Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-01 @ 7:34 AM
Study NCT ID:
NCT01428661
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2011-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C478745', 'term': 'tasimelteon'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'curt.wolfgang@vandapharma.com', 'phone': '202-734-3400', 'title': 'Curt Wolfgang, Ph.D.', 'organization': 'Vanda Pharmaceuticals Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'One subject randomized to placebo did not take any study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Tasimelteon', 'description': '20 mg tasimelteon capsules, PO daily for 8 weeks', 'otherNumAtRisk': 254, 'otherNumAffected': 38, 'seriousNumAtRisk': 254, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo capsules, PO daily for 8 weeks', 'otherNumAtRisk': 252, 'otherNumAffected': 53, 'seriousNumAtRisk': 252, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Open Label Tasimelteon', 'description': '20 mg capsules, PO daily for 52 weeks', 'otherNumAtRisk': 339, 'otherNumAffected': 74, 'seriousNumAtRisk': 339, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respitory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 29, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 37, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 47, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 37, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphylococcal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervical Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '339', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tasimelteon', 'description': '20 mg tasimelteon capsules, PO daily for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, PO daily for 8 weeks'}, {'id': 'OG002', 'title': 'Open Label Tasimelteon', 'description': '20 mg capsules, PO daily for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.19', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-7.83', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '-13.6', 'spread': '0.34', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Hamilton Rating Scale for Depression (HAM-D) assesses the range of symptoms that are most frequently observed in subjects with major depressive disorder (MDD) on a scale from 0 to 52. Higher HAM-D scores indicate more severe levels of depressive symptoms, thus, a negative change from baseline indicates a reduction (or improvement) in depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) Population included any subject randomized into the study that receives a dose of study medication and that has completed at least one post-baseline efficacy measurement while on study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tasimelteon', 'description': '20 mg tasimelteon capsules, PO daily for 8 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo capsules, PO daily for 8 weeks'}, {'id': 'FG002', 'title': 'Open Label Tasimelteon', 'description': '20 mg capsules, PO daily for 52 weeks'}], 'periods': [{'title': 'Double-Masked Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}, {'groupId': 'FG001', 'numSubjects': '253'}, {'comment': 'Does not apply.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '204'}, {'comment': 'Does not apply.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': '*Various', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open Label Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Does not apply.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Does not apply.', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '339'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Does not apply.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Does not apply.', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '320'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': '**Various', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '185'}]}]}], 'preAssignmentDetails': '\\*Tasi: subject left country (1); Placebo: sponsor request (1), subject moved (1), IMP schedule (1), subject incarcerated (1), withdrawn after receipt of medical records (1), visit schedule (1)\n\n\\*\\*Tasi: surgery (1), visit schedule (3), +UDS (2), IMP schdule (2), prohibited meds (1), withdrew consent (1), sponsor terminated trial (175)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}, {'value': '846', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tasimelteon', 'description': '20 mg tasimelteon capsules, PO daily for 8 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo capsules, PO daily for 8 weeks'}, {'id': 'BG002', 'title': 'Open Label Tasimelteon', 'description': '20 mg capsules, PO daily for 52 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.7', 'spread': '12.61', 'groupId': 'BG000'}, {'value': '42.0', 'spread': '12.46', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The 2 phases of the trial are being separated out so the additive total is correct for each phase.', 'groupId': 'BG002'}, {'value': '42.9', 'spread': '12.54', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The 2 phases of the trial are being separated out so the additive total is correct for each phase.', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The 2 phases of the trial are being separated out so the additive total is correct for each phase.', 'groupId': 'BG001'}, {'value': '44.1', 'spread': '12.19', 'groupId': 'BG002'}, {'value': '44.1', 'spread': '12.19', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 507}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'dispFirstSubmitDate': '2013-06-12', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-01', 'studyFirstSubmitDate': '2011-08-31', 'dispFirstSubmitQcDate': '2013-06-12', 'resultsFirstSubmitDate': '2015-01-06', 'studyFirstSubmitQcDate': '2011-09-02', 'dispFirstPostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-01', 'studyFirstPostDateStruct': {'date': '2011-09-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)', 'timeFrame': '8 weeks', 'description': 'Hamilton Rating Scale for Depression (HAM-D) assesses the range of symptoms that are most frequently observed in subjects with major depressive disorder (MDD) on a scale from 0 to 52. Higher HAM-D scores indicate more severe levels of depressive symptoms, thus, a negative change from baseline indicates a reduction (or improvement) in depressive symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tasimelteon', 'Major Depressive Disorder', 'MDD', 'depression'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked treatment of tasimelteon or placebo in male and female subjects with Major Depressive Disorder.', 'detailedDescription': "This is a randomized, parallel, double-masked, placebo-controlled, multicenter outpatient study comparing tasimelteon with placebo in the treatment of subjects with Major Depressive Disorder (MDD).\n\nThe study has three phases: the pre-randomization phase, the randomization phase, and an open-label extension phase. The pre-randomization phase comprises a screening visit where subject's initial eligibility will be evaluated. The randomization phase is comprised of an 8-week double-masked segment. Subjects meeting all entry criteria for the study will enter the randomization phase. During this phase, subjects will be asked to take either 20 mg tasimelteon or placebo for 8 weeks in a double-masked fashion. At the end of the 8-week double-masked phase, those subjects who completed the 8-week treatment phase will be offered to enroll into a 52-week open-label extension where each subject will receive daily doses of 20 mg tasimelteon."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with diagnosis of MDD, single or recurrent episode, according to DSM-IV TR criteria;\n* Current episode ≥4 weeks and ≤1 year;\n* CGI-Severity score ≥4 at screening and baseline.\n\nExclusion Criteria:\n\n* Lifetime history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive-compulsive disorder;\n* Any other current Axis I (except general anxiety disorder as long as it is not considered the primary disorder) or Axis II disorder;\n* A positive test for drugs of abuse at the screening visit and/or history of drug or alcohol abuse/dependence as defined in DSM-IV TR, Diagnostic Criteria for Drug and Alcohol Abuse and Dependence, within the past 12 months;\n* Formal psychotherapy within 3 months of the screening visit. General supportive psychotherapy is acceptable;\n* Participation in a previous tasimelteon trial. Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01428661', 'acronym': 'MAGELLAN', 'briefTitle': 'Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'MAGELLAN: A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Study to Investigate the Safety and Efficacy of 20 Mg Tasimelteon Versus Placebo in Adult Subjects With Major Depressive Disorder Followed by a 52-Week Open-Label Extension', 'orgStudyIdInfo': {'id': 'VP-VEC-162-2301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tasimelteon', 'interventionNames': ['Drug: tasimelteon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'tasimelteon', 'type': 'DRUG', 'description': '20 mg once daily', 'armGroupLabels': ['tasimelteon']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'once daily', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92617', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Vanda Investigational Site', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Vanda 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