Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT01188694
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2010-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D008751', 'term': 'Methylene Blue'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zoellner@u.washington.edu', 'phone': '206 685-3617', 'title': 'Lori Zoellner', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Psychotherapy Plus Methylene Blue, USP', 'description': 'Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.', 'otherNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Psychotherapy Plus Placebo', 'description': 'Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.', 'otherNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Delayed Psychotherapy', 'description': 'Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).', 'otherNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea or Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anxiety or Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Eye Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PTSD Symptom Severity-Interview (PSS-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Psychotherapy Plus Methylene Blue, USP', 'description': 'Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.'}, {'id': 'OG001', 'title': 'Psychotherapy Plus Placebo', 'description': 'Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.'}, {'id': 'OG002', 'title': 'Delayed Psychotherapy', 'description': 'Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).'}], 'classes': [{'title': 'Pre-Treatment', 'categories': [{'measurements': [{'value': '32.07', 'spread': '6.17', 'groupId': 'OG000'}, {'value': '31.38', 'spread': '6.88', 'groupId': 'OG001'}, {'value': '32.73', 'spread': '7.24', 'groupId': 'OG002'}]}]}, {'title': 'Post-Treatment', 'categories': [{'measurements': [{'value': '17.10', 'spread': '10.57', 'groupId': 'OG000'}, {'value': '14.67', 'spread': '9.27', 'groupId': 'OG001'}, {'value': '29.60', 'spread': '8.40', 'groupId': 'OG002'}]}]}, {'title': '1 Month Follow-up', 'categories': [{'measurements': [{'value': '10.33', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '13.33', 'spread': '9.15', 'groupId': 'OG001'}, {'value': '28.33', 'spread': '7.43', 'groupId': 'OG002'}]}]}, {'title': '3 Month Follow-up', 'categories': [{'measurements': [{'value': '7.63', 'spread': '5.53', 'groupId': 'OG000'}, {'value': '10.93', 'spread': '9.95', 'groupId': 'OG001'}, {'value': '7.25', 'spread': '9.82', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)', 'description': 'PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Psychotherapy Plus Methylene Blue, USP', 'description': 'Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.'}, {'id': 'FG001', 'title': 'Psychotherapy Plus Placebo', 'description': 'Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.'}, {'id': 'FG002', 'title': 'Delayed Psychotherapy', 'description': 'Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Psychotherapy Plus Methylene Blue, USP', 'description': 'Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.'}, {'id': 'BG001', 'title': 'Psychotherapy Plus Placebo', 'description': 'Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.'}, {'id': 'BG002', 'title': 'Delayed Psychotherapy', 'description': 'Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}], '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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2010-07-20', 'resultsFirstSubmitDate': '2017-01-06', 'studyFirstSubmitQcDate': '2010-08-24', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-16', 'studyFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Symptom Severity-Interview (PSS-I)', 'timeFrame': 'Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)', 'description': 'PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Posttraumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '28686823', 'type': 'DERIVED', 'citation': 'Zoellner LA, Telch M, Foa EB, Farach FJ, McLean CP, Gallop R, Bluett EJ, Cobb A, Gonzalez-Lima F. Enhancing Extinction Learning in Posttraumatic Stress Disorder With Brief Daily Imaginal Exposure and Methylene Blue: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Jul;78(7):e782-e789. doi: 10.4088/JCP.16m10936.'}]}, 'descriptionModule': {'briefSummary': 'Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a traumatic event and intense, persistent feelings of anxiety. There are several effective therapies for PTSD, but they are often time consuming. The investigators want to see if the investigators can shorten treatment time while keeping therapy effective by adding a medication called methylene blue, USP, taken orally as a pill, to the therapy. The specific aims are: 1) To see whether medication plus psychotherapy improves PTSD symptoms more than placebo plus psychotherapy or a waitlist; 2) To examine the long-term outcome of those receiving medication plus psychotherapy 1 and 3 months after treatment has ended; 3) To examine whether medication plus psychotherapy helps with depression, trauma-related cognitions, and functioning.', 'detailedDescription': 'The psychotherapy the investigators are offering in this study is a type of cognitive behavioral therapy called imaginal exposure. In imaginal exposure, the investigators encourage the client to approach the memory of the trauma by recounting the trauma story to the therapist and discussing his or her reactions to the memory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of 12 weeks since the traumatic event.\n2. Between the age of 18 and 65.\n\nExclusion Criteria:\n\n1. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV.\n2. Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).\n3. Current diagnosis of alcohol or substance dependence within the 3 previous months.\n4. Unwilling or unable to discontinue current trauma-focused psychotherapy or psychotropic medication (at least 1 month medication free).\n5. Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).\n6. Unstable cardiovascular, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or hematological disorder or current seizure disorder.\n7. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception for the duration of active treatment.\n8. A history of hypersensitivity or allergy to MB.\n9. Any condition possibly affecting drug absorption (e.g., gastrectomy).\n10. Glucose-6-phosphate dehydrogenase deficiency.\n11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that, in the judgment of the Medical Directors, would make the participant inappropriate for entry.'}, 'identificationModule': {'nctId': 'NCT01188694', 'acronym': 'HELP', 'briefTitle': 'Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)', 'orgStudyIdInfo': {'id': '37340'}, 'secondaryIdInfos': [{'id': 'R34MH087375', 'link': 'https://reporter.nih.gov/quickSearch/R34MH087375', 'type': 'NIH'}, {'id': '107654', 'type': 'OTHER', 'domain': 'FDA IND#'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychotherapy plus Methylene Blue, USP', 'interventionNames': ['Drug: Psychotherapy plus Methylene Blue, USP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Psychotherapy Plus Placebo', 'interventionNames': ['Behavioral: Psychotherapy plus Placebo']}, {'type': 'OTHER', 'label': 'Delayed Psychotherapy', 'interventionNames': ['Behavioral: Delayed Psychotherapy']}], 'interventions': [{'name': 'Psychotherapy plus Methylene Blue, USP', 'type': 'DRUG', 'description': 'This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.', 'armGroupLabels': ['Psychotherapy plus Methylene Blue, USP']}, {'name': 'Psychotherapy plus Placebo', 'type': 'BEHAVIORAL', 'description': 'This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.', 'armGroupLabels': ['Psychotherapy Plus Placebo']}, {'name': 'Delayed Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).', 'armGroupLabels': ['Delayed Psychotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Lori A Zoellner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Texas', 'class': 'OTHER'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Psychology', 'investigatorFullName': 'Lori Zoellner', 'investigatorAffiliation': 'University of Washington'}}}}