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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi Center, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Investigate the Efficacy and Safety of RO4995819 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder Having Inadequate Response to Ongoing Antidepressant Treatment (ARTDeCo)

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Placebo
* Drug: RO4995819
* Drug: RO4995819
* Drug: RO4995819


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* matching placebo to RO4995819 oral once daily for 6 weeks<br>|
| Experimental: RO4995819 15 mg<br> | Drug: RO4995819<br>* 15 mg oral once daily for 6 weeks<br>|
| Experimental: RO4995819 30 mg<br> | Drug: RO4995819<br>* 30 mg oral once daily for 6 weeks<br>|
| Experimental: RO4995819 5 mg<br> | Drug: RO4995819<br>* 5 mg oral once daily for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (incidence of a adverse events) |  | 6 weeks | 
| Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10) |  | 6 weeks | 
| Proportion of patients exhibiting response based on the Montgomery Asberg Depression Rating Scale (MADRS) (reduction in score of >/= 50% of the baseline score) |  | 6 weeks |