Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-01-26 @ 1:12 AM
Study NCT ID:
NCT00531518
Status:
COMPLETED
Last Update Posted:
2016-08-15
First Post:
2007-09-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Detection and Intervention for the Prevention of Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}, {'id': 'D005473', 'term': 'Fluoxetine'}, {'id': 'D016642', 'term': 'Bupropion'}, {'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D000077213', 'term': 'Lamotrigine'}, {'id': 'D011615', 'term': 'Psychotherapy, Group'}, {'id': 'D016832', 'term': 'Employment, Supported'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D014227', 'term': 'Triazines'}, {'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004651', 'term': 'Employment'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D012050', 'term': 'Rehabilitation, Vocational'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcfarw@mmc.org', 'phone': '207-662-4348', 'title': 'William R McFarlane, M.D.', 'organization': 'Maine Medical Center Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Over 24 months', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.', 'otherNumAtRisk': 87, 'otherNumAffected': 19, 'seriousNumAtRisk': 87, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Family-aided Assertive Community Treatment', 'description': "This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .\n\naripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations\n\nPsychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work\n\nSupported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.", 'otherNumAtRisk': 205, 'otherNumAffected': 51, 'seriousNumAtRisk': 205, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Negative events', 'notes': '"Negative events" is the measure that includes hospitalizations, incarcerations, assaults, suicides and suicide attempts. It is the sum of such events within each experimental treatment condition.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 51, 'numAffected': 51}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Psychotic Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.'}, {'id': 'OG001', 'title': 'Family-aided Assertive Community Treatment', 'description': "This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .\n\naripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations\n\nPsychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work\n\nSupported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0034', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'The final analysis included adjstment for site and baseline sum psychotic symptom score.', 'groupDescription': 'The analysis used regression discontinuity methods, in which the baseline sum scores were adjusted and centered to an equalize control and experimental conditions.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'two years', 'description': 'Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.'}, {'id': 'FG001', 'title': 'Family-aided Assertive Community Treatment', 'description': "This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .\n\naripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations\n\nPsychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work\n\nSupported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '205'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '71'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.'}, {'id': 'BG001', 'title': 'Experimental Intervention', 'description': "This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .\n\naripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations\n\nPsychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work\n\nSupported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.23', 'spread': '3.18', 'groupId': 'BG000'}, {'value': '16.40', 'spread': '3.30', 'groupId': 'BG001'}, {'value': '16.35', 'spread': '3.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Psychotic symptoms', 'classes': [{'categories': [{'measurements': [{'value': '4.15', 'spread': '1.76', 'groupId': 'BG000'}, {'value': '11.99', 'spread': '3.42', 'groupId': 'BG001'}, {'value': '9.65', 'spread': '4.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All eligible participants (n=292) were entered into the outcome analysis. This was an intent-to-treat study and statistical analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-06', 'studyFirstSubmitDate': '2007-09-18', 'resultsFirstSubmitDate': '2016-01-20', 'studyFirstSubmitQcDate': '2007-09-18', 'lastUpdatePostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-06', 'studyFirstPostDateStruct': {'date': '2007-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychotic Symptoms', 'timeFrame': 'two years', 'description': 'Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Bipolar disorder', 'Psychosis', 'Prodromal psychosis', 'Family psychoeducation', 'Supported education', 'Supported employment', 'Ulra-high-risk for psychosis', 'Major depression', 'Bipolar disorder, with psychotic features', 'Major depression, with psychotic features', 'Attenuated, prodromal psychotic symptoms'], 'conditions': ['Schizophrenia', 'Bipolar Disorder', 'Depression', 'Psychotic Disorders']}, 'referencesModule': {'references': [{'pmid': '26766751', 'type': 'RESULT', 'citation': 'Lynch S, McFarlane WR, Joly B, Adelsheim S, Auther A, Cornblatt BA, Migliorati M, Ragland JD, Sale T, Spring E, Calkins R, Carter CS, Jaynes R, Taylor SF, Downing D. Early Detection, Intervention and Prevention of Psychosis Program: Community Outreach and Early Identification at Six U.S. Sites. Psychiatr Serv. 2016 May 1;67(5):510-6. doi: 10.1176/appi.ps.201300236. Epub 2016 Jan 14.'}, {'pmid': '25065017', 'type': 'RESULT', 'citation': 'McFarlane WR, Levin B, Travis L, Lucas FL, Lynch S, Verdi M, Williams D, Adelsheim S, Calkins R, Carter CS, Cornblatt B, Taylor SF, Auther AM, McFarland B, Melton R, Migliorati M, Niendam T, Ragland JD, Sale T, Salvador M, Spring E. Clinical and functional outcomes after 2 years in the early detection and intervention for the prevention of psychosis multisite effectiveness trial. Schizophr Bull. 2015 Jan;41(1):30-43. doi: 10.1093/schbul/sbu108. Epub 2014 Jul 26.'}], 'seeAlsoLinks': [{'url': 'http://www.preventmentalillness.org', 'label': 'Describes the orientation of the program and early signs of psychosis'}]}, 'descriptionModule': {'briefSummary': 'EDIPP is a multisite trial of early identification and intervention to prevent the onset of psychosis in adolescents and young adults, carried out at six sites across the United States. The hypothesis is that very early identification and intervention will be effective in delaying or preventing onset of psychosis and improving social and occupational functioning.', 'detailedDescription': 'The study is structured as a cutoff, regression discontinuity design, in which lower risk-for-psychosis participants will not be treated by protocol but followed up for two years. Those at higher risk will be treated with anti-psychotic, antidepressant and mood stabilizing medications by symptom indications, and systematically provided psychoeducational multifamily group treatment, supported education and employment, and intensive clinical case management, using key elements of Assertive Community Treatment. Both arms of the study will be followed for two years and assessed at 6, 12, and 24 months. Outcome measures include rates of conversion to psychosis, relapse of psychosis, development of psychotic disorder diagnoses, levels of positive, negative and general symptoms, social and vocational functioning, family functioning, and neurocognitive functioning.\n\nThe six sites include Sacramento, California; Salem Oregon; and surrounding counties, Ypsilanti and Washtenaw County, Michigan; Portland, Maine; Albuquerque, New Mexico and Glen Oaks, New York.\n\nIn addition to symptomatic and functional outcomes, impact on incidence of psychotic disorders, including schizophrenia, will be assessed, as will cost-benefit effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects in the age range of 12-25 and living in the experimental catchment area may be enrolled in the EDIPP study based on meeting at least one of the inclusion requirements AND none of the exclusion criteria;\n* Screening process indicates symptoms equivalent to a minimum rating of '1' on at least one positive symptom of psychosis;\n* Screening process indicates a likely family history of first degree relative with psychotic illness plus a deterioration in functioning equivalent to a 30% drop in functioning score over the past year; OR\n* Screening process indicates a likely history of schizotypal personality disorder plus a deterioration in functioning equivalent to a 30% drop in functioning over the past year.\n\nExclusion Criteria:\n\n* Outside the age range of 12 to 25 years;\n* History of intelligence quotient (IQ) below 70 (based on school records, not tested at PIER);\n* More than one month duration of psychosis (guided by the criteria of at least one 6 on the Positive Symptom sub-scale of the Scale of Positive Symptoms (SOPS);\n* History of previous psychotic episode, whether or not treatment was received;\n* Taken antipsychotic medication for more than 30 days at a therapeutic dose for psychotic symptoms;\n* Either the young person being screened for the study or both parents do not speak proficient English;\n* Female is pregnant at baseline (inquired on the screening interview); AND\n* Subject is a prisoner."}, 'identificationModule': {'nctId': 'NCT00531518', 'acronym': 'EDIPP', 'briefTitle': 'Early Detection and Intervention for the Prevention of Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'MaineHealth'}, 'officialTitle': 'Early Detection and Intervention for the Prevention of Psychosis Project', 'orgStudyIdInfo': {'id': '58920'}, 'secondaryIdInfos': [{'id': 'RWJF #58920', 'type': 'OTHER_GRANT', 'domain': 'Robert Wood Johnson Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.'}, {'type': 'EXPERIMENTAL', 'label': 'Family-aided Assertive Community Treatment', 'description': 'This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .', 'interventionNames': ['Drug: aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine', 'Behavioral: Psychoeducational multifamily group treatment', 'Behavioral: Supported employment and education']}], 'interventions': [{'name': 'aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine', 'type': 'DRUG', 'otherNames': ['Abilify', 'Prozac', 'Welbutrin', 'Zoloft', 'Lamictal'], 'description': "Oral, daily, generally at lower than manufacturer's recommendations", 'armGroupLabels': ['Family-aided Assertive Community Treatment']}, {'name': 'Psychoeducational multifamily group treatment', 'type': 'BEHAVIORAL', 'otherNames': ['Family psychoeducation,', 'Family behavioral therapy', 'Multiple family group therapy'], 'description': 'Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work', 'armGroupLabels': ['Family-aided Assertive Community Treatment']}, {'name': 'Supported employment and education', 'type': 'BEHAVIORAL', 'otherNames': ['Supported employment', 'Supported education'], 'description': 'Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals.', 'armGroupLabels': ['Family-aided Assertive Community Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California-Davis, Imaging Research Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Portland Identification and Early Referral Program', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '48108', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Washtenaw County', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '87131-0001', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11004', 'city': 'Glen Oaks', 'state': 'New York', 'country': 'United States', 'facility': 'Zucker Hillside Hosptial', 'geoPoint': {'lat': 40.74705, 'lon': -73.71152}}, {'zip': '97301', 'city': 'Salem', 'state': 'Oregon', 'country': 'United States', 'facility': 'Mid-Valley Behavioral Care Network', 'geoPoint': {'lat': 44.9429, 'lon': -123.0351}}], 'overallOfficials': [{'name': 'William R. McFarlane, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MaineHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Currently, on request, data will be shared with legitimate organizations for specific analyses approved by the PI and the Maine Medical Center Institutional Review Board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MaineHealth', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'William McFarlane', 'investigatorAffiliation': 'MaineHealth'}}}}