A Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of RO4917523 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder With Inadequate Response to Ongoing Antidepressant Treatment

Hoffmann-La Roche0 sites319 target enrollmentOctober 2011

ConditionsMajor Depressive Disorder

InterventionsPlacebo RO4917523 0.5 mg RO4917523 1.5 mg

DrugsPlacebo RO4917523 0.5 mg RO4917523 1.5 mg

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Major Depressive Disorder
Sponsor: Hoffmann-La Roche
Enrollment: 319
Primary Endpoint: Change in Montgomery Asberg Depression Rating Scale (MADRS)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on study treatment is 6 weeks with a 3-week follow-up.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

September 2013

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 patient, 18 to 70 years of age at time of informed consent
•Major depressive disorder without psychotic features as defined by DSM-IV-TR criteria
•Inadequate response to ongoing antidepressant treatment, as defined by protocol
•Body mass index (BMI) 18 to 38 kg/m2 inclusive

Exclusion Criteria

•Currently receiving treatment with a combination of antidepressants (two or more), or an adjunctive potentiating treatment as defined by protocol
•Previously received RO4917523
•History of failure, or utilization during the current episode of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)
•History of use at any time of Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation (DBS)
•Current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed episodes)
•Pregnant or lactating women

Arms & Interventions

Placebo

Matching RO4917523 placebo orally daily, 6 weeks

Intervention: Placebo

RO4917523 0.5 mg

0.5 mg orally daily, 6 weeks

Intervention: RO4917523 0.5 mg

RO4917523 1.5 mg

1.5 mg orally daily, 6 weeks

Intervention: RO4917523 1.5 mg

Outcomes

Primary Outcomes

Change in Montgomery Asberg Depression Rating Scale (MADRS)

Time Frame: From baseline to Week 6

Secondary Outcomes

Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment(approximately 2 years)
Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment(approximately 2 years)
Safety: Incidence of adverse events(approximately 2 years)
Change in Clinical Global Impression Score - Severity (CGI-S)(From baseline to Week 6)
Change in Clinical Global Impression Score - Improvement (CGI-I)(From baseline to Week 6)