Clinical trial NCT01457677: ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant Treatment
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety (incidence of a adverse events)
timeFrame: 6 weeks
measure: Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10)
timeFrame: 6 weeks
measure: Proportion of patients exhibiting response based on the Montgomery Asberg Depression Rating Scale (MADRS) (reduction in score of >/= 50% of the baseline score)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Oakland
country: United States
state: California
city: Redlands
country: United States
state: California
city: San Diego
country: United States
state: California
city: Stanford
country: United States
state: California
city: Torrance
country: United States
state: California
city: Victorville
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Coral Springs
country: United States
state: Florida
city: Gainsville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lauderhill
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Smyrna
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Prairie Village
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Watertown
country: United States
state: Massachusetts
city: Flowood
country: United States
state: Mississippi
city: O'Fallon
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Beachwood
country: United States
state: Ohio
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Jenkintown
country: United States
state: Pennsylvania
city: Media
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Arlington
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Innsbruck
country: Austria
city: Wien, Vienna
country: Austria
city: Wien
country: Austria
city: Kentville,
country: Canada
state: Nova Scotia
city: Kingston
country: Canada
state: Ontario
city: Ottowa
country: Canada
state: Ontario
city: Gatineau
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Verdun
country: Canada
state: Quebec
city: Ellwangen
country: Germany
city: Leipzig
country: Germany
city: Mannheim
country: Germany
city: Nürnberg
country: Germany
city: Oranienburg
country: Germany
city: Ostfildern
country: Germany
city: Schwerin, Mecklenburg-Vorpommern
country: Germany
city: Ekaterinburg
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Lipetsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Talagi
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Trencin
country: Slovakia
city: Bellville, Cape Town
country: South Africa
city: Cape Town, Western Cape
country: South Africa
city: Cape Town, WESTERN CAPE
country: South Africa
city: Centurion, Pretoria
country: South Africa
city: Nieu Muckleneuk, Pretoria
country: South Africa
city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson,Vil. Stepanivka
country: Ukraine
city: Kiev
country: Ukraine
city: Odessa
country: Ukraine
city: Simferopol, Crimea
country: Ukraine
city: Vinnytsya
country: Ukraine
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.