Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-31 @ 7:59 PM
Study NCT ID:
NCT02631694
Status:
UNKNOWN
Last Update Posted:
2015-12-16
First Post:
2015-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Disruption of Memory Reconsolidating as a Treatment for Panic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016584', 'term': 'Panic Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}, {'id': 'D002245', 'term': 'Carbon Dioxide'}, {'id': 'D058868', 'term': 'Compressed Air'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'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': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000388', 'term': 'Air'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-11', 'studyFirstSubmitDate': '2015-12-09', 'studyFirstSubmitQcDate': '2015-12-11', 'lastUpdatePostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Score on the Anxiety Sensitivity Index (ASI)', 'timeFrame': 'Baseline'}], 'primaryOutcomes': [{'measure': 'Change in the number of participants diagnosed with panic disorder assessed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth addition (DSM-IV) Axis I Disorders', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Change in score on the Panic Disorder Severity Scale (PDSS-SR)', 'timeFrame': 'Baseline, 7 days, 3 months'}], 'secondaryOutcomes': [{'measure': 'Carbon dioxide challenge using a visual analogue scale ranging from 0-100 mm', 'timeFrame': '3 months', 'description': 'Participants are asked to rate on a visual analogue scale ranging from 0-100 mm the degree to which they are willing to inhale carbon dioxide again if this were requested. Secondly, participants will indeed be requested to perform the challenge a second time and rate on the visual analogue scale how anxious it made them feel.'}, {'measure': 'Change in score on the Panic Appraisal Inventory (PAI)', 'timeFrame': 'Baseline, 7 days, 3 months, 6 months, 1 year'}, {'measure': 'Change in score on the Mobility Inventory (MI)', 'timeFrame': 'Baseline, 7 days, 3 months, 6 months, 1 year'}, {'measure': 'Change in score on the Body Sensations Questionnaire (BSQ)', 'timeFrame': 'Baseline, 7 days, 3 months, 6 months, 1 year'}, {'measure': 'Change in score on the Agoraphobic Cognitions Questionnaire (ACQ)', 'timeFrame': 'Baseline, 7 days, 3 months, 6 months, 1 year'}, {'measure': 'Change in the number of participants diagnosed with panic disorder assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders', 'timeFrame': 'Baseline, 6 months, 1 year'}, {'measure': 'Change in score on the Panic Disorder Severity Scale (PDSS-SR)', 'timeFrame': 'Baseline, 6 months, 1 year'}]}, 'conditionsModule': {'conditions': ['Panic Disorder']}, 'descriptionModule': {'briefSummary': 'Animal and human fear conditioning studies have repeatedly shown that administering propranolol before or after retrieval of a previously acquired fear results in an elimination of the fear expression. This approach, known as disruption of fear memory reconsolidation, is a promising new avenue for treating anxiety disorders. The present study aims to test its efficacy in patients with panic disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a primary diagnosis of panic disorder according to DSM-V\n* written approval of an independent physician for participation\n\nExclusion Criteria:\n\n* other relevant treatment for panic disorder at the time of study - e.g., Cognitive Behavioral Therapy (CBT)\n* diagnosis of depression\n* diagnosis of psychosis\n* use of psychotropic medication\n* history of pulmonary diseases\n* metabolic acidosis\n* history of cardiovascular diseases\n* heart problems among first-degree relatives\n* heart rate (HR) \\< 60\n* blood pressure (BP) \\< 90-60 or BP \\> 170-100\n* history of black-outs or fainting\n* diabetes\n* liver or kidney diseases\n* hyperactive production of thyroid hormones\n* epilepsy\n* any medication contra-indicative of the use of propranolol\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02631694', 'briefTitle': 'Disruption of Memory Reconsolidating as a Treatment for Panic Disorder', 'organization': {'class': 'OTHER', 'fullName': 'VU University of Amsterdam'}, 'officialTitle': 'Targeting Fear Memory by Disrupting the Process of Reconsolidating: A New Intervention for Panic Disorder', 'orgStudyIdInfo': {'id': 'MKAEWC1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fear reactivation with propranolol', 'interventionNames': ['Drug: Propranolol', 'Other: Carbon dioxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Fear reactivation with placebo', 'interventionNames': ['Drug: Placebo', 'Other: Carbon dioxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No fear reactivation with propranolol', 'interventionNames': ['Drug: Propranolol', 'Other: Compressed air']}], 'interventions': [{'name': 'Propranolol', 'type': 'DRUG', 'description': 'Intake of propranolol pill (40 milligram)', 'armGroupLabels': ['Fear reactivation with propranolol', 'No fear reactivation with propranolol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intake of placebo pill (40 milligram)', 'armGroupLabels': ['Fear reactivation with placebo']}, {'name': 'Carbon dioxide', 'type': 'OTHER', 'description': 'Inhalation of 35% carbon dioxide', 'armGroupLabels': ['Fear reactivation with placebo', 'Fear reactivation with propranolol']}, {'name': 'Compressed air', 'type': 'OTHER', 'description': 'Inhalation of air', 'armGroupLabels': ['No fear reactivation with propranolol']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Arnold A.P. van Emmerik, PhD', 'role': 'CONTACT', 'email': 'A.A.P.vanEmmerik@uva.nl', 'phone': '0031205258604'}], 'overallOfficials': [{'name': 'Merel Kindt, Prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Amsterdam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VU University of Amsterdam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Experimental and Clinical Psychology', 'investigatorFullName': 'Mrs. M. Kindt', 'investigatorAffiliation': 'VU University of Amsterdam'}}}}