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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: RO4995819

• Registration Number: NCT01457677
• Lead Sponsor: Hoffmann-La Roche

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-20
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-24
• Study Start: 2011-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Disposition First Submitted: 2016-07-08
• Disposition First Submitted QC: 2016-07-08
• Disposition First Posted: 2016-07-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
RO4995819 30 mg	RO4995819	-
RO4995819 15 mg	RO4995819	-
RO4995819 5 mg	RO4995819	-

Primary Outcome Measures

Name	Time	Method
Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores	6 weeks

Secondary Outcome Measures

Name	Time	Method
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