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

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01457677

Run by

Hoffmann-La Roche

People needed

357

Starts

2011-12-01

Expected to finish

2014-06-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Oakland, California, United States
• Study site — Redlands, California, United States
• Study site — San Diego, California, United States
• Study site — Stanford, California, United States
• Study site — Torrance, California, United States
• Study site — Victorville, California, United States
• Study site — Denver, Colorado, United States
• Study site — Coral Springs, Florida, United States
• Study site — Gainsville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Lauderhill, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Roswell, Georgia, United States
• Study site — Smyrna, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Prairie Village, Kansas, United States
• Study site — Wichita, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Watertown, Massachusetts, United States
• Study site — Flowood, Mississippi, United States
• Study site — O'Fallon, Missouri, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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