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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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01437657
Collaborator
(none)
319
Enrollment
76
Locations
3
Arms
23
Duration (Months)
4.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: RO4917523 0.5 mg
  • Drug: RO4917523 1.5 mg
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
319 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Matching RO4917523 placebo orally daily, 6 weeks

Drug: Placebo
Matching RO4917523 placebo orally daily, 6 weeks
Experimental: RO4917523 0.5 mg

0.5 mg orally daily, 6 weeks

Drug: RO4917523 0.5 mg
0.5 mg orally daily, 6 weeks
Experimental: RO4917523 1.5 mg

1.5 mg orally daily, 6 weeks

Drug: RO4917523 1.5 mg
1.5 mg orally daily, 6 weeks

Outcome Measures

Primary Outcome Measures

  1. Change in Montgomery Asberg Depression Rating Scale (MADRS) [From baseline to Week 6]

Secondary Outcome Measures

  1. Change in Clinical Global Impression Score - Severity (CGI-S) [From baseline to Week 6]

  2. Change in Clinical Global Impression Score - Improvement (CGI-I) [From baseline to Week 6]

  3. Safety: Incidence of adverse events [approximately 2 years]

  4. Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment [approximately 2 years]

  5. Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment [approximately 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Little Rock Arkansas United States 72223
2 Costa Mesa California United States 92626
3 Garden Grove California United States 92845
4 Oceanside California United States 92056
5 Orange California United States 92868
6 Riverside California United States 92506
7 San Diego California United States 92102
8 San Diego California United States 92103
9 San Diego California United States 92121
10 Santa Ana California United States 92705
11 Wildomar California United States 92595
12 Atlanta Georgia United States 30328
13 Libertyville Illinois United States 60048
14 Naperville Illinois United States 60563
15 Oak Brook Illinois United States 60523
16 Shreveport Louisiana United States 71115
17 Baltimore Maryland United States 21285
18 Las Vegas Nevada United States 89102
19 Marlton New Jersey United States 08053
20 Brooklyn New York United States 11201
21 Cedarhurst New York United States 11516
22 Oklahoma City Oklahoma United States 73112
23 Norristown Pennsylvania United States 19403
24 Philadelphia Pennsylvania United States 19104
25 Philadelphia Pennsylvania United States 19139
26 Pittsburgh Pennsylvania United States 15213
27 Memphis Tennessee United States 38119
28 Kirkland Washington United States 98033
29 Santiago Chile 7500710
30 Santiago Chile 7580307
31 Temuco Chile 4781151
32 Berlin Germany 10117
33 Berlin Germany 12203
34 Freiburg Germany 79104
35 Hannover Germany 30159
36 Mainz Germany 55131
37 Wiesbaden Germany 65185
38 Chuo-ku Japan 260-8670
39 Hokkaido Japan 060-8648
40 Hyogo Japan 659-0093
41 Kanagawa Japan 216-8511
42 Kanagawa Japan 252-0303
43 Kita-Ku Japan 114-0024
44 Kurayoshi-shi Japan 682-0023
45 Kyoto Japan 618-8421
46 Osaka Japan 569-1041
47 Shinjuku-ku Japan 160-8582
48 Tokyo Japan 100-0006
49 Tokyo Japan 107-0052
50 Tokyo Japan 151-0053
51 Tokyo Japan 157-8577
52 Tokyo Japan 162-0821
53 Tokyo Japan 162-8666
54 Tokyo Japan 170-0002
55 Tokyo Japan 187-8551
56 Aguascalientes Mexico 20127
57 Leon Mexico 37000
58 Monterrey Mexico 64060
59 Belchatow Poland 97-400
60 Bialystok Poland 15-464
61 Bialystok Poland 15-879
62 Choroszcz Poland 16-070
63 Kielce Poland 25-411
64 Lodz Poland 91-229
65 Tuszyn Poland 95-080
66 Bucuresti Romania 030442
67 Bucuresti Romania 031723
68 Constanta Romania 900002
69 Craiova Romania 200620
70 Targouiste Romania 130086
71 Targu Mures Romania 540139
72 St. Petersburg Russian Federation 190121
73 St. Petersburg Russian Federation 192019
74 Keelung Taiwan 20445
75 Taichung Taiwan 40447
76 Taipei Taiwan 00112

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01437657
Other Study ID Numbers:
  • NP25620
  • 2011-001436-33
First Posted:
Sep 21, 2011
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major

Study Results

No Results Posted as of Nov 2, 2016