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

Roche

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: RO4917523 0.5 mg; Drug: RO4917523 1.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01437657

NP25620

2011-001436-33 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 319 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

319 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching RO4917523 placebo orally daily, 6 weeks

Treatment:

Drug: Placebo

RO4917523 0.5 mg

Experimental group

Description:

0.5 mg orally daily, 6 weeks

Treatment:

Drug: RO4917523 0.5 mg

RO4917523 1.5 mg

Experimental group

Description:

1.5 mg orally daily, 6 weeks

Treatment:

Drug: RO4917523 1.5 mg