Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT00940693
Status:
COMPLETED
Last Update Posted:
2010-12-14
First Post:
2009-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-13', 'studyFirstSubmitDate': '2009-07-15', 'studyFirstSubmitQcDate': '2009-07-15', 'lastUpdatePostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Observer Report:Screening Version (CAARS-O:SV) in adult ADHD subjects.", 'timeFrame': 'baseline and week 6'}], 'secondaryOutcomes': [{'measure': 'Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults', 'timeFrame': 'baseline and week 6'}, {'measure': "Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report : Long Version(44) (CAARS-S:L), in adult ADHD subjects.", 'timeFrame': 'baseline and week 6'}, {'measure': 'Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects.', 'timeFrame': 'baseline and week 6'}, {'measure': 'Impact of duloxetine on Quality of life in adults with ADHD', 'timeFrame': 'baseline and week 6'}, {'measure': 'Impact of duloxetine on executive functions and cognitive performances in adults with ADHD', 'timeFrame': 'baseline and week 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Attention Deficit Disorder with Hyperactivity', 'Duloxetine', 'Adult', 'ADDH', 'ADHD'], 'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'referencesModule': {'references': [{'pmid': '19359667', 'type': 'BACKGROUND', 'citation': 'Tourjman SV, Bilodeau M. Improvement with duloxetine in an adult ADHD patient. J Atten Disord. 2009 Jul;13(1):95-6. doi: 10.1177/1087054708326109. Epub 2009 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether duloxetine is an effective treatment of attention deficit disorder in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of ADHD of at least moderate intensity\n* Able to give consent\n* Able to swallow capsules\n\nExclusion Criteria:\n\n* Allergic or do not tolerate duloxetine\n* Under psychotherapy for ADHD\n* Taking a medication that interacts with duloxetine, including all psychotropic medication\n* Treated with medication for ADHD\n* Unstable medical condition\n* Severe renal insufficiency\n* Liver insufficiency\n* Substance/alcool abuse or dependency in the last 6 months\n* Pregnancy, nursing or inadequate contraceptive methods\n* Suicide or homicide risk\n* Organic brain syndrome\n* Any diagnosis of lifetime bipolar disorder or psychotic disorder, and any actual diagnosis of anxious disorder or major depressive disorder'}, 'identificationModule': {'nctId': 'NCT00940693', 'briefTitle': 'Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)', 'organization': {'class': 'OTHER', 'fullName': 'Université de Montréal'}, 'officialTitle': 'Pilot Study of the Efficacy of Duloxetine in Treating Adults With Attention Deficit Hyperactivity Disorder: a Randomized, Controlled Trial.', 'orgStudyIdInfo': {'id': '09.008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'duloxetine', 'interventionNames': ['Drug: duloxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'duloxetine', 'type': 'DRUG', 'otherNames': ['cymbalta'], 'description': '60 mg capsule once per day for 6 weeks', 'armGroupLabels': ['duloxetine']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'one capsule of placebo taken one a day for 6 weeks', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Valérie Tourjman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Montréal', 'class': 'OTHER'}, 'collaborators': [{'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Smadar Valérie Tourjman', 'oldOrganization': 'Centre Hospitalier Universitaire de Montréal'}}}}