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)

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: RO4995819; Drug: RO4995819; Drug: RO4995819

• Study Type: Interventional
• Enrollment (Actual): 357
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
  • Wien, Austria, 1090
  • Wien, Vienna, Austria, 1090
• Canada
  • Nova Scotia
    • Kentville,, Nova Scotia, Canada, B4N 4K9
  • Ontario
    • Kingston, Ontario, Canada, K7L 4X3
    • Ottowa, Ontario, Canada, K1Z 7K4
  • Quebec
    • Gatineau, Quebec, Canada, J9A 1k7
    • Sherbrooke, Quebec, Canada, J1H 4J6
    • Verdun, Quebec, Canada, H4H 1R3
• Germany
  • Ellwangen, Germany, 73479
  • Leipzig, Germany, 04275
  • Mannheim, Germany, 68159
  • Nürnberg, Germany, 90402
  • Oranienburg, Germany, 16515
  • Ostfildern, Germany, 73760
  • Schwerin, Mecklenburg-Vorpommern, Germany, 19053
• Russian Federation
  • Ekaterinburg, Russian Federation, 620036
  • Ekaterinburg, Russian Federation, 620030
  • Lipetsk, Russian Federation, 399083
  • Moscow, Russian Federation, 117995
  • Moscow, Russian Federation, 117105
  • Novosibirsk, Russian Federation, 630091
  • Saint Petersburg, Russian Federation, 191119
  • Samara, Russian Federation, 443016
  • Smolensk, Russian Federation, 214019
  • St Petersburg, Russian Federation, 192019
  • St. Petersburg, Russian Federation, 190121
  • St. Petersburg, Russian Federation, 199004
  • Talagi, Russian Federation, 163530
  • Tomsk, Russian Federation, 634014
  • Yaroslavl, Russian Federation, 150003
• Slovakia
  • Bratislava, Slovakia, 851 01
  • Bratislava, Slovakia, 811 07
  • Bratislava, Slovakia, 813 69
  • Rimavska Sobota, Slovakia, 979 01
  • Trencin, Slovakia, 911 01
• South Africa
  • Bellville, Cape Town, South Africa, 7530
  • Cape Town, WESTERN CAPE, South Africa, 7925
  • Cape Town, Western Cape, South Africa, 7130
  • Centurion, Pretoria, South Africa, 0046
  • Nieu Muckleneuk, Pretoria, South Africa, 0181
• Ukraine
  • Dnipropetrovsk, Ukraine, 49005
  • Donetsk, Ukraine, 83008
  • Kharkiv, Ukraine, 61068
  • Kherson,Vil. Stepanivka, Ukraine, 73488
  • Kiev, Ukraine, 02660
  • Odessa, Ukraine, 65006
  • Simferopol, Crimea, Ukraine, 95006
  • Vinnytsya, Ukraine, 21005
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85381
  • California
    • Oakland, California, United States, 94607
    • Redlands, California, United States, 92374
    • San Diego, California, United States, 92103
    • Stanford, California, United States, 94305
    • Torrance, California, United States, 90502
    • Victorville, California, United States, 92295
  • Colorado
    • Denver, Colorado, United States, 80239
  • Florida
    • Coral Springs, Florida, United States, 33067
    • Gainsville, Florida, United States, 32607
    • Jacksonville, Florida, United States, 32216
    • Lauderhill, Florida, United States, 33319
    • North Miami, Florida, United States, 33161
    • Ocala, Florida, United States, 34471
  • Georgia
    • Atlanta, Georgia, United States, 30308
    • Roswell, Georgia, United States, 30076
    • Smyrna, Georgia, United States, 30080
  • Illinois
    • Chicago, Illinois, United States, 60612-3244
  • Kansas
    • Prairie Village, Kansas, United States, 66206
    • Wichita, Kansas, United States, 67214
  • Maryland
    • Baltimore, Maryland, United States, 21208
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
    • Watertown, Massachusetts, United States, 02472
  • Mississippi
    • Flowood, Mississippi, United States, 39232
  • Missouri
    • O'Fallon, Missouri, United States, 63368
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
  • New York
    • New York, New York, United States, 10032
    • New York, New York, United States, 10021
    • New York, New York, United States, 10029
    • Rochester, New York, United States, 14618
  • North Carolina
    • Durham, North Carolina, United States, 27710
  • Ohio
    • Beachwood, Ohio, United States, 44122
    • Canton, Ohio, United States, 44718
    • Cincinnati, Ohio, United States, 45227
    • Cincinnati, Ohio, United States, 45215
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
    • Media, Pennsylvania, United States, 19063
  • South Carolina
    • Columbia, South Carolina, United States, 29201
  • Texas
    • Arlington, Texas, United States, 76012
    • Houston, Texas, United States, 77030
  • Utah
    • Salt Lake City, Utah, United States, 84106
  • Virginia
    • Richmond, Virginia, United States, 23298
    • Roanoke, Virginia, United States, 24014

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; matching placebo to RO4995819 oral once daily for 6 weeks
Experimental: RO4995819 15 mg	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
Experimental: RO4995819 30 mg	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
Experimental: RO4995819 5 mg	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
• Umbricht D, Niggli M, Sanwald-Ducray P, Deptula D, Moore R, Grunbauer W, Boak L, Fontoura P. Randomized, Double-Blind, Placebo-Controlled Trial of the mGlu2/3 Negative Allosteric Modulator Decoglurant in Partially Refractory Major Depressive Disorder. J Clin Psychiatry. 2020 Jul 14;81(4):18m12470. doi: 10.4088/JCP.18m12470.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: October 20, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 24, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: BP25712