ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant Treatment

Roche

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: RO4995819; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01457677

BP25712

Details and patient eligibility

About

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with major depressive disorder having inadequate response to ongoing antidepressant treatment. Patients will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or matching placebo. The anticipated time on study treatment is 6 weeks.

Enrollment: 357 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, 18-65 years of age
• Major depression disorder without psychotic features
• Inadequate response to current, ongoing antidepressant treatment as defined by protocol
• Having at least one but no more than 2 antidepressant treatment trial failures
• Body mass index (BMI) 18.0-35.0 kg/m2 inclusive

Exclusion criteria

• Patient currently receives treatment with a combination of 3 or more antidepressants
• Significant ongoing use of high doses of barbiturates, benzodiazepines or other anxiolytic drugs
• Patient previously received RO4995819
• Patient participated in an investigational drug or device trial within 6 months of screening
• History of non-response to, or current use of non-pharmacological treatment including Electroconvulsive Therapy (ECT), Vagus Nerve Stimulation (VNS), or Repetitive Transcranial Magnetic Stimulation (RTMS)
• Past or present psychotic symptoms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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357 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

RO4995819 15 mg

Experimental group

Treatment:

Drug: RO4995819

Drug: RO4995819

Drug: RO4995819

RO4995819 30 mg

Experimental group

Treatment:

Drug: RO4995819

Drug: RO4995819

Drug: RO4995819

RO4995819 5 mg

Experimental group

Treatment:

Drug: RO4995819

Drug: RO4995819

Drug: RO4995819