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
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| ClinicalTrials.gov Identifier: NCT01437657 |
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Recruitment Status :
Completed
First Posted : September 21, 2011
Last Update Posted : November 2, 2016
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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 |
|---|---|---|
| Major Depressive Disorder | Drug: Placebo Drug: RO4917523 0.5 mg Drug: RO4917523 1.5 mg | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| 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 : | October 2011 |
| Actual Primary Completion Date : | September 2013 |
| Actual Study Completion Date : | September 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
MedlinePlus related topics:
Antidepressants
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Matching RO4917523 placebo orally daily, 6 weeks
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Drug: Placebo
Matching RO4917523 placebo orally daily, 6 weeks |
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Experimental: RO4917523 0.5 mg
0.5 mg orally daily, 6 weeks
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Drug: RO4917523 0.5 mg
0.5 mg orally daily, 6 weeks |
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Experimental: RO4917523 1.5 mg
1.5 mg orally daily, 6 weeks
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Drug: RO4917523 1.5 mg
1.5 mg orally daily, 6 weeks |
Primary Outcome Measures :
- Change in Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: From baseline to Week 6 ]
Secondary Outcome Measures :
- Change in Clinical Global Impression Score - Severity (CGI-S) [ Time Frame: From baseline to Week 6 ]
- Change in Clinical Global Impression Score - Improvement (CGI-I) [ Time Frame: From baseline to Week 6 ]
- Safety: Incidence of adverse events [ Time Frame: approximately 2 years ]
- Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment [ Time Frame: approximately 2 years ]
- Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment [ Time Frame: approximately 2 years ]
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437657
Locations
Show 76 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01437657 |
| Other Study ID Numbers: |
NP25620 2011-001436-33 ( EudraCT Number ) |
| First Posted: | September 21, 2011 Key Record Dates |
| Last Update Posted: | November 2, 2016 |
| Last Verified: | November 2016 |
Additional relevant MeSH terms:
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Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |