Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-27 @ 12:08 PM
Study NCT ID:
NCT01179568
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2010-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Medication With or Without Psychotherapy for Complicated Grief
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015283', 'term': 'Citalopram'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ks2394@columbia.edu', 'phone': '212-851-2176', 'title': 'M. Katherine Shear, MD', 'organization': 'Columbia School of Social Work'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Two limitations of note: 1) FDA lowered the maximum safe dose of study medication (citalopram) after the study started; 2) our recruitment rate was 90% of target, while the assessment drop-out rate was over double what we expected.'}}, 'adverseEventsModule': {'timeFrame': '5 years', 'description': 'We observed no serious adverse medication effects. CGT therapists monitored participant response to emotionally activating procedures; no serious untoward responses were documented.', 'eventGroups': [{'id': 'EG000', 'title': 'Citalopram', 'description': 'Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.', 'otherNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo (Sugar Pill)', 'description': 'Inactive medication. It is combined with grief-focused clinical management.\n\nPlacebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.', 'otherNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'CGT With Citalopram', 'description': 'The targeted psychotherapy for complicated grief combined with SSRI medication.\n\nComplicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.', 'otherNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'CGT With Placebo', 'description': 'The targeted psychotherapy for complicated grief combined with inactive medication.\n\nComplicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.\n\nPlacebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.', 'otherNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'death by suicide', 'notes': 'Review by the study team and Institutional Review Board determined that this death was not related to the research', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Citalopram (CIT)', 'description': 'Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.'}, {'id': 'OG001', 'title': 'Placebo (PLA; Sugar Pill)', 'description': 'Inactive medication. It is combined with grief-focused clinical management.\n\nPlacebo (PLA): 16 weeks of daily inactive medication. It is administered in a double-blind fashion.'}, {'id': 'OG002', 'title': 'Complicated Grief Treatment With Citalopram (CGT With CIT)', 'description': 'The targeted psychotherapy for complicated grief combined with SSRI medication.\n\nComplicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.'}, {'id': 'OG003', 'title': 'Complicated Grief Treatment With Placebo (CGT With PLA)', 'description': 'The targeted psychotherapy for complicated grief combined with inactive medication.\n\nComplicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.\n\nPlacebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.81', 'groupDescription': 'Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants. With 10% of 440 target enrollment lost to follow-up we had a power of 76-83% to detect predicted between-group difference in response (CGT with PLA, 40%; CGT with CIT, 60%; CIT 40%; and PLA 20%)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \\& race/ethnicity', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.17', 'groupDescription': 'Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs PLA with CGT at week 20 (aim 2) based on the intention-to-treat principle including all randomized participants.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \\& race/ethnicity', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '1', 'ciUpperLimit': '1.46', 'groupDescription': 'Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs CIT at week 20 (aim 3) based on the intention-to-treat principle including all randomized participants.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \\& race/ethnicity', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12 and 20', 'description': 'Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief was be used. Response is defined as a score of 1(very much improved) or 2 (much improved) on the scale. The rating was done by an Independent Evaluator.', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'Response rates were compared under the intention-to-treat principle, including all randomized participants in a logistic regression with inverse probability weighting .'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Inventory of Complicated Grief (ICG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Citalopram (CIT)', 'description': 'Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.'}, {'id': 'OG001', 'title': 'Placebo (PLA; Sugar Pill)', 'description': 'Inactive medication. It is combined with grief-focused clinical management.\n\nPlacebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'spread': '11', 'groupId': 'OG000'}, {'value': '16', 'spread': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.67', 'pValueComment': 'Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \\& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.04', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.', 'unitOfMeasure': 'score change from baseline to wk12', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Inventory of Complicated Grief (ICG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Citalopram (CIT)', 'description': 'Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.'}, {'id': 'OG001', 'title': 'Complicated Grief Treatment With Citalopram (CGT With CIT)', 'description': 'The targeted psychotherapy for complicated grief combined with SSRI medication.\n\nComplicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.'}, {'id': 'OG002', 'title': 'Complicated Grief Treatment With Placebo (CGT With PLA)', 'description': 'The targeted psychotherapy for complicated grief combined with inactive medication.\n\nComplicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.\n\nPlacebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '12', 'groupId': 'OG000'}, {'value': '25', 'spread': '14', 'groupId': 'OG001'}, {'value': '26', 'spread': '12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.53', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.26', 'pValueComment': 'Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \\& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.98', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-7.37', 'pValueComment': 'Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \\& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.08', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 20', 'description': 'The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.', 'unitOfMeasure': 'score change from baseline to wk20', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work and Social Adjustment Scale (WSAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Citalopram (CIT)', 'description': 'Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.'}, {'id': 'OG001', 'title': 'Placebo (PLA; Sugar Pill)', 'description': 'Inactive medication. It is combined with grief-focused clinical management.\n\nPlacebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '11', 'groupId': 'OG000'}, {'value': '8', 'spread': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.84', 'pValueComment': 'Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \\& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.57', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.', 'unitOfMeasure': 'score change from baseline to wk12', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work and Social Adjustment Scale (WSAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Citalopram (CIT)', 'description': 'Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.'}, {'id': 'OG001', 'title': 'Complicated Grief Treatment With Citalopram (CGT With CIT)', 'description': 'The targeted psychotherapy for complicated grief combined with SSRI medication.\n\nComplicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.'}, {'id': 'OG002', 'title': 'Complicated Grief Treatment With Placebo (CGT With PLA)', 'description': 'The targeted psychotherapy for complicated grief combined with inactive medication.\n\nComplicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.\n\nPlacebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '12', 'groupId': 'OG000'}, {'value': '14', 'spread': '10', 'groupId': 'OG001'}, {'value': '16', 'spread': '11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.40', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.44', 'groupDescription': 'Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \\& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.46', 'groupDescription': 'Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \\& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 20', 'description': 'The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.', 'unitOfMeasure': 'score change from baseline to wk20', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Citalopram', 'description': 'Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.'}, {'id': 'FG001', 'title': 'Placebo (Sugar Pill)', 'description': 'Inactive medication. It is combined with grief-focused clinical management.\n\nPlacebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.'}, {'id': 'FG002', 'title': 'CGT With Citalopram', 'description': 'The targeted psychotherapy for complicated grief combined with SSRI medication.\n\nComplicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.'}, {'id': 'FG003', 'title': 'CGT With Placebo', 'description': 'The targeted psychotherapy for complicated grief combined with inactive medication.\n\nComplicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.\n\nPlacebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '96'}]}, {'type': 'Completed Week 12 Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '76'}, {'groupId': 'FG003', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'comment': 'Week 20 assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '76'}, {'groupId': 'FG003', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '20'}]}]}], 'recruitmentDetails': 'Bereaved individuals age 18-95 were recruited between March 2010 and September 2014 using professional and public outreach, print, broadcast and internet media. Referrals were made by health care professionals, bereavement counselors and patients or family members.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}, {'value': '395', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Citalopram', 'description': 'Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.'}, {'id': 'BG001', 'title': 'Placebo (Sugar Pill)', 'description': 'Inactive medication. It is combined with grief-focused clinical management.\n\nPlacebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.'}, {'id': 'BG002', 'title': 'CGT With Citalopram', 'description': 'The targeted psychotherapy for complicated grief combined with SSRI medication.\n\nComplicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.\n\nCitalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.'}, {'id': 'BG003', 'title': 'CGT With Placebo', 'description': 'The targeted psychotherapy for complicated grief combined with inactive medication.\n\nComplicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.\n\nPlacebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '53.9', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '52.1', 'spread': '15.3', 'groupId': 'BG002'}, {'value': '53.5', 'spread': '16.0', 'groupId': 'BG003'}, {'value': '53.0', 'spread': '14.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': '308', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '350', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'While', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': '325', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 395}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-28', 'studyFirstSubmitDate': '2010-07-14', 'resultsFirstSubmitDate': '2016-09-06', 'studyFirstSubmitQcDate': '2010-08-10', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-28', 'studyFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale', 'timeFrame': 'Weeks 12 and 20', 'description': 'Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief was be used. Response is defined as a score of 1(very much improved) or 2 (much improved) on the scale. The rating was done by an Independent Evaluator.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Inventory of Complicated Grief (ICG)', 'timeFrame': 'Baseline and week 12', 'description': 'The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.'}, {'measure': 'Change From Baseline in Inventory of Complicated Grief (ICG)', 'timeFrame': 'Baseline and week 20', 'description': 'The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.'}, {'measure': 'Change From Baseline in Work and Social Adjustment Scale (WSAS)', 'timeFrame': 'Baseline and week 12', 'description': 'The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.'}, {'measure': 'Change From Baseline in Work and Social Adjustment Scale (WSAS)', 'timeFrame': 'Baseline and week 20', 'description': 'The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Grief', 'Bereavement', 'Psychotherapy', 'Medication', 'Treatment study'], 'conditions': ['Complicated Grief', 'Bereavement']}, 'referencesModule': {'references': [{'pmid': '17974946', 'type': 'BACKGROUND', 'citation': 'Simon NM, Thompson EH, Pollack MH, Shear MK. Complicated grief: a case series using escitalopram. Am J Psychiatry. 2007 Nov;164(11):1760-1. doi: 10.1176/appi.ajp.2007.07050800. No abstract available.'}, {'pmid': '15928281', 'type': 'BACKGROUND', 'citation': 'Shear K, Frank E, Houck PR, Reynolds CF 3rd. Treatment of complicated grief: a randomized controlled trial. JAMA. 2005 Jun 1;293(21):2601-8. doi: 10.1001/jama.293.21.2601.'}, {'pmid': '4860352', 'type': 'BACKGROUND', 'citation': 'Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967 Aug;20(8):637-48. doi: 10.1016/0021-9681(67)90041-0. No abstract available.'}, {'pmid': '14506122', 'type': 'BACKGROUND', 'citation': 'Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003 Sep 24;290(12):1624-32. doi: 10.1001/jama.290.12.1624.'}, {'pmid': '3684751', 'type': 'BACKGROUND', 'citation': 'Jacobs SC, Nelson JC, Zisook S. Treating depressions of bereavement with antidepressants. A pilot study. Psychiatr Clin North Am. 1987 Sep;10(3):501-10.'}, {'pmid': '25564898', 'type': 'BACKGROUND', 'citation': 'Shear MK. Clinical practice. Complicated grief. N Engl J Med. 2015 Jan 8;372(2):153-60. doi: 10.1056/NEJMcp1315618. No abstract available.'}, {'pmid': '39711702', 'type': 'DERIVED', 'citation': 'Calderon A, Irwin M, Simon NM, Shear MK, Mauro C, Zisook S, Reynolds CF 3rd, Malgaroli M. Depression is Associated with Treatment Response Trajectories in Adults with Prolonged Grief Disorder: A Machine Learning Analysis. medRxiv [Preprint]. 2024 Dec 12:2024.12.11.24318861. doi: 10.1101/2024.12.11.24318861.'}, {'pmid': '34000119', 'type': 'DERIVED', 'citation': 'Na PJ, Adhikari S, Szuhany KL, Chen AZ, Suzuki RR, Malgaroli M, Robinaugh DJ, Bui E, Mauro C, Skritskaya NA, Lebowitz BD, Zisook S, Reynolds CF 3rd, Shear MK, Simon NM. Posttraumatic Distress Symptoms and Their Response to Treatment in Adults With Prolonged Grief Disorder. J Clin Psychiatry. 2021 Apr 20;82(3):20m13576. doi: 10.4088/JCP.20m13576.'}, {'pmid': '29617064', 'type': 'DERIVED', 'citation': 'Zisook S, Shear MK, Reynolds CF, Simon NM, Mauro C, Skritskaya NA, Lebowitz B, Wang Y, Tal I, Glorioso D, Wetherell JL, Iglewicz A, Robinaugh D, Qiu X. Treatment of Complicated Grief in Survivors of Suicide Loss: A HEAL Report. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11592. doi: 10.4088/JCP.17m11592.'}, {'pmid': '27276373', 'type': 'DERIVED', 'citation': 'Shear MK, Reynolds CF 3rd, Simon NM, Zisook S, Wang Y, Mauro C, Duan N, Lebowitz B, Skritskaya N. Optimizing Treatment of Complicated Grief: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jul 1;73(7):685-94. doi: 10.1001/jamapsychiatry.2016.0892.'}], 'seeAlsoLinks': [{'url': 'http://www.healstudy.org', 'label': 'Complicated Grief Research Group at University of Pittsburgh Medical Center'}, {'url': 'http://www.complicatedgrief.org/', 'label': 'Complicated Grief Program at Columbia University, New York'}]}, 'descriptionModule': {'briefSummary': 'The major goal of this 4-site, double blind, placebo-controlled intervention trial is to assess the efficacy of medication (Citalopram) alone or with psychotherapy (Complicated Grief Therapy) to treat the symptoms of complicated grief.', 'detailedDescription': 'Complicated grief (CG) is a debilitating condition that is estimated to affect millions of people in the United States alone. We conducted the first randomized controlled study to address this condition (MH60783) and confirmed efficacy of a targeted psychotherapy, complicated grief treatment (CGT). Participants in our prior study continued stable antidepressant medication while receiving CGT or Interpersonal Psychotherapy (IPT). Individuals taking antidepressants had better outcome in both treatments, though CGT was superior to IPT when administered with (60% responders v. 40%) or without (42% v.19%) antidepressants. Studies of antidepressant medication alone have shown mixed results with SSRIs appearing to be promising. However, there has been no randomized controlled study of SSRIs for CG. Determining the efficacy of SSRI treatment for CG, when administered with and without CGT, is of great public health importance.\n\nWe assembled 4 groups of investigators with strong track records in bereavement research and extensive experience with intervention studies and multicenter projects, to conduct a study of citalopram (CIT) efficacy. We plan to enroll participants with a primary diagnosis of Complicated Grief and randomly assign them (n=480; 50 at Columbia) to receive treatment with CIT, Placebo (PBO), CIT + CGT or PBO + CGT over a period of approximately 16 weeks. We want to determine whether citalopram shows a better response than placebo, when administered either with or without CGT. We will also address the question of whether CIT performs as well when administered alone as it does when administered with CGT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with Complicated Grief and this is the patient's most important (primary) problem\n* Ability to give informed consent\n* Fluent in English\n* Willingness to have sessions audiotaped\n* Willingness to undergo random assignment\n\nExclusion Criteria:\n\n* Diagnosis of one or more of the following disorders: Schizophrenia or other psychotic disorder, current (past 6 months) substance abuse, Bipolar Disorder, current manic episode, Dementia\n* Pregnant or lactating women and women of childbearing potential not using medically accepted forms of contraception\n* Acute, unstable or severe medical illness such as (but not limited to) stroke, epilepsy, or other neurodegenerative disorders, metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis\n* Prior intolerance of citalopram\n* Pending or active disability claim or lawsuit related to the death"}, 'identificationModule': {'nctId': 'NCT01179568', 'acronym': 'HEAL', 'briefTitle': 'A Study of Medication With or Without Psychotherapy for Complicated Grief', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Optimizing Treatment for Complicated Grief (Healing Emotions After Loss:HEAL)', 'orgStudyIdInfo': {'id': '5971'}, 'secondaryIdInfos': [{'id': 'R01MH060783', 'link': 'https://reporter.nih.gov/quickSearch/R01MH060783', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CGT with Citalopram', 'description': 'Targeted psychotherapy for complicated grief will be combined with SSRI medication.', 'interventionNames': ['Drug: Citalopram', 'Behavioral: Complicated Grief Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Citalopram', 'description': 'Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It will be combined with grief-focused clinical management.', 'interventionNames': ['Drug: Citalopram']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Sugar pill)', 'description': 'Inactive medication. It will be combined with grief-focused clinical management.', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CGT with Placebo', 'description': 'The targeted psychotherapy for complicated grief will be combined with inactive medication.', 'interventionNames': ['Behavioral: Complicated Grief Treatment', 'Other: Placebo']}], 'interventions': [{'name': 'Citalopram', 'type': 'DRUG', 'otherNames': ['Celexa'], 'description': '16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.', 'armGroupLabels': ['CGT with Citalopram', 'Citalopram']}, {'name': 'Complicated Grief Treatment', 'type': 'BEHAVIORAL', 'otherNames': ['CGT'], 'description': 'Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.', 'armGroupLabels': ['CGT with Citalopram', 'CGT with Placebo']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Sugar pill'], 'description': '16 weeks of daily inactive medication. It will be administered in a double-blind fashion.', 'armGroupLabels': ['CGT with Placebo', 'Placebo (Sugar pill)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VASDHS / University of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Katherine Shear, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'American Foundation for Suicide Prevention', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}