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

NCT01457677 | Completed Phase 2

• 1 other identifier: BP25712
• Study Type: interventional
• Target: 357
• Locations: 8 countries
• Sites: 92

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (3)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

RO4995819 15 mg

EXPERIMENTAL

Drug: RO4995819

RO4995819 30 mg

EXPERIMENTAL

Drug: RO4995819

RO4995819 5 mg

EXPERIMENTAL

Drug: RO4995819

Interventions

Placebo DRUG

matching placebo to RO4995819 oral once daily for 6 weeks

Placebo

RO4995819 DRUG

5 mg oral once daily for 6 weeks

RO4995819 5 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (92)

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Phoenix, Arizona, 85381, United States

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Oakland, California, 94607, United States

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Redlands, California, 92374, United States

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San Diego, California, 92103, United States

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Stanford, California, 94305, United States

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Torrance, California, 90502, United States

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Victorville, California, 92295, United States

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Denver, Colorado, 80239, United States

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Coral Springs, Florida, 33067, United States

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Gainsville, Florida, 32607, United States

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Jacksonville, Florida, 32216, United States

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Lauderhill, Florida, 33319, United States

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North Miami, Florida, 33161, United States

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Ocala, Florida, 34471, United States

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Atlanta, Georgia, 30308, United States

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Roswell, Georgia, 30076, United States

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Smyrna, Georgia, 30080, United States

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Chicago, Illinois, 60612-3244, United States

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Prairie Village, Kansas, 66206, United States

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Wichita, Kansas, 67214, United States

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Baltimore, Maryland, 21208, United States

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Boston, Massachusetts, 02114, United States

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Watertown, Massachusetts, 02472, United States

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Flowood, Mississippi, 39232, United States

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O'Fallon, Missouri, 63368, United States

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Albuquerque, New Mexico, 87131, United States

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New York, New York, 10021, United States

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New York, New York, 10029, United States

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New York, New York, 10032, United States

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Rochester, New York, 14618, United States

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Durham, North Carolina, 27710, United States

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Beachwood, Ohio, 44122, United States

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Canton, Ohio, 44718, United States

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Cincinnati, Ohio, 45215, United States

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Cincinnati, Ohio, 45227, United States

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Jenkintown, Pennsylvania, 19046, United States

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Media, Pennsylvania, 19063, United States

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Columbia, South Carolina, 29201, United States

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Arlington, Texas, 76012, United States

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Houston, Texas, 77030, United States

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Salt Lake City, Utah, 84106, United States

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Richmond, Virginia, 23298, United States

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Roanoke, Virginia, 24014, United States

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Innsbruck, 6020, Austria

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Vienna, 1090, Austria

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Wien, Vienna, 1090, Austria

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Kentville, Nova Scotia, B4N 4K9, Canada

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Kingston, Ontario, K7L 4X3, Canada

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Ottowa, Ontario, K1Z 7K4, Canada

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Gatineau, Quebec, J9A 1k7, Canada

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Sherbrooke, Quebec, J1H 4J6, Canada

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Verdun, Quebec, H4H 1R3, Canada

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Ellwangen, 73479, Germany

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Leipzig, 04275, Germany

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Mannheim, 68159, Germany

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Nuremberg, 90402, Germany

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Oranienburg, 16515, Germany

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Ostfildern, 73760, Germany

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Schwerin, Mecklenburg-Vorpommern, 19053, Germany

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Lipetsk, 399083, Russia

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Moscow, 117105, Russia

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Moscow, 117995, Russia

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Novosibirsk, 630091, Russia

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Saint Petersburg, 190121, Russia

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Saint Petersburg, 191119, Russia

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Saint Petersburg, 192019, Russia

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Saint Petersburg, 199004, Russia

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Samara, 443016, Russia

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Smolensk, 214019, Russia

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Talagi, 163530, Russia

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Tomsk, 634014, Russia

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Yaroslavl, 150003, Russia

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Yekaterinburg, 620030, Russia

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Yekaterinburg, 620036, Russia

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Bratislava, 811 07, Slovakia

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Bratislava, 813 69, Slovakia

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Bratislava, 851 01, Slovakia

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Rimavská Sobota, 979 01, Slovakia

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Trenčín, 911 01, Slovakia

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Bellville, Cape Town, 7530, South Africa

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Cape Town, Western Cape, 7130, South Africa

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Cape Town, Western CAPE, 7925, South Africa

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Centurion, Pretoria, 0046, South Africa

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Nieu Muckleneuk, Pretoria, 0181, South Africa

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Dnipropetrovsk, 49005, Ukraine

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Donetsk, 83008, Ukraine

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Kharkiv, 61068, Ukraine

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Kherson,Vil. Stepanivka, 73488, Ukraine

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Kiev, 02660, Ukraine

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Odesa, 65006, Ukraine

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Simferopol, Crimea, 95006, Ukraine

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Vinnytsia, 21005, Ukraine

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Related Publications (2)

• 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.

  PMID: 34510411 DERIVED

• 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.

  PMID: 32663909 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 24, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CA (6); DE (7); SL (5); UA (8); AU (3); RU (15); ZA (5); US (43)