search
Back to results

MARIGOLD Study: A Study of RO4917523 Versus Placebo as Adjunctive Therapy in Patients With Major Depressive Disorder and an Inadequate Response to Ongoing Antidepressant Therapy

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
RO4917523 0.5 mg
RO4917523 1.5 mg
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 - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patient, 18 to 70 years of age at time of informed consent
  • Major depressive disorder without psychotic features as defined by DSM-IV-TR criteria
  • Inadequate response to ongoing antidepressant treatment, as defined by protocol
  • Body mass index (BMI) 18 to 38 kg/m2 inclusive

Exclusion Criteria:

  • Currently receiving treatment with a combination of antidepressants (two or more), or an adjunctive potentiating treatment as defined by protocol
  • Previously received RO4917523
  • History of failure, or utilization during the current episode of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)
  • History of use at any time of Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation (DBS)
  • Current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed episodes)
  • Pregnant or lactating women

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

RO4917523 0.5 mg

RO4917523 1.5 mg

Arm Description

Matching RO4917523 placebo orally daily, 6 weeks

0.5 mg orally daily, 6 weeks

1.5 mg orally daily, 6 weeks

Outcomes

Primary Outcome Measures

Change in Montgomery Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Change in Clinical Global Impression Score - Severity (CGI-S)
Change in Clinical Global Impression Score - Improvement (CGI-I)
Safety: Incidence of adverse events
Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment
Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment

Full Information

First Posted
September 20, 2011
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT01437657
Brief Title
MARIGOLD Study: A Study of RO4917523 Versus Placebo as Adjunctive Therapy in Patients With Major Depressive Disorder and an Inadequate Response to Ongoing Antidepressant Therapy
Official Title
A Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of RO4917523 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder With Inadequate Response to Ongoing Antidepressant Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (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 randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on study treatment is 6 weeks with a 3-week follow-up.

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
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching RO4917523 placebo orally daily, 6 weeks
Arm Title
RO4917523 0.5 mg
Arm Type
Experimental
Arm Description
0.5 mg orally daily, 6 weeks
Arm Title
RO4917523 1.5 mg
Arm Type
Experimental
Arm Description
1.5 mg orally daily, 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching RO4917523 placebo orally daily, 6 weeks
Intervention Type
Drug
Intervention Name(s)
RO4917523 0.5 mg
Intervention Description
0.5 mg orally daily, 6 weeks
Intervention Type
Drug
Intervention Name(s)
RO4917523 1.5 mg
Intervention Description
1.5 mg orally daily, 6 weeks
Primary Outcome Measure Information:
Title
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame
From baseline to Week 6
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression Score - Severity (CGI-S)
Time Frame
From baseline to Week 6
Title
Change in Clinical Global Impression Score - Improvement (CGI-I)
Time Frame
From baseline to Week 6
Title
Safety: Incidence of adverse events
Time Frame
approximately 2 years
Title
Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment
Time Frame
approximately 2 years
Title
Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment
Time Frame
approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patient, 18 to 70 years of age at time of informed consent Major depressive disorder without psychotic features as defined by DSM-IV-TR criteria Inadequate response to ongoing antidepressant treatment, as defined by protocol Body mass index (BMI) 18 to 38 kg/m2 inclusive Exclusion Criteria: Currently receiving treatment with a combination of antidepressants (two or more), or an adjunctive potentiating treatment as defined by protocol Previously received RO4917523 History of failure, or utilization during the current episode of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS) History of use at any time of Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation (DBS) Current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed episodes) Pregnant or lactating women
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
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72223
Country
United States
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71115
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
City
Santiago
ZIP/Postal Code
7580307
Country
Chile
City
Temuco
ZIP/Postal Code
4781151
Country
Chile
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Berlin
ZIP/Postal Code
12203
Country
Germany
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
City
Hannover
ZIP/Postal Code
30159
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Wiesbaden
ZIP/Postal Code
65185
Country
Germany
City
Chuo-ku
ZIP/Postal Code
260-8670
Country
Japan
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
City
Hyogo
ZIP/Postal Code
659-0093
Country
Japan
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
City
Kanagawa
ZIP/Postal Code
252-0303
Country
Japan
City
Kita-Ku
ZIP/Postal Code
114-0024
Country
Japan
City
Kurayoshi-shi
ZIP/Postal Code
682-0023
Country
Japan
City
Kyoto
ZIP/Postal Code
618-8421
Country
Japan
City
Osaka
ZIP/Postal Code
569-1041
Country
Japan
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
City
Tokyo
ZIP/Postal Code
100-0006
Country
Japan
City
Tokyo
ZIP/Postal Code
107-0052
Country
Japan
City
Tokyo
ZIP/Postal Code
151-0053
Country
Japan
City
Tokyo
ZIP/Postal Code
157-8577
Country
Japan
City
Tokyo
ZIP/Postal Code
162-0821
Country
Japan
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
City
Tokyo
ZIP/Postal Code
170-0002
Country
Japan
City
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
City
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
City
Leon
ZIP/Postal Code
37000
Country
Mexico
City
Monterrey
ZIP/Postal Code
64060
Country
Mexico
City
Belchatow
ZIP/Postal Code
97-400
Country
Poland
City
Bialystok
ZIP/Postal Code
15-464
Country
Poland
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
City
Choroszcz
ZIP/Postal Code
16-070
Country
Poland
City
Kielce
ZIP/Postal Code
25-411
Country
Poland
City
Lodz
ZIP/Postal Code
91-229
Country
Poland
City
Tuszyn
ZIP/Postal Code
95-080
Country
Poland
City
Bucuresti
ZIP/Postal Code
030442
Country
Romania
City
Bucuresti
ZIP/Postal Code
031723
Country
Romania
City
Constanta
ZIP/Postal Code
900002
Country
Romania
City
Craiova
ZIP/Postal Code
200620
Country
Romania
City
Targouiste
ZIP/Postal Code
130086
Country
Romania
City
Targu Mures
ZIP/Postal Code
540139
Country
Romania
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
City
Keelung
ZIP/Postal Code
20445
Country
Taiwan
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27304433
Citation
Quiroz JA, Tamburri P, Deptula D, Banken L, Beyer U, Rabbia M, Parkar N, Fontoura P, Santarelli L. Efficacy and Safety of Basimglurant as Adjunctive Therapy for Major Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jul 1;73(7):675-84. doi: 10.1001/jamapsychiatry.2016.0838.
Results Reference
derived

Learn more about this trial

MARIGOLD Study: A Study of RO4917523 Versus Placebo as Adjunctive Therapy in Patients With Major Depressive Disorder and an Inadequate Response to Ongoing Antidepressant Therapy

We'll reach out to this number within 24 hrs