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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
RO4995819
RO4995819
RO4995819
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

RO4995819 15 mg

RO4995819 30 mg

RO4995819 5 mg

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety (incidence of a adverse events)
Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10)
Proportion of patients exhibiting response based on the Montgomery Asberg Depression Rating Scale (MADRS) (reduction in score of >/= 50% of the baseline score)

Full Information

First Posted
October 20, 2011
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01457677
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
RO4995819 15 mg
Arm Type
Experimental
Arm Title
RO4995819 30 mg
Arm Type
Experimental
Arm Title
RO4995819 5 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo to RO4995819 oral once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
RO4995819
Intervention Description
5 mg oral once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
RO4995819
Intervention Description
15 mg oral once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
RO4995819
Intervention Description
30 mg oral once daily for 6 weeks
Primary Outcome Measure Information:
Title
Mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Safety (incidence of a adverse events)
Time Frame
6 weeks
Title
Proportion of patients exhibiting remission based on the Montgomery Asberg Depression Rating Scale (MADRS) (score of </=10)
Time Frame
6 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Victorville
State/Province
California
ZIP/Postal Code
92295
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3244
Country
United States
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Wien, Vienna
ZIP/Postal Code
1090
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Kentville,
State/Province
Nova Scotia
ZIP/Postal Code
B4N 4K9
Country
Canada
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 4X3
Country
Canada
City
Ottowa
State/Province
Ontario
ZIP/Postal Code
K1Z 7K4
Country
Canada
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J9A 1k7
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4J6
Country
Canada
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
City
Ellwangen
ZIP/Postal Code
73479
Country
Germany
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
City
Nürnberg
ZIP/Postal Code
90402
Country
Germany
City
Oranienburg
ZIP/Postal Code
16515
Country
Germany
City
Ostfildern
ZIP/Postal Code
73760
Country
Germany
City
Schwerin, Mecklenburg-Vorpommern
ZIP/Postal Code
19053
Country
Germany
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
City
Ekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
City
Lipetsk
ZIP/Postal Code
399083
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117105
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117995
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
City
Saint Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
199004
Country
Russian Federation
City
Talagi
ZIP/Postal Code
163530
Country
Russian Federation
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
City
Bratislava
ZIP/Postal Code
811 07
Country
Slovakia
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
City
Bellville, Cape Town
ZIP/Postal Code
7530
Country
South Africa
City
Cape Town, Western Cape
ZIP/Postal Code
7130
Country
South Africa
City
Cape Town, WESTERN CAPE
ZIP/Postal Code
7925
Country
South Africa
City
Centurion, Pretoria
ZIP/Postal Code
0046
Country
South Africa
City
Nieu Muckleneuk, Pretoria
ZIP/Postal Code
0181
Country
South Africa
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
City
Kherson,Vil. Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
City
Kiev
ZIP/Postal Code
02660
Country
Ukraine
City
Odessa
ZIP/Postal Code
65006
Country
Ukraine
City
Simferopol, Crimea
ZIP/Postal Code
95006
Country
Ukraine
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
34510411
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.
Results Reference
derived
PubMed Identifier
32663909
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.
Results Reference
derived

Learn more about this trial

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

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