

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Hokkaido, 060-8648, Japan

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Hyōgo, 659-0093, Japan

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Kanagawa, 216-8511, Japan

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Kanagawa, 252-0303, Japan

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Kita-ku, 114-0024, Japan

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Kurayoshi-shi, 682-0023, Japan

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Kyoto, 618-8421, Japan

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Osaka, 569-1041, Japan

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Shinjuku-ku, 160-8582, Japan

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Tokyo, 100-0006, Japan

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Tokyo, 107-0052, Japan

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Tokyo, 151-0053, Japan

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Tokyo, 157-8577, Japan

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Tokyo, 162-0821, Japan

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Tokyo, 162-8666, Japan

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Tokyo, 170-0002, Japan

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Tokyo, 187-8551, Japan

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Aguascalientes, 20127, Mexico

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León, 37000, Mexico

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Monterrey, 64060, Mexico

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Bełchatów, 97-400, Poland

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Bialystok, 15-464, Poland

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Bialystok, 15-879, Poland

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Choroszcz, 16-070, Poland

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Kielce, 25-411, Poland

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Lodz, 91-229, Poland

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Tuszyn, 95-080, Poland

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Bucharest, 030442, Romania

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Bucharest, 031723, Romania

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Constanța, 900002, Romania

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Craiova, 200620, Romania

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Targouiste, 130086, Romania

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Târgu Mureş, 540139, Romania

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Saint Petersburg, 190121, Russia

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Saint Petersburg, 192019, Russia

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Keelung, 20445, Taiwan

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Taichung, 40447, Taiwan

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Taipei, 00112, Taiwan

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Related Publications (1)

• 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.

  PMID: 27304433 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 21, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

JP (18); ME (3); RO (6); DE (6); CL (3); PL (7); RU (2); TW (3); US (28)