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

This study is currently recruiting participants.

Verified September 2012 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01457677

First received: October 20, 2011

Last updated: September 19, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 20, 2011

Last Updated Date

September 19, 2012

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01457677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety (incidence of a adverse events) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Proportion of patients exhibiting response based on the Montgomery Asberg Depression Rating Scale (MADRS) (reduction in score of >/= 50% of the baseline score) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Depression Disorder, Major

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Intervention: Drug: RO4995819
Experimental: 2
Intervention: Drug: RO4995819
Experimental: 3
Intervention: Drug: RO4995819
Placebo Comparator: 4
Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

480

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: BP25712 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT01457677

Other Study ID Numbers ^ICMJE

BP25712

Has Data Monitoring Committee

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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