{"protocolSection":{"identificationModule":{"nctId":"NCT01145755","orgStudyIdInfo":{"id":"D0475C00020"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder","officialTitle":"A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Effectiveness and Safety of AZD2066 After 6 Weeks of Treatment in Patients With Major Depressive Disorder - D0475C00020"},"statusModule":{"statusVerifiedDate":"2012-09","overallStatus":"TERMINATED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-05"},"primaryCompletionDateStruct":{"date":"2010-11","type":"ACTUAL"},"completionDateStruct":{"date":"2010-11","type":"ACTUAL"},"studyFirstSubmitDate":"2010-05-27","studyFirstSubmitQcDate":"2010-06-16","studyFirstPostDateStruct":{"date":"2010-06-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-08-28","resultsFirstSubmitQcDate":"2012-08-28","resultsFirstPostDateStruct":{"date":"2012-09-27","type":"ESTIMATED"},"lastUpdateSubmitDate":"2012-09-27","lastUpdatePostDateStruct":{"date":"2012-10-03","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"}},"descriptionModule":{"briefSummary":"This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.","detailedDescription":"A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":131,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"AZD2066","type":"EXPERIMENTAL","interventionNames":["Drug: AZD2066"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]},{"label":"Duloxetine","type":"ACTIVE_COMPARATOR","description":"Duloxetine","interventionNames":["Drug: Duloxetine"]}],"interventions":[{"type":"DRUG","name":"AZD2066","description":"18 mg once daily","armGroupLabels":["AZD2066"]},{"type":"DRUG","name":"Placebo","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Duloxetine","description":"60 mg once daily","armGroupLabels":["Duloxetine"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"MADRS Total Score Change From Baseline to Week 6","description":"Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.","timeFrame":"6 weeks"}],"secondaryOutcomes":[{"measure":"MADRS Response","description":"A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.","timeFrame":"6 weeks"},{"measure":"MADRS Remission","description":"A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6","timeFrame":"6 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Provision of signed, written, and dated Informed Consent\n* Documented primary clinical diagnosis of Major Depressive Disorder\n\nExclusion Criteria:\n\n* Patients with a secondary psychiatric disorder including bipolar disorder, psychotic disorders (i.e. schizophrenia, schizoaffective disorder, depression with psychotic features), GAD and social anxiety disorder\n* Patients whose current episode of depression started less than 4 weeks before enrollment\n* History of inadequate response of antidepressants during current depressive episode","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Richard Malamut","affiliation":"AstraZeneca","role":"STUDY_CHAIR"},{"name":"Lora McGill","affiliation":"CNS Healthcare","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Research Site","city":"Garden Grove","state":"California","country":"United States","geoPoint":{"lat":33.77391,"lon":-117.94145}},{"facility":"Research Site","city":"San Diego","state":"California","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}},{"facility":"Research Site","city":"Jacksonville","state":"Florida","country":"United States","geoPoint":{"lat":30.33218,"lon":-81.65565}},{"facility":"Research Site","city":"Atlanta","state":"Georgia","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Research Site","city":"Rockville","state":"Maryland","country":"United States","geoPoint":{"lat":39.084,"lon":-77.15276}},{"facility":"Research Site","city":"Boston","state":"Massachusetts","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Research Site","city":"Cedarhurst","state":"New York","country":"United States","geoPoint":{"lat":40.62288,"lon":-73.7243}},{"facility":"Research Site","city":"Rochester","state":"New York","country":"United States","geoPoint":{"lat":43.15478,"lon":-77.61556}},{"facility":"Research Site","city":"Portland","state":"Oregon","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"Research Site","city":"Memphis","state":"Tennessee","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"facility":"Research Site","city":"Friendswood","state":"Texas","country":"United States","geoPoint":{"lat":29.5294,"lon":-95.20104}},{"facility":"Research Site","city":"Bellevue","state":"Washington","country":"United States","geoPoint":{"lat":47.61038,"lon":-122.20068}},{"facility":"Research Site","city":"Seattle","state":"Washington","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Patients with major depressive disorder were included.","recruitmentDetails":"This study was conducted only in the United States (US). A total of 13 study centers enrolled 249 patients. First subject enrolled: 27 May 2010 Last subject last visit: 10 November 2010","groups":[{"id":"FG000","title":"AZD2066","description":"AZD2066 12 mg, 18 mg"},{"id":"FG001","title":"Duloxetine","description":"Duloxetine 30 mg, 60 mg"},{"id":"FG002","title":"Placebo","description":"Placebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"47"},{"groupId":"FG002","numSubjects":"44"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"19"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"28"},{"groupId":"FG002","numSubjects":"25"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Study Closure","reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"17"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Patient could not swollow medication","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Positive urine ethanol","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"AZD2066","description":"AZD2066 12 mg, 18 mg"},{"id":"BG001","title":"Duloxetine","description":"Duloxetine 30 mg, 60 mg"},{"id":"BG002","title":"Placebo","description":"Placebo"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"44"},{"groupId":"BG003","value":"131"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"42.2","lowerLimit":"21","upperLimit":"60"},{"groupId":"BG001","value":"39.9","lowerLimit":"19","upperLimit":"60"},{"groupId":"BG002","value":"38.4","lowerLimit":"20","upperLimit":"61"},{"groupId":"BG003","value":"40.1","lowerLimit":"19","upperLimit":"60"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"77"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"54"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"MADRS Total Score Change From Baseline to Week 6","description":"Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on the scale","timeFrame":"6 weeks","groups":[{"id":"OG000","title":"AZD2066","description":"AZD2066 12 mg, 18 mg"},{"id":"OG001","title":"Duloxetine","description":"Duloxetine 30 mg, 60 mg"},{"id":"OG002","title":"Placebo","description":"Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.1658","spread":"2.11","lowerLimit":"NA","upperLimit":"NA"},{"groupId":"OG001","value":"-14.0271","spread":"1.97","lowerLimit":"NA","upperLimit":"NA"},{"groupId":"OG002","value":"-14.1575","spread":"2.16","lowerLimit":"NA","upperLimit":"NA"}]}]}]},{"type":"SECONDARY","title":"MADRS Response","description":"A MADRS 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presentation of results until the earlier of 1) the date of the first study results publication or 2) 18 months after completion or termination of the study.\n\nAZ review 60 days prior submission and AZ has the possibility to further delay publication for an additional 90 days"},"pointOfContact":{"title":"Gerard Lynch","organization":"AstraZeneca","email":"aztrial_results_posting@astrazeneca.com","phone":"645895","phoneExt":"+44 1509"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"C587779","term":"AZD2066"},{"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"}]}},"hasResults":true}