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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01457677

Enrollment

357

Registered

2011-10-24

Start date

2011-12-31

Completion date

2014-06-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

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.

Interventions

DRUGPlacebo

matching placebo to RO4995819 oral once daily for 6 weeks

DRUGRO4995819

5 mg oral once daily for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores	6 weeks

Secondary

Measure	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

Countries

Austria, Canada, Germany, Russia, Slovakia, South Africa, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026