Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00603018
Status:
COMPLETED
Last Update Posted:
2016-09-23
First Post:
2007-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PET Imaging Study of Recovered Anorexics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D000855', 'term': 'Anorexia'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wkaye@ucsd.edu', 'phone': '858- 534-8019', 'title': 'Walter Kaye, MD/Director, Eating Disorders Program Professor, UCSD Department of Psychiatry', 'organization': 'UCSD'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1/Recovered Anorexia', 'description': 'Recovered anorexia\n\nFluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1/Recovered Anorexia Before 8 Weeks of Treatment', 'description': '1/Recovered anorexia before 8 weeks of treatment\n\nBaseline'}, {'id': 'OG001', 'title': '1/Recovered Anorexia After 8 Weeks of Treatment', 'description': '1/Recovered anorexia after 8 weeks of treatment\n\nFluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.'}], 'classes': [{'title': 'insula', 'categories': [{'measurements': [{'value': '5.97', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '5.89', 'spread': '2.17', 'groupId': 'OG001'}]}]}, {'title': 'medial temporal lobe', 'categories': [{'measurements': [{'value': '6.66', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '6.91', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': 'amygdala', 'categories': [{'measurements': [{'value': '5.91', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '6.29', 'spread': '3.17', 'groupId': 'OG001'}]}]}, {'title': 'hippocampus', 'categories': [{'measurements': [{'value': '9.08', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '9.92', 'spread': '4.75', 'groupId': 'OG001'}]}]}, {'title': 'midbrain', 'categories': [{'measurements': [{'value': '0.37', 'spread': '.16', 'groupId': 'OG000'}, {'value': '.58', 'spread': '.36', 'groupId': 'OG001'}]}]}, {'title': 'anterior cingulate cortex', 'categories': [{'measurements': [{'value': '3.83', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '4.12', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'parahippocampal gyrus', 'categories': [{'measurements': [{'value': '6.08', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '6.05', 'spread': '1.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'We used PET and \\[11C\\]WAY to assess 5-HT1A binding potential (BP) = \\[11C\\]WAY 100635 BP = Distribution Volume (DV)ROI-DVcerebellum in striatal regions; subcortical regions including insula, medial temporal lobe, amygdala, hippocampus, midbrain, parahippocampal gyrus; and the neocortical regions (i.e., anterior cingulate cortex). Analysis of the PET data was performed using the Logan graphical method (Logan et al. 2001) with the cerebellum as a reference region for non-displaceable uptake. 23 REC AN were studied. The Binding Potential (BP) was calculated as followed: BPP = fP Bavail/KD = VT-VND;(Abbrev.: BPP = In vivo binding potential; fP = free fraction in plasma; Bavail = Density of receptors available to bind radioligand in vivo; KD = Dissociation Constant; V = Volumes of Distribution expressed relative to total plasma ligand concentration; T = Total radioligand in tissue; ND = Nondisplaceable tissue uptake; see Innis et al. 2007); Units: mL cm -3', 'unitOfMeasure': 'mL/cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants Recovered From Anorexia Before + After Fluoxetine', 'description': 'Participants recovered from anorexia\n\nFluoxetine: before 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '1/Recovered Anorevia', 'description': 'Recovered anorexia\n\nFluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '6.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2007-10-16', 'resultsFirstSubmitDate': '2016-01-25', 'studyFirstSubmitQcDate': '2008-01-26', 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-02', 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors', 'timeFrame': 'Baseline and 8 weeks', 'description': 'We used PET and \\[11C\\]WAY to assess 5-HT1A binding potential (BP) = \\[11C\\]WAY 100635 BP = Distribution Volume (DV)ROI-DVcerebellum in striatal regions; subcortical regions including insula, medial temporal lobe, amygdala, hippocampus, midbrain, parahippocampal gyrus; and the neocortical regions (i.e., anterior cingulate cortex). Analysis of the PET data was performed using the Logan graphical method (Logan et al. 2001) with the cerebellum as a reference region for non-displaceable uptake. 23 REC AN were studied. The Binding Potential (BP) was calculated as followed: BPP = fP Bavail/KD = VT-VND;(Abbrev.: BPP = In vivo binding potential; fP = free fraction in plasma; Bavail = Density of receptors available to bind radioligand in vivo; KD = Dissociation Constant; V = Volumes of Distribution expressed relative to total plasma ligand concentration; T = Total radioligand in tissue; ND = Nondisplaceable tissue uptake; see Innis et al. 2007); Units: mL cm -3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['eating disorders', 'anorexia nervosa', 'anorexia', 'PET', 'brain imaging', 'serotonin', 'fMRI', 'Prozac', 'fluoxetine'], 'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/15992780?ordinalpos=40&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Several studies in the past suggest that individuals who have or had anorexia nervosa may have alterations in brain serotonin. Serotonin seems to play an important role in regulating anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology called Positron Emission Tomography (PET), which is a method used to take pictures of the body, in this case, the brain. Study participants will undergo two baseline PET scans on the first day of the study. The women who have recovered from anorexia will then be given a medication called fluoxetine (also know as Prozac) to take for 8 weeks. At the end of the 8th week, they will return for a third PET scan. By comparing the brain scans, before and after fluoxetine treatment, we can understand more about how treatment with fluoxetine affects the serotonin receptors in the brain. We will be comparing brain serotonin system in women who have recovered from anorexia before and after medication in order to gain a better understanding of changes in the serotonin system associated with eating disorders. This study may help shed light on how to make fluoxetine a more effective treatment for anorexia nervosa.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recovered from Anorexia Nervosa\n* Not taking medication for emotional problems\n* Regular menstrual cycle\n\nExclusion Criteria:\n\n* Women who are pregnant or nursing\n* Psychoactive medications in the past 30 days\n* Neurological disorders.'}, 'identificationModule': {'nctId': 'NCT00603018', 'briefTitle': 'PET Imaging Study of Recovered Anorexics', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'PET Imaging of Dopaminergic Transmission and Serotonin Markers in Anorexia Nervosa', 'orgStudyIdInfo': {'id': 'PRO06110005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Annorexia nervosa', 'description': 'Participants recovered from anorexia nervosa before and after administration of fluoxetine', 'interventionNames': ['Drug: Fluoxetine']}], 'interventions': [{'name': 'Fluoxetine', 'type': 'DRUG', 'otherNames': ['Prozac'], 'description': '8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.', 'armGroupLabels': ['Annorexia nervosa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Walter Kaye, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD/Director, Eating Disorders Program Professor,', 'investigatorFullName': 'Walter Kaye', 'investigatorAffiliation': 'University of Pittsburgh'}}}}