Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 9:16 PM
Study NCT ID:
NCT00304161
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2006-03-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'daniel.weintraub@uphs.upenn.edu', 'phone': '215-349-8207', 'title': 'Dr. Daniel Weintraub', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'First, the sample size was relatively small. Second, the diagnostic criteria for depression which are typically used in clinical trials were not used as an inclusion criterion. Third, antidepressant use at baseline was common in our population.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Atomoxetine', 'description': 'Participants will receive 40-80mgs of atomoxetine orally once daily.', 'otherNumAtRisk': 28, 'otherNumAffected': 7, 'seriousNumAtRisk': 28, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.', 'otherNumAtRisk': 27, 'otherNumAffected': 6, 'seriousNumAtRisk': 27, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Suicide Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Participants will receive 40-80mgs of atomoxetine orally once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology-Clinician Rated (IDS-C), a 30-item (scores 0-84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a \\>50% decrease in IDS-C score from baseline.', 'unitOfMeasure': 'percentage of improved participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression-Improvement Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': 'Participants will receive 40-80mgs of atomoxetine orally once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:\n\n1. = Very much improved\n2. = Much improved\n3. = Minimally improved\n4. = No change\n5. = Minimally worse\n6. = Much worse\n7. = Very much worse\n\nA participant scoring a 1 or 2 is considered a responder on the CGI scale.', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atomoxetine', 'description': 'Participants will receive 40-80mgs of atomoxetine orally once daily.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': "Patients were recruited from The Parkinson's Disease and Movement Disorders Center at Pennsylvania Hospital and the Parkinson's Disease Research, Education, and Clinical Center at the Philadelphia Veterans Affairs Medical Center between 2004-2009."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Atomoxetine', 'description': 'Participants will receive atomoxetine treatment'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants will receive placebo treatment'}, {'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': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.8', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '64.9', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '64.3', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-01', 'studyFirstSubmitDate': '2006-03-15', 'resultsFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2006-03-15', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-10', 'studyFirstPostDateStruct': {'date': '2006-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale', 'timeFrame': 'Week 8', 'description': 'The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology-Clinician Rated (IDS-C), a 30-item (scores 0-84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a \\>50% decrease in IDS-C score from baseline.'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression-Improvement Scale', 'timeFrame': 'Week 8', 'description': 'The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:\n\n1. = Very much improved\n2. = Much improved\n3. = Minimally improved\n4. = No change\n5. = Minimally worse\n6. = Much worse\n7. = Very much worse\n\nA participant scoring a 1 or 2 is considered a responder on the CGI scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', "Parkinson's Disease", 'Atomoxetine'], 'conditions': ['Depressive Disorder', 'Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '20679638', 'type': 'RESULT', 'citation': 'Weintraub D, Mavandadi S, Mamikonyan E, Siderowf AD, Duda JE, Hurtig HI, Colcher A, Horn SS, Nazem S, Ten Have TR, Stern MB. Atomoxetine for depression and other neuropsychiatric symptoms in Parkinson disease. Neurology. 2010 Aug 3;75(5):448-55. doi: 10.1212/WNL.0b013e3181ebdd79.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2918470/pdf/7887.pdf', 'label': 'Manuscript'}]}, 'descriptionModule': {'briefSummary': "This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.", 'detailedDescription': "Depression is a serious medical condition that affects people's thoughts, feelings, and ability to function in everyday life. Depression can happen to anyone, but it is more of a risk in people with Parkinson's disease, a progressive brain disorder that is caused by a loss of dopamine-producing brain cells. As many as half of people with Parkinson's may suffer from depression. These individuals experience different symptoms than those who have depression alone. For example, they are prone to higher rates of anxiety, sadness without guilt or self-blame, and lower suicide rates despite high rates of suicidal thoughts. Depression treatment can help people with Parkinson's disease who are depressed to manage both diseases and improve the quality of their lives. This study will evaluate the effectiveness of atomoxetine, an antidepressant medication, in reducing symptoms of depression in people with Parkinson's disease.\n\nParticipants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. All participants will report to the study site at baseline and Weeks 2, 4, and 8. Psychiatric, neuropsychological, and neurological assessments will be performed, including evaluations with the Inventory of Depressive Symptomatology (IDS) scale and the Clinical Global Impression-Improvement (CGI-I) scale. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's disease\n* IDS score greater than 21\n* Mini-Mental State Examination (MMSE) score greater than 15\n\nExclusion Criteria:\n\n* Recent deep brain stimulation\n* Currently participating in an antidepressant trial at a less than adequate dose and duration\n* Severe depression or depression with suicide ideation\n* History of liver toxicity\n* Unstable medical disease or comorbid psychiatric disease"}, 'identificationModule': {'nctId': 'NCT00304161', 'briefTitle': "Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Depression Diagnosis and Treatment in Parkinson Disease', 'orgStudyIdInfo': {'id': 'K23MH067894', 'link': 'https://reporter.nih.gov/quickSearch/K23MH067894', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K23MH067894', 'link': 'https://reporter.nih.gov/quickSearch/K23MH067894', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Atomoxetine', 'description': 'Participants will receive 40-80mgs of atomoxetine orally once daily.', 'interventionNames': ['Drug: Atomoxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atomoxetine', 'type': 'DRUG', 'otherNames': ['Straterra'], 'description': '40 to 80 mg orally once daily for 8 weeks', 'armGroupLabels': ['Atomoxetine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '40 to 80 mg orally once daily for 8 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Philadelphia Veterans Affairs Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Daniel Weintraub, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}