Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-03 @ 6:59 AM
Study NCT ID:
NCT00566735
Status:
COMPLETED
Last Update Posted:
2012-12-03
First Post:
2007-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005702', 'term': 'Galantamine'}], 'ancestors': [{'id': 'D047151', 'term': 'Amaryllidaceae Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmatthews@partners.org', 'phone': '617-724-0847', 'title': 'Dr. John Matthews', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The limitations of this study include a small sample size, absence of an optimal galantamine dose determination, and the inclusion of a heterogenous population including MDD, bipolar disorder, and schizoaffective order.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.', 'otherNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Galantamine', 'description': 'Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.', 'otherNumAtRisk': 18, 'otherNumAffected': 13, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.'}, {'id': 'OG001', 'title': 'Galantamine', 'description': 'Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were followed for the duration of hospital stay, an average of 3 weeks', 'description': 'This measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting.', 'unitOfMeasure': 'Number of reported side effects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cognitive Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.'}, {'id': 'OG001', 'title': 'Galantamine', 'description': 'Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.'}], 'classes': [{'title': 'Pre-ECT', 'categories': [{'measurements': [{'value': '80.33', 'spread': '17.87', 'groupId': 'OG000'}, {'value': '88.75', 'spread': '15.64', 'groupId': 'OG001'}]}]}, {'title': 'Post-ECT', 'categories': [{'measurements': [{'value': '68.50', 'spread': '22.65', 'groupId': 'OG000'}, {'value': '88.17', 'spread': '19.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Independent t-test to assess differences between the placebo and galantamine groups in regard to pre- and post-ECT scores on the Delayed Memory Index (DMI).', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom = 28', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Participants were questioned at baseline and after their last electroconvulsive therapy treatment', 'description': "This measure refers to participants' scores on the Delayed Memory Index (DMI) compared from baseline (before first ECT) to discharge (after last ECT). The score can range from 40 to 137. The higher the score, the better, in terms of cognitive functioning.", 'unitOfMeasure': 'Score on the DMI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.'}, {'id': 'OG001', 'title': 'Galantamine', 'description': 'Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.53', 'spread': '4.33', 'groupId': 'OG000'}, {'value': '27.33', 'spread': '4.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants were questioned at baseline', 'description': 'This measure refers to the Hamilton Rating Scale for Depression-17 scores (HAM-D-17) which can range from 0 to 50, with \\<7 referring to mild-to-no depression, and \\>23 referring to severe depression.', 'unitOfMeasure': 'Score on the HAM-D-17', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.'}, {'id': 'FG001', 'title': 'Galantamine', 'description': 'Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Withdrew Before Baseline Measures', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '2 participants withdrew before baselines. Therefore, 18 participants will be included in baselines.', 'groupId': 'FG000', 'numSubjects': '18'}, {'comment': '7 participants withdrew before baselines. Therefore, 12 participants will be included in baselines.', 'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Refused neuropsychological testing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Switched into a manic episode', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.'}, {'id': 'BG001', 'title': 'Galantamine', 'description': 'Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.'}, {'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': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Wechsler Abbreviated Scale of Intelligence (WASI)', 'classes': [{'categories': [{'measurements': [{'value': '102.16', 'spread': '18.21', 'groupId': 'BG000'}, {'value': '104.57', 'spread': '12.35', 'groupId': 'BG001'}, {'value': '103.12', 'spread': '15.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The WASI is a standardized measurement of intelligence quotient (IQ). Scores range from 1 to 160, with 100 signifying average intelligence, scores above 140 signifying superior intelligence, and scores below 40 signifying severe intellectual impairment.', 'unitOfMeasure': 'WASI Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hamilton Depression Rating Scale 17 (HAM-D-17)', 'classes': [{'categories': [{'measurements': [{'value': '27.33', 'spread': '4.33', 'groupId': 'BG000'}, {'value': '24.53', 'spread': '4.33', 'groupId': 'BG001'}, {'value': '26.21', 'spread': '4.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This scale is a rater-administered assessment of depression severity and improvement. Scores range from 0 (not depressed) to 52 (severely depressed).', 'unitOfMeasure': 'HAM-D-17 Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Subjective Mood', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '1.54', 'groupId': 'BG000'}, {'value': '7.88', 'spread': '1.93', 'groupId': 'BG001'}, {'value': '7.95', 'spread': '1.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Subjective Mood Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical-Global Impressions - Severity (CGI-S)', 'classes': [{'categories': [{'measurements': [{'value': '4.75', 'spread': '0.62', 'groupId': 'BG000'}, {'value': '4.41', 'spread': '0.87', 'groupId': 'BG001'}, {'value': '4.61', 'spread': '.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This scale is a rater-administered assessment of severity of symptoms. 1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients', 'unitOfMeasure': 'CGI-S Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Modified Mini Mental Status Exam (3MSE)', 'classes': [{'categories': [{'measurements': [{'value': '91.72', 'spread': '8.05', 'groupId': 'BG000'}, {'value': '90.41', 'spread': '5.48', 'groupId': 'BG001'}, {'value': '91.20', 'spread': '7.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The 3MSE is a rater-administered test that assesses a broad variety of cognitive functioning. Scores range from 0 to 30. Scores greater than 25 indicate a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment.', 'unitOfMeasure': '3MSE Score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-02', 'studyFirstSubmitDate': '2007-12-03', 'resultsFirstSubmitDate': '2012-06-05', 'studyFirstSubmitQcDate': '2007-12-03', 'lastUpdatePostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-02', 'studyFirstPostDateStruct': {'date': '2007-12-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Side Effects', 'timeFrame': 'Participants were followed for the duration of hospital stay, an average of 3 weeks', 'description': 'This measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting.'}], 'secondaryOutcomes': [{'measure': 'Cognitive Functioning', 'timeFrame': 'Participants were questioned at baseline and after their last electroconvulsive therapy treatment', 'description': "This measure refers to participants' scores on the Delayed Memory Index (DMI) compared from baseline (before first ECT) to discharge (after last ECT). The score can range from 40 to 137. The higher the score, the better, in terms of cognitive functioning."}, {'measure': 'Baseline Depressive Symptoms', 'timeFrame': 'Participants were questioned at baseline', 'description': 'This measure refers to the Hamilton Rating Scale for Depression-17 scores (HAM-D-17) which can range from 0 to 50, with \\<7 referring to mild-to-no depression, and \\>23 referring to severe depression.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Major Depression', 'Bipolar Depression', 'Schizoaffective Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat problems with thinking and memory caused by electroconvulsive therapy (ECT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Criteria to enter the study include males and females between the ages of 18-90 (females must be post menopausal) and a DSM-IV diagnosis of Major Depressive Disorder, Major Depressive Disorder with psychotic features, Bipolar Disorder, depressed type, or Schizoaffective Disorder, depressed type (19).\n\nExclusion Criteria:\n\n* DSM-IV diagnoses of dementia and its subtypes\n* Substance use disorder (active use within the last 6 months)\n* Organic mental disorders; seizure disorder\n* Unstable physical disorder or physical disorder judged to significantly affect the central nervous system function\n* A heart rate of \\<60\n* A systolic blood pressure \\< 90\n* Heart block\n* Pre-existing sick-sinus\n* Chronic treatment with beta blockers\n* Any cardiac arrythmia\n* Hypotension\n* Coronary artery disease\n* Liver and renal function impairment\n* Urge incontinence, colitis Crohn's disease, GI motility disorders, asthma and COPD\n* Treatment with anti-cholinergic and cholinomimetic medications; and\n* Female patients who are pregnant.\n* Additionally, women subjects must be postmenopausal, surgically sterile, or using prescription oral contraceptives (e.g. estrogen-progestin combinations) , contraceptive implants (e.g. NorplantTM, DepoProveraTM ), or transdermally delivered contraceptives (Ortho EvraTM) before entry and throughout the study; and have a negative serum b-HCG pregnancy test at screening.\n\nNote: Abstinence and the use of double barrier contraceptive methods are not acceptable in this study."}, 'identificationModule': {'nctId': 'NCT00566735', 'acronym': 'Galantamine', 'briefTitle': 'The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning', 'orgStudyIdInfo': {'id': '2004-P-001051'}, 'secondaryIdInfos': [{'id': 'GAL-EMR-4005', 'type': 'OTHER', 'domain': 'Janssen Pharmaceuticals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2, Galantamine', 'interventionNames': ['Drug: Razadyne']}], 'interventions': [{'name': 'Razadyne', 'type': 'DRUG', 'otherNames': ['Galantamine'], 'description': 'The starting dose of study medication is 4 mg twice a day', 'armGroupLabels': ['2, Galantamine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '4 mg, 2 times a day', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'John D Matthews, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ortho-McNeil Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'John D. Matthews', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}