Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-09 @ 5:00 AM
Study NCT ID:
NCT01437657
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596770', 'term': '2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2016-07-06', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-09-20', 'dispFirstSubmitQcDate': '2016-07-06', 'studyFirstSubmitQcDate': '2011-09-20', 'dispFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Montgomery Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'From baseline to Week 6'}], 'secondaryOutcomes': [{'measure': 'Change in Clinical Global Impression Score - Severity (CGI-S)', 'timeFrame': 'From baseline to Week 6'}, {'measure': 'Change in Clinical Global Impression Score - Improvement (CGI-I)', 'timeFrame': 'From baseline to Week 6'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 2 years'}, {'measure': 'Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment', 'timeFrame': 'approximately 2 years'}, {'measure': 'Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment', 'timeFrame': 'approximately 2 years'}]}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '27304433', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient, 18 to 70 years of age at time of informed consent\n* Major depressive disorder without psychotic features as defined by DSM-IV-TR criteria\n* Inadequate response to ongoing antidepressant treatment, as defined by protocol\n* Body mass index (BMI) 18 to 38 kg/m2 inclusive\n\nExclusion Criteria:\n\n* Currently receiving treatment with a combination of antidepressants (two or more), or an adjunctive potentiating treatment as defined by protocol\n* Previously received RO4917523\n* History of failure, or utilization during the current episode of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)\n* History of use at any time of Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation (DBS)\n* Current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed episodes)\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01437657', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NP25620'}, 'secondaryIdInfos': [{'id': '2011-001436-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching RO4917523 placebo orally daily, 6 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'RO4917523 0.5 mg', 'description': '0.5 mg orally daily, 6 weeks', 'interventionNames': ['Drug: RO4917523 0.5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'RO4917523 1.5 mg', 'description': '1.5 mg orally daily, 6 weeks', 'interventionNames': ['Drug: RO4917523 1.5 mg']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching RO4917523 placebo orally daily, 6 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'RO4917523 0.5 mg', 'type': 'DRUG', 'description': '0.5 mg orally daily, 6 weeks', 'armGroupLabels': ['RO4917523 0.5 mg']}, {'name': 'RO4917523 1.5 mg', 'type': 'DRUG', 'description': '1.5 mg orally daily, 6 weeks', 'armGroupLabels': ['RO4917523 1.5 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72223', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 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