Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00502320
Status:
COMPLETED
Last Update Posted:
2009-10-06
First Post:
2007-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder
Sponsor:
Organization:
Raw JSON
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Norris, MD', 'organization': 'Lehigh Valley Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ramelteon', 'description': '8 mg pill taken by mouth nightly', 'otherNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'inactive sugar pill taken by mouth nightly', 'otherNumAffected': 5, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia Exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nightmares', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Worsening depression leading to hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': '8 mg pill taken by mouth nightly'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'inactive sugar pill taken by mouth nightly'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '11.56', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '11.45', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '9.52', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '8.67', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '7.57', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '8.62', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '8.07', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '9.88', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '7.05', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '9.61', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Monthly for duration of treatment (up to 4 months)', 'description': 'Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Score ranges from 0-21, higher scores represent more significant sleep disturbance.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat analysis; excludes one screen failure.'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': '8 mg pill taken by mouth nightly'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'inactive sugar pill taken by mouth nightly'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '63.06', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '58.63', 'spread': '1.96', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '54.35', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '56.40', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '53.51', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '58.59', 'spread': '2.80', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '49.26', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '58.62', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '46.14', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '61.65', 'spread': '2.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Monthly for duration of treatment (up to 4 months)', 'description': 'Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat analysis; excludes one screen failure.'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': '8 mg pill taken by mouth nightly'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'inactive sugar pill taken by mouth nightly'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.68', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '19.99', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '16.16', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '15.97', 'spread': '2.04', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '14.81', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '19.47', 'spread': '1.96', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '11.69', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '20.65', 'spread': '1.67', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '9.15', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '23.68', 'spread': '1.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Monthly for duration of treatment (up to 4 months)', 'description': 'Clinician-rated measure of mood; evaluates classical 21 Hamilton Depression items, and 8-item subscale measuring atypical depression symptoms which commonly occur during SAD episodes. Score ranges from 0-89, higher scores indicate higher levels of depression.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat analysis; excludes one screen failure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ramelteon', 'description': '8 mg pill taken by mouth nightly'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'inactive sugar pill taken by mouth nightly'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Screening Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'comment': 'Participant signed informed consent but was a screen failure because she was nursing at the time.', 'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No longer met criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Recruitment began in August 2006 and was completed by October 2007. Participants, who at the time were receiving outpatient psychiatric services through Lehigh Valley Hospital, were recruited via referral through the department of psychiatry, and also through print advertisement. Participants received no compensation for participating in the study.', 'preAssignmentDetails': '50 individuals signed the informed consent document, one was a screen failure, so 49 participants started study medication. During the study, both treatment groups were maintained on their usual medications for depression and allowed treatment as usual, including medication adjustments.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ramelteon', 'description': '8 mg pill taken by mouth nightly'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'inactive sugar pill taken by mouth nightly'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.49', 'spread': '11.81', 'groupId': 'BG000'}, {'value': '47.76', 'spread': '10.23', 'groupId': 'BG001'}, {'value': '46.08', 'spread': '11.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-02', 'studyFirstSubmitDate': '2007-07-13', 'resultsFirstSubmitDate': '2009-07-21', 'studyFirstSubmitQcDate': '2007-07-13', 'lastUpdatePostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-08-28', 'studyFirstPostDateStruct': {'date': '2007-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Monthly for duration of treatment (up to 4 months)', 'description': 'Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Score ranges from 0-21, higher scores represent more significant sleep disturbance.'}], 'secondaryOutcomes': [{'measure': 'Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)', 'timeFrame': 'Monthly for duration of treatment (up to 4 months)', 'description': 'Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression.'}, {'measure': 'Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)', 'timeFrame': 'Monthly for duration of treatment (up to 4 months)', 'description': 'Clinician-rated measure of mood; evaluates classical 21 Hamilton Depression items, and 8-item subscale measuring atypical depression symptoms which commonly occur during SAD episodes. Score ranges from 0-89, higher scores indicate higher levels of depression.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Seasonal Affective Disorder', 'Ramelteon', 'Psychiatry', 'Randomized Controlled Trial', 'Hamilton Depression Rating Scale- SAD Version', 'Circadian Rhythm'], 'conditions': ['Seasonal Affective Disorder']}, 'referencesModule': {'references': [{'pmid': '11513820', 'type': 'BACKGROUND', 'citation': 'Avery DH, Eder DN, Bolte MA, Hellekson CJ, Dunner DL, Vitiello MV, Prinz PN. Dawn simulation and bright light in the treatment of SAD: a controlled study. Biol Psychiatry. 2001 Aug 1;50(3):205-16. doi: 10.1016/s0006-3223(01)01200-8.'}, {'pmid': '638392', 'type': 'BACKGROUND', 'citation': 'Biggs JT, Wylie LT, Ziegler VE. Validity of the Zung Self-rating Depression Scale. 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Assessment. 2002 Dec;9(4):401-5. doi: 10.1177/1073191102238471.'}, {'pmid': '14593433', 'type': 'BACKGROUND', 'citation': 'Willeit M, Praschak-Rieder N, Neumeister A, Zill P, Leisch F, Stastny J, Hilger E, Thierry N, Konstantinidis A, Winkler D, Fuchs K, Sieghart W, Aschauer H, Ackenheil M, Bondy B, Kasper S. A polymorphism (5-HTTLPR) in the serotonin transporter promoter gene is associated with DSM-IV depression subtypes in seasonal affective disorder. Mol Psychiatry. 2003 Nov;8(11):942-6. doi: 10.1038/sj.mp.4001392.'}, {'type': 'BACKGROUND', 'citation': 'William JBW, Link MJ, Rosenthal NE, Terman M. (1988). Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorders Version (SIGH-SAD). New York, New York State Psychiatric Institute'}, {'pmid': '14221692', 'type': 'BACKGROUND', 'citation': 'ZUNG WW. A SELF-RATING DEPRESSION SCALE. Arch Gen Psychiatry. 1965 Jan;12:63-70. doi: 10.1001/archpsyc.1965.01720310065008. No abstract available.'}, {'pmid': '4381571', 'type': 'BACKGROUND', 'citation': 'Zung WW. Factors influencing the self-rating depression scale. Arch Gen Psychiatry. 1967 May;16(5):543-7. doi: 10.1001/archpsyc.1967.01730230027003. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC, American Psychiatric Association, 2000.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether treating sleep difficulties in patients with seasonal affective disorder also improves their depressive symptoms.', 'detailedDescription': "Seasonal affective disorder(SAD) is a type of depression in which a patient's depressive symptoms worsen in the winter. These patients' depressive symptoms often lessen in the spring and summer months. Much of the focus of the treatment of SAD (light therapy and melatonin) has involved the brain's suprachiasmatic nucleus(SCN), as it is hypothesized that one potential reason for SAD is a desynchronized SCN. Ramelteon offers a new and more pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon for this patient population may improve sleep, and in addition, do so in a manner that may also reduce their seasonal affective depressive symptoms. Patients eligible for enrollment will be administered either ramelteon or placebo and return to the study office for 4 monthly visits over the winter months, to evaluate the effects of ramelteon versus placebo on sleep and mood."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female age 18-65 yrs.\n* A diagnosis of seasonal affective disorder\n* A Pittsburgh Sleep Quality Index \\>5\n* English speaking\n* Be able to sign informed consent\n\nExclusion Criteria:\n\n* Active substance abuse\n* Current psychotic symptoms\n* Severe personality disorders\n* Primary sleep disorders\n* Severe chronic obstructive pulmonary disease (COPD)\n* Prescription fluvoxamine(Luvox) use'}, 'identificationModule': {'nctId': 'NCT00502320', 'acronym': 'SAM-SAD', 'briefTitle': 'Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Lehigh Valley Hospital'}, 'officialTitle': 'Randomized Placebo-Controlled Trial of Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder', 'orgStudyIdInfo': {'id': '06-006R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ramelteon', 'description': '8 mg', 'interventionNames': ['Drug: Ramelteon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ramelteon', 'type': 'DRUG', 'otherNames': ['Rozerem'], 'description': 'one 8 mg tablet at bed for up to 4 months', 'armGroupLabels': ['Ramelteon']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'one tablet at bedtime for up to 4 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Hospital, Department of Psychiatry', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}], 'overallOfficials': [{'name': 'Edward R. Norris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lehigh Valley Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lehigh Valley Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda Pharmaceuticals North America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Edward R. Norris, MD', 'oldOrganization': 'Lehigh Valley Hospital'}}}}