Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-27 @ 11:33 AM
Study NCT ID:
NCT01130103
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2010-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack
Sponsor:
Organization:
Raw JSON
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'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'blurry vision', 'stats': [{'groupId': 'EG000', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'impaired coordination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 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'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinician Administered PTSD Scale (CAPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paroxetine', 'description': 'Paroxetine and Prolonged Exposure Therapy'}, {'id': 'OG001', 'title': 'Placebo Pill', 'description': 'Placebo pill plus Prolonged Exposure Therapy'}], 'classes': [{'title': 'week 0', 'categories': [{'measurements': [{'value': '72.6', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '65.4', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'week 5', 'categories': [{'measurements': [{'value': '40.7', 'spread': '28.4', 'groupId': 'OG000'}, {'value': '49.0', 'spread': '23.9', 'groupId': 'OG001'}]}]}, {'title': 'week 10', 'categories': [{'measurements': [{'value': '21.5', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '35.6', 'spread': '31.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'incident rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '.30', 'ciUpperLimit': '.85', 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weeks 0, 5, 10', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'observed data at each time point'}, {'type': 'SECONDARY', 'title': 'Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paroxetine', 'description': 'Paroxetine and Prolonged Exposure Therapy'}, {'id': 'OG001', 'title': 'Placebo Pill', 'description': 'Placebo pill plus Prolonged Exposure Therapy'}], 'classes': [{'title': 'week 0', 'categories': [{'measurements': [{'value': '47.1', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '45.4', 'spread': '18.5', 'groupId': 'OG001'}]}]}, {'title': 'week 5', 'categories': [{'measurements': [{'value': '55.5', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '59.4', 'spread': '17.6', 'groupId': 'OG001'}]}]}, {'title': 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[{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'week 10', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.6', 'ciLowerLimit': '1.23', 'ciUpperLimit': '129', 'groupDescription': 'treatment group effect: remission rate at weeks 5 and 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.8', 'ciLowerLimit': '2.44', 'ciUpperLimit': '176', 'groupDescription': 'rate of change over time in remission rate from week 5 to 10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 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'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment dates: December, 2004 to February, 2009. Location: Anxiety Disorders research clinic.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Paroxetine', 'description': 'Paroxetine and Prolonged Exposure Therapy'}, {'id': 'BG001', 'title': 'Placebo Pill', 'description': 'Placebo pill plus Prolonged Exposure 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': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-30', 'studyFirstSubmitDate': '2010-05-24', 'resultsFirstSubmitDate': '2012-07-09', 'studyFirstSubmitQcDate': '2010-05-24', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-09', 'studyFirstPostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician Administered PTSD Scale (CAPS)', 'timeFrame': 'Weeks 0,5,10', 'description': 'PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD'}, {'measure': 'Number of Participants Who Met Remission Criterion', 'timeFrame': 'Weeks 5,10', 'description': 'remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1'}], 'secondaryOutcomes': [{'measure': 'Treatment Response at Weeks 5 and 10', 'timeFrame': 'weeks 5,10', 'description': 'responder status: CGI-change score of 1 or 2\n\n1=very much improved, 2= much improved'}, {'measure': 'Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms', 'timeFrame': 'weeks 0,5,10', 'description': 'total score at weeks 0, 5, 10'}, {'measure': 'Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10', 'timeFrame': 'weeks 0,5,10', 'description': 'Measures life enjoyment and satisfaction across 16 domains 16 = very poor quality of life to 80 =very good quality of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTSD', 'anxiety disorders', 'trauma'], 'conditions': ['Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '21908494', 'type': 'DERIVED', 'citation': 'Schneier FR, Neria Y, Pavlicova M, Hembree E, Suh EJ, Amsel L, Marshall RD. Combined prolonged exposure therapy and paroxetine for PTSD related to the World Trade Center attack: a randomized controlled trial. Am J Psychiatry. 2012 Jan;169(1):80-8. doi: 10.1176/appi.ajp.2011.11020321. Epub 2011 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.', 'detailedDescription': 'Selective serotonin reuptake inhibitor (SSRI) medication is often recommended in combination with cognitive behavioral therapies for PTSD, but combined initial treatment of PTSD has not been studied under controlled conditions. Also, there are few studies of either treatment in survivors of terrorism. This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the SSRI paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Posttraumatic Stress Disorder, chronic, related to World Trade Center Attacks\n* Age 18-70\n* CAPS score greater than 45\n* Willingness to consent\n* For women, negative pregnancy test and using adequate birth control\n\nExclusion Criteria:\n\n* Prominent suicidal ideation\n* Current psychotic disorder\n* Unstable medical illness\n* Women who are pregnant or nursing mothers\n* Alcohol or substance use disorder in the past 3 months\n* History of seizure disorder\n* conditions that contraindicate use of paroxetine\n* inability to tolerate a drug free period prior to beginning the study of 4 weeks for MAOIs or fluoxetine and 2 weeks for other psychotropic drugs, except zolpidem for insomnia.'}, 'identificationModule': {'nctId': 'NCT01130103', 'briefTitle': 'Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack', 'organization': {'class': 'OTHER', 'fullName': 'Research Foundation for Mental Hygiene, Inc.'}, 'officialTitle': 'Combination Treatment for PTSD After the WTC Attack', 'orgStudyIdInfo': {'id': 'R01MH068173', 'link': 'https://reporter.nih.gov/quickSearch/R01MH068173', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH068173', 'link': 'https://reporter.nih.gov/quickSearch/R01MH068173', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paroxetine', 'description': 'Paroxetine and Prolonged Exposure Therapy', 'interventionNames': ['Drug: Paroxetine', 'Behavioral: Prolonged Exposure Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo pill', 'description': 'Placebo pill plus Prolonged Exposure Therapy', 'interventionNames': ['Behavioral: Prolonged Exposure Therapy']}], 'interventions': [{'name': 'Paroxetine', 'type': 'DRUG', 'otherNames': ['Paxil controlled release (CR)'], 'description': 'Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks', 'armGroupLabels': ['Paroxetine']}, {'name': 'Prolonged Exposure Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Behavioral Therapy'], 'description': 'Weekly for 10 weeks', 'armGroupLabels': ['Paroxetine', 'Placebo pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Franklin Schneier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York State Psychiatric Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Foundation for Mental Hygiene, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Psychiatrist', 'investigatorFullName': 'Franklin Schneier', 'investigatorAffiliation': 'Research Foundation for Mental Hygiene, Inc.'}}}}