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

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.

Timeline

Start

2011-10

Primary completion

2013-09

Completion

2013-09

Outcome

Missed primary endpoint

paper The primary end point (mean change in clinician-rated MADRS score from baseline to end of treatment) was not met PMID 27304433 ↗

paper No difference was observed on the study's primary outcome measure PMID 27304433 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Basimglurant	Small molecule	0.5 mg	Oral
Subject	Basimglurant	Small molecule	1.5 mg	Oral

Indications