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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01437657
First received: September 20, 2011
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Depression Disorder, Major
Drug: RO4917523
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: From baseline to Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Clinical Global Impression Score - Severity (CGI-S) [ Time Frame: From baseline to Week 6 ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression Score - Improvement (CGI-I) [ Time Frame: From baseline to Week 6 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Enrollment: 318
Study Start Date: October 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: RO4917523
0.5 mg orally daily, 6 weeks
Experimental: B Drug: RO4917523
1.5 mg orally daily, 6 weeks
Placebo Comparator: C Drug: Placebo
matching RO4917523 placebo orally daily, 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437657

  Hide Study Locations
Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72223
United States, California
Costa Mesa, California, United States, 92626
Garden Grove, California, United States, 92845
Oceanside, California, United States, 92056
Riverside, California, United States, 92506
San Diego, California, United States, 92121
San Diego, California, United States, 92102
Santa Ana, California, United States, 92705
Santa Ana, California, United States, 92701
Wildomar, California, United States, 92595
United States, Georgia
Atlanta, Georgia, United States, 30328
United States, Illinois
Libertyville, Illinois, United States, 60048
Oak Brook, Illinois, United States, 60523
United States, Louisiana
Shreveport, Louisiana, United States, 71115
United States, Maryland
Baltimore, Maryland, United States, 21285
United States, Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Marlton, New Jersey, United States, 08053
United States, New York
Brooklyn, New York, United States, 11201
Cedarhurst, New York, United States, 11516
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19139
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Memphis, Tennessee, United States, 38119
Chile
Santiago, Chile, 7500710
Santiago, Chile, 7580307
Temuco, Chile, 4781151
Germany
Berlin, Germany, 14050
Berlin, Germany, 10117
Freiburg, Germany, 79104
Hannover, Germany, 30159
Mainz, Germany, 55131
Wiesbaden, Germany, 65185
Japan
Chuo-ku, Japan, 260-8670
Hokkaido, Japan, 060-8648
Hyogo, Japan, 659-0093
Kanagawa, Japan, 252-0303
Kanagawa, Japan, 216-8511
Kita-Ku, Japan, 114-0024
Kurayoshi-shi, Japan, 682-0023
Kyoto, Japan, 618-8421
Osaka, Japan, 569-1041
Shinjuku-ku, Japan, 162-8666
Shinjuku-ku, Japan, 160-8582
Tokyo, Japan, 151-0053
Tokyo, Japan, 107-0052
Tokyo, Japan, 170-0002
Tokyo, Japan, 100-0006
Tokyo, Japan, 187-8551
Tokyo, Japan, 157-8577
Tokyo, Japan, 162-0821
Mexico
Aguascalientes, Mexico, 20127
Leon, Mexico, 37000
Monterrey, Mexico, 64060
Poland
Belchatow, Poland, 97-400
Bialystok, Poland, 15-464
Bialystok, Poland, 15-879
Choroszcz, Poland, 16-070
Kielce, Poland, 25-411
Lodz, Poland, 91-229
Tuszyn, Poland, 95-080
Romania
Bucuresti, Romania, 031723
Bucuresti, Romania, 030442
Constanta, Romania, 900002
Craiova, Romania, 200620
Targouiste, Romania, 130086
Targu Mures, Romania, 540139
Russian Federation
St. Petersburg, Russian Federation, 192019
St. Petersburg, Russian Federation, 190121
Taiwan
Keelung, Taiwan, 20445
Taichung, Taiwan, 40447
Taipei, Taiwan, 00112
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01437657     History of Changes
Other Study ID Numbers: NP25620, 2011-001436-33
Study First Received: September 20, 2011
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014