ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant Treatment
NCT ID: NCT01457677
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
357 participants
INTERVENTIONAL
2011-12-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
matching placebo to RO4995819 oral once daily for 6 weeks
RO4995819 15 mg
RO4995819
15 mg oral once daily for 6 weeks
RO4995819 30 mg
RO4995819
30 mg oral once daily for 6 weeks
RO4995819 5 mg
RO4995819
5 mg oral once daily for 6 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Phoenix, Arizona, United States
Oakland, California, United States
Redlands, California, United States
San Diego, California, United States
Stanford, California, United States
Torrance, California, United States
Victorville, California, United States
Denver, Colorado, United States
Coral Springs, Florida, United States
Gainsville, Florida, United States
Jacksonville, Florida, United States
Lauderhill, Florida, United States
North Miami, Florida, United States
Ocala, Florida, United States
Atlanta, Georgia, United States
Roswell, Georgia, United States
Smyrna, Georgia, United States
Chicago, Illinois, United States
Prairie Village, Kansas, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Watertown, Massachusetts, United States
Flowood, Mississippi, United States
O'Fallon, Missouri, United States
Albuquerque, New Mexico, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Durham, North Carolina, United States
Beachwood, Ohio, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Jenkintown, Pennsylvania, United States
Media, Pennsylvania, United States
Columbia, South Carolina, United States
Arlington, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Innsbruck, , Austria
Vienna, , Austria
Wien, Vienna, , Austria
Kentville, Nova Scotia, Canada
Kingston, Ontario, Canada
Ottowa, Ontario, Canada
Gatineau, Quebec, Canada
Sherbrooke, Quebec, Canada
Verdun, Quebec, Canada
Ellwangen, , Germany
Leipzig, , Germany
Mannheim, , Germany
Nuremberg, , Germany
Oranienburg, , Germany
Ostfildern, , Germany
Schwerin, Mecklenburg-Vorpommern, , Germany
Lipetsk, , Russia
Moscow, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Smolensk, , Russia
Talagi, , Russia
Tomsk, , Russia
Yaroslavl, , Russia
Yekaterinburg, , Russia
Yekaterinburg, , Russia
Bratislava, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Rimavská Sobota, , Slovakia
Trenčín, , Slovakia
Bellville, Cape Town, , South Africa
Cape Town, Western Cape, , South Africa
Cape Town, Western CAPE, , South Africa
Centurion, Pretoria, , South Africa
Nieu Muckleneuk, Pretoria, , South Africa
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kherson,Vil. Stepanivka, , Ukraine
Kiev, , Ukraine
Odesa, , Ukraine
Simferopol, Crimea, , Ukraine
Vinnytsia, , Ukraine
Countries
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References
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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.
Other Identifiers
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BP25712
Identifier Type: -
Identifier Source: org_study_id