Status:
COMPLETED
ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant Treatment
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 diso...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT01457677
Start Date
December 1 2011
End Date
June 1 2014
Last Update
November 2 2016
Active Locations (92)
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1
Phoenix, Arizona, United States, 85381
2
Oakland, California, United States, 94607
3
Redlands, California, United States, 92374
4
San Diego, California, United States, 92103