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)

Hoffmann-La Roche0 sites357 target enrollmentDecember 2011

ConditionsMajor Depressive Disorder

InterventionsPlacebo RO4995819

DrugsPlacebo RO4995819

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Major Depressive Disorder
Sponsor: Hoffmann-La Roche
Enrollment: 357
Primary Endpoint: Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

June 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Placebo

Intervention: Placebo

RO4995819 15 mg

Intervention: RO4995819

RO4995819 30 mg

Intervention: RO4995819

RO4995819 5 mg

Intervention: RO4995819

Outcomes

Primary Outcomes

Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores

Time Frame: 6 weeks

Secondary Outcomes

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)