Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT01110902
Status:
COMPLETED
Last Update Posted:
2020-12-24
First Post:
2010-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C084711', 'term': 'agomelatine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 589}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'dispFirstSubmitDate': '2012-07-24', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2010-04-23', 'dispFirstSubmitQcDate': '2012-07-24', 'studyFirstSubmitQcDate': '2010-04-26', 'dispFirstPostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale', 'timeFrame': 'Baseline and 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8', 'timeFrame': '8 weeks'}, {'measure': 'Proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the Baseline clinician-rated HAM-D total score at Week 8 endpoint', 'timeFrame': '8 weeks'}, {'measure': 'Proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale', 'timeFrame': '8 weeks'}, {'measure': 'Proportion of patients who achieve remission', 'timeFrame': '8 weeks'}, {'measure': 'Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale.', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'keywords': ['Agomelatine', 'Major Depressive Disorder', 'MDD', 'depression'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6523', 'label': 'Results for CAGO178C2302 from the Novartis Clinical Trials website'}, {'url': 'http://novartisclinicaltrials.com', 'label': 'Click here for more information about this study:'}]}, 'descriptionModule': {'briefSummary': 'The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.\n* Current episode ≥4 weeks.\n* CGI-Severity score ≥4 at Screening and Baseline.\n\nExclusion Criteria:\n\n* History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.\n* Any other current Axis I disorder other than MDD which is the focus of treatment.\n* Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.\n* Concomitant psychotropic medication, including herbal preparations and melatonin.\n* Psychotherapy of any type.\n* Prior exposure to agomelatine.\n* Female patients of childbearing potential who are not using effective contraception.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01110902', 'briefTitle': 'Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)', 'orgStudyIdInfo': {'id': 'CAGO178C2302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AGO178C 0.5 mg /day', 'interventionNames': ['Drug: Agomelatine (AGO178C)']}, {'type': 'EXPERIMENTAL', 'label': 'AGO178C 1 mg / day', 'interventionNames': ['Drug: Agomelatine (AGO178C)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Agomelatine (AGO178C)', 'type': 'DRUG', 'armGroupLabels': ['AGO178C 0.5 mg /day', 'AGO178C 1 mg / day']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham, Department of Psychiatry', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'ATP Clinical Research', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92243', 'city': 'El Centro', 'state': 'California', 'country': 'United States', 'facility': 'Valley Clinical Research', 'geoPoint': {'lat': 32.792, 'lon': -115.56305}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network', 'geoPoint': {'lat': 33.77391, 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