{"protocolSection":{"identificationModule":{"nctId":"NCT00831415","orgStudyIdInfo":{"id":"3151A1-3350"},"secondaryIdInfos":[{"id":"B2061002"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)","officialTitle":"A 10-Month Open-Label Evaluation Of The Long-Term Safety Of Desvenlafaxine Succinate Sustained Release In Japanese Adults With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2018-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-03"},"primaryCompletionDateStruct":{"date":"2011-03","type":"ACTUAL"},"completionDateStruct":{"date":"2011-03","type":"ACTUAL"},"studyFirstSubmitDate":"2009-01-27","studyFirstSubmitQcDate":"2009-01-28","studyFirstPostDateStruct":{"date":"2009-01-29","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-12-22","resultsFirstSubmitQcDate":"2011-12-22","resultsFirstPostDateStruct":{"date":"2012-01-30","type":"ESTIMATED"},"lastUpdateSubmitDate":"2018-11-15","lastUpdatePostDateStruct":{"date":"2018-12-07","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of Japanese subjects with major depressive disorder (MDD).\n\nThe secondary objective is to evaluate the long-term response of subjects receiving desvenlafaxine succinate sustained release tablets by clinical global evaluation, general well-being and absence of symptoms."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Open-label Long-term extension study"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":304,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1","type":"EXPERIMENTAL","description":"DVS SR","interventionNames":["Drug: desvenlafaxine succinate sustained release tablets"]}],"interventions":[{"type":"DRUG","name":"desvenlafaxine succinate sustained release tablets","description":"25-mg or 50-mg DVS SR tablets taken orally, once daily, at the same time each day. 100 mg dose will be supplied as 2 tablets of 50-mg tablet.","armGroupLabels":["1"],"otherNames":["DVS-233; Pristiq"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. FOT evaluation is defined as the last \"on-therapy\" evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit.","timeFrame":"Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation"},{"measure":"Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)","description":"Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.","timeFrame":"Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment"}],"secondaryOutcomes":[{"measure":"Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)","description":"CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.","timeFrame":"Day 308 or FOT Evaluation"},{"measure":"Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score","description":"CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.","timeFrame":"Baseline (Extension Study) up to Day 308 or FOT Evaluation"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Outpatients who have completed double-blind therapy in short-term study for the indication of major depressive disorder (MDD), including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.\n\nExclusion Criteria:\n\n* Clinically important abnormalities on baseline (day 56 of the short-term study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before day 56 in the previous short-term study for the indication of MDD.","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Pfizer Investigational Site","city":"Aichi","country":"Japan","geoPoint":{"lat":32.51879,"lon":130.62158}},{"facility":"Pfizer Investigational Site","city":"Chiba","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"Pfizer Investigational Site","city":"Fukuoka","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"Pfizer Investigational Site","city":"Fukushima","country":"Japan","geoPoint":{"lat":37.75,"lon":140.46667}},{"facility":"Pfizer Investigational Site","city":"Gunma","country":"Japan"},{"facility":"Pfizer Investigational Site","city":"Hiroshima","country":"Japan","geoPoint":{"lat":34.4,"lon":132.45}},{"facility":"Pfizer Investigational Site","city":"Hokkaido","country":"Japan"},{"facility":"Pfizer Investigational Site","city":"Hyōgo","country":"Japan","geoPoint":{"lat":43.36667,"lon":144.43333}},{"facility":"Pfizer Investigational Site","city":"Ishikawa","country":"Japan","geoPoint":{"lat":26.42333,"lon":127.82139}},{"facility":"Pfizer Investigational Site","city":"Kanagawa","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"Pfizer Investigational Site","city":"Kumamoto","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"Pfizer Investigational Site","city":"Kyoto","country":"Japan","geoPoint":{"lat":35.02107,"lon":135.75385}},{"facility":"Pfizer Investigational Site","city":"Osaka","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"Pfizer Investigational Site","city":"Saga","country":"Japan","geoPoint":{"lat":33.23333,"lon":130.3}},{"facility":"Pfizer Investigational Site","city":"Saitama","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"Pfizer Investigational Site","city":"Shiga","country":"Japan","geoPoint":{"lat":36.02247,"lon":138.13005}},{"facility":"Pfizer Investigational Site","city":"Tokyo","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}}]},"referencesModule":{"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-3350"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 304 participants who completed the short-term Core Study (NCT00798707 \\[3151A1-3359 / B2061003\\]) consented to enroll in this long-term, open-label, flexible dosing Extension study (NCT00831415 \\[3151A1-3350 / B2061002\\]). Baseline in this Extension study = Day 56 of the Core study.","recruitmentDetails":"This was a 10-month, open-label, multicenter study of Japanese participants with Major Depressive Disorder (MDD) conducted from March 2009 to March 2011 at 61 sites in Japan.","groups":[{"id":"FG000","title":"DVS SR","description":"Desvenlafaxine succinate sustained release formulation (DVS SR) flexible dose 25 milligrams per day (mg/day) up to 100 mg/day."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"304"}]},{"type":"Completers for \"Exposure\"","achievements":[{"groupId":"FG000","comment":"Participants with ≥ 301 days of exposure to study drug and completed study day 308 evaluations.","numSubjects":"227"}]},{"type":"Study \"Completers\"","achievements":[{"groupId":"FG000","comment":"Defined as participants whose conclusion of study participation status was \"study completed.\"","numSubjects":"227"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"In addition to Completers for Study includes 2 participants who discontinued after on-therapy period","numSubjects":"229"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"75"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"14"}]},{"type":"Failed to return","reasons":[{"groupId":"FG000","numSubjects":"3"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"6"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"9"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"35"}]},{"type":"Unsatisfactory response - Efficacy","reasons":[{"groupId":"FG000","numSubjects":"4"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"DVS SR","description":"DVS SR flexible dose 25 mg/day up to 100 mg/day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"304"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"38.45","spread":"10.81"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"149"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"155"}]}]}]},{"title":"Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) score","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. 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Baseline for CGI-I in this Extension study (NCT00831415 \\[3151A1-3350 / B2061002\\]) was measured against CGI-I baseline (Day -1) data in Core study (NCT00798707 \\[3151A1-3359 / B2061003\\]).","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"1=Very much improved","categories":[{"measurements":[{"groupId":"BG000","value":"75"}]}]},{"title":"2=Much improved","categories":[{"measurements":[{"groupId":"BG000","value":"81"}]}]},{"title":"3=Minimally improved","categories":[{"measurements":[{"groupId":"BG000","value":"94"}]}]},{"title":"4=No change","categories":[{"measurements":[{"groupId":"BG000","value":"51"}]}]},{"title":"5=Minimally worse","categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}]}]},{"title":"Clinical Global Impression-Severity of Illness [CGI-S] score","description":"CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3.25","spread":"1.11"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. FOT evaluation is defined as the last \"on-therapy\" evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit.","populationDescription":"Intent to treat (ITT): all enrolled participants who received at least 1 dose of study treatment in Extension Study and at least 1 available post-baseline evaluation for any endpoint; (n)=number of participants with analyzable data at observation.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"scores on a scale","timeFrame":"Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation","groups":[{"id":"OG000","title":"DVS SR","description":"DVS SR flexible dose 25 mg/day up to 100 mg/day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"}]}],"classes":[{"title":"LOCF - change at FOT (n=304)","categories":[{"measurements":[{"groupId":"OG000","value":"-4.76","lowerLimit":"-5.47","upperLimit":"-4.05"}]}]},{"title":"Observed cases - change at Day 308 (n=224)","categories":[{"measurements":[{"groupId":"OG000","value":"-5.82","lowerLimit":"-6.61","upperLimit":"-5.03"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)","description":"CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). 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Improvement measured against CGI-I baseline (Day -1) data in Core study (NCT00798707 \\[3151A1-3359 / B2061003\\]).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Day 308 or FOT Evaluation","groups":[{"id":"OG000","title":"DVS SR","description":"DVS SR flexible dose 25 mg/day up to 100 mg/day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"304"}]}],"classes":[{"title":"1=Very much improved","categories":[{"measurements":[{"groupId":"OG000","value":"164"}]}]},{"title":"2=Much improved","categories":[{"measurements":[{"groupId":"OG000","value":"82"}]}]},{"title":"3=Minimally improved","categories":[{"measurements":[{"groupId":"OG000","value":"36"}]}]},{"title":"4=No change","categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}]},{"title":"5=Minimally worse","categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]},{"title":"6=Much worse","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"7=Very much worse","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score","description":"CGI-S is a 7-point clinician rated scale to assess severity of current illness state. 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