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

Major Depressive Disorder Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457677
• Other study ID #: BP25712
• Status: Completed
• Phase: Phase 2
• First received: October 20, 2011
• Last updated: November 1, 2016
• Start date: December 2011
• Est. completion date: June 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Placebo
matching placebo to RO4995819 oral once daily for 6 weeks
• RO4995819
5 mg oral once daily for 6 weeks
• RO4995819
15 mg oral once daily for 6 weeks
• RO4995819
30 mg oral once daily for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Germany,  Russian Federation,  Slovakia,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores		6 weeks	No
Secondary	Safety (incidence of a adverse events)		6 weeks	No
Secondary	Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10)		6 weeks	No
Secondary	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	No