{"protocolSection":{"identificationModule":{"nctId":"NCT01020799","orgStudyIdInfo":{"id":"D1151C00005"},"organization":{"fullName":"AstraZeneca","class":"INDUSTRY"},"briefTitle":"AZD7268 Safety and Tolerability Study","officialTitle":"A Phase II, Multi-center, Randomized, Double-bind, Double-dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of AZD7268 in Patients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2012-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-11"},"primaryCompletionDateStruct":{"date":"2010-04","type":"ACTUAL"},"completionDateStruct":{"date":"2010-04","type":"ACTUAL"},"studyFirstSubmitDate":"2009-11-25","studyFirstSubmitQcDate":"2009-11-25","studyFirstPostDateStruct":{"date":"2009-11-26","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-01-11","resultsFirstSubmitQcDate":"2012-03-15","resultsFirstPostDateStruct":{"date":"2012-04-10","type":"ESTIMATED"},"lastUpdateSubmitDate":"2012-04-11","lastUpdatePostDateStruct":{"date":"2012-04-17","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"AstraZeneca","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo."},"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":247,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"AZD7268","type":"EXPERIMENTAL","description":"The AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only.","interventionNames":["Drug: AZD7268","Drug: Placebo tablets"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"The placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in the morning and evening. In addition, 2 placebos to match encapsulated escitalopram tablets were dosed orally in the morning only.","interventionNames":["Drug: Placebo capsules","Drug: Placebo tablets"]},{"label":"Escitalopram","type":"ACTIVE_COMPARATOR","description":"The escitalopram 20 mg QD arm consisted of 3 placebo to match AZD7268 capsules dosed orally in the morning and evening. In addition, during Week 1, one encapsulated 10-mg escitalopram tablet and 1 placebo to match encapsulated escitalopram tablet were dosed orally in the morning only. During Weeks 2 through 4, two encapsulated 10-mg escitalopram tablets were dosed orally in the morning only.","interventionNames":["Drug: Escitalopram","Drug: Placebo capsules"]}],"interventions":[{"type":"DRUG","name":"AZD7268","description":"15 mg, oral, twice daily (BID)","armGroupLabels":["AZD7268"]},{"type":"DRUG","name":"Escitalopram","description":"20 mg, oral, once daily (QD)","armGroupLabels":["Escitalopram"]},{"type":"DRUG","name":"Placebo capsules","description":"Placebo capsules to match AZD7268","armGroupLabels":["Escitalopram","Placebo"]},{"type":"DRUG","name":"Placebo tablets","description":"Placebo tablets to match encapsulated escitalopram","armGroupLabels":["AZD7268","Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.","description":"MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. \\[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\\]","timeFrame":"Baseline, Week 4"}],"secondaryOutcomes":[{"measure":"Montgomery-Åsberg Depression Rating Scale (MADRS) Response","description":"Number of patients with MADRS response at Week 4. MADRS response is defined as \\>=50% reduction in MADRS total score from baseline. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). \\[Full Analysis Set (FAS)\\]","timeFrame":"Week 4"},{"measure":"Montgomery-Åsberg Depression Rating Scale (MADRS) Remission","description":"Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score \\<= 10. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). \\[Full Analysis Set (FAS)\\]","timeFrame":"Week 4"},{"measure":"Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.","description":"HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. \\[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\\]","timeFrame":"Baseline, Week 4"},{"measure":"Clinical Global Impression - Severity (CGI-S) Score Change From Baseline","description":"CGI-S assesses global illness severity, i.e. the patient's current clinical state, on a continuous scale from 1 (\"Normal, not ill\") to 7 (\"Among the most extremely ill patients\"). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. \\[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\\]","timeFrame":"Baseline, Week 4"},{"measure":"Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline","description":"HAM-A total score, sum of 14 item scores (each on a 0 to 4 scale), assesses the severity of anxiety symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. \\[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\\]","timeFrame":"Baseline, Week 4"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Provision of signed, written, and dated Informed Consent prior to any study specific procedures\n* Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following:\n* 296.2x Major Depressive Disorder, Single Episode, or\n* 296.3x Major Depressive Disorder, Recurrent\n\nExclusion Criteria:\n\n* Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxiety disorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosis should have been made at least 6 months before enrollment\n* Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status\n* Patients whose current episode of depression started less than 4 weeks before enrollment","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Research Site","city":"Birmingham","state":"Alabama","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"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":"New Haven","state":"Connecticut","country":"United States","geoPoint":{"lat":41.30815,"lon":-72.92816}},{"facility":"Research Site","city":"Bradenton","state":"Florida","country":"United States","geoPoint":{"lat":27.49893,"lon":-82.57482}},{"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":"Cedarhurst","state":"New York","country":"United States","geoPoint":{"lat":40.62288,"lon":-73.7243}},{"facility":"Research Site","city":"New York","state":"New York","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Research Site","city":"Rochester","state":"New York","country":"United States","geoPoint":{"lat":43.15478,"lon":-77.61556}},{"facility":"Research Site","city":"Dayton","state":"Ohio","country":"United States","geoPoint":{"lat":39.75895,"lon":-84.19161}},{"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 were required to discontinue current treatment for MDD at least 7 days prior to randomization (14 days prior to Day 1 for monoamine oxidase inhibitors \\[MAOIs\\] and 28 days prior to Day 1 for fluoxetine). Patients not taking medications for MDD at enrollment could be randomized once eligibility was confirmed.","recruitmentDetails":"A total of 18 centers were inititated with first patient enrolled on 16 November 2009 and last patient completed on 15 April 2010. A total of 430 patients were enrolled with 247 qualified patients allocated to randomized treatment.","groups":[{"id":"FG000","title":"AZD7268","description":"AZD7268 15 mg twice per day (BID), placebo matching escitalopram"},{"id":"FG001","title":"Placebo","description":"Placebo matching both AZD7268 and escitalopram"},{"id":"FG002","title":"Escitalopram","description":"Escitalopram 20 mg once per day(QD) Placebo matching AZD7268"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"98"},{"groupId":"FG001","numSubjects":"99"},{"groupId":"FG002","numSubjects":"50"}]},{"type":"Patients Received Treatment","achievements":[{"groupId":"FG000","numSubjects":"96"},{"groupId":"FG001","numSubjects":"99"},{"groupId":"FG002","numSubjects":"50"}]},{"type":"Full Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"91"},{"groupId":"FG001","numSubjects":"94"},{"groupId":"FG002","numSubjects":"49"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"79"},{"groupId":"FG001","numSubjects":"85"},{"groupId":"FG002","numSubjects":"43"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"7"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"non-compliance; lack of efficacy; etc.","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"AZD7268","description":"AZD7268 15 mg twice per day (BID), placebo matching escitalopram"},{"id":"BG001","title":"Placebo","description":"Placebo matching both AZD7268 and escitalopram"},{"id":"BG002","title":"Escitalopram","description":"Escitalopram 20 mg once per day(QD) Placebo matching AZD7268"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"98"},{"groupId":"BG001","value":"99"},{"groupId":"BG002","value":"50"},{"groupId":"BG003","value":"247"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39.29","spread":"11.63"},{"groupId":"BG001","value":"41.77","spread":"10.02"},{"groupId":"BG002","value":"36.22","spread":"11.29"},{"groupId":"BG003","value":"39.09","spread":"10.98"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"108"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"61"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"139"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"66"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"34"},{"groupId":"BG003","value":"156"}]}]},{"title":"Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"35"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"77"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"5"}]}]},{"title":"Native Hawaiian or other Pacific Islander","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}]}]},{"title":"American Indian or Alaska Native","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"6"}]}]}]},{"title":"Montgomery-Åsberg Depression Rating Scale (MADRS) total score at baseline","description":"MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). \\[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\\]","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"30.9","spread":"3.9"},{"groupId":"BG001","value":"31.4","spread":"4.2"},{"groupId":"BG002","value":"30.8","spread":"4.0"},{"groupId":"BG003","value":"31.03","spread":"4.03"}]}]}]},{"title":"Hamilton Rating Scale for Depression (HAM-D) total score at baseline","description":"HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). \\[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\\]","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"scores on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"24.3","spread":"2.9"},{"groupId":"BG001","value":"24.6","spread":"2.8"},{"groupId":"BG002","value":"24.4","spread":"2.8"},{"groupId":"BG003","value":"24.43","spread":"2.83"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.","description":"MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. \\[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\\]","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline, Week 4","groups":[{"id":"OG000","title":"AZD7268","description":"AZD7268 15 mg twice per day (BID), placebo matching escitalopram"},{"id":"OG001","title":"Placebo","description":"Placebo matching both AZD7268 and escitalopram"},{"id":"OG002","title":"Escitalopram","description":"Escitalopram 20 mg once per day(QD) Placebo matching AZD7268"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"94"},{"groupId":"OG002","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.78","spread":"1.13","lowerLimit":"1.13"},{"groupId":"OG001","value":"-11.45","spread":"1.05","lowerLimit":"1.05"},{"groupId":"OG002","value":"-11.70","spread":"1.57","lowerLimit":"1.57"}]}]}]},{"type":"SECONDARY","title":"Montgomery-Åsberg Depression Rating Scale (MADRS) Response","description":"Number of patients with MADRS response at Week 4. MADRS response is defined as \\>=50% reduction in MADRS total score from baseline. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). \\[Full Analysis Set (FAS)\\]","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 4","groups":[{"id":"OG000","title":"AZD7268","description":"AZD7268 15 mg twice per day (BID), placebo matching escitalopram"},{"id":"OG001","title":"Placebo","description":"Placebo matching both AZD7268 and escitalopram"},{"id":"OG002","title":"Escitalopram","description":"Escitalopram 20 mg once per day(QD) Placebo matching AZD7268"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"94"},{"groupId":"OG002","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"14"}]}]}]},{"type":"SECONDARY","title":"Montgomery-Åsberg Depression Rating Scale (MADRS) Remission","description":"Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score \\<= 10. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). \\[Full Analysis Set (FAS)\\]","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Week 4","groups":[{"id":"OG000","title":"AZD7268","description":"AZD7268 15 mg twice per day (BID), placebo matching escitalopram"},{"id":"OG001","title":"Placebo","description":"Placebo matching both AZD7268 and escitalopram"},{"id":"OG002","title":"Escitalopram","description":"Escitalopram 20 mg once per day(QD) Placebo matching AZD7268"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"94"},{"groupId":"OG002","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"10"}]}]}]},{"type":"SECONDARY","title":"Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.","description":"HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. \\[observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)\\]","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Baseline, Week 4","groups":[{"id":"OG000","title":"AZD7268","description":"AZD7268 15 mg twice per day (BID), placebo matching escitalopram"},{"id":"OG001","title":"Placebo","description":"Placebo matching both AZD7268 and escitalopram"},{"id":"OG002","title":"Escitalopram","description":"Escitalopram 20 mg once per day(QD) Placebo matching AZD7268"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"94"},{"groupId":"OG002","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-9.22","spread":"0.82","lowerLimit":"0.82"},{"groupId":"OG001","value":"-9.15","spread":"0.81","lowerLimit":"0.81"},{"groupId":"OG002","value":"-9.84","spread":"0.99","lowerLimit":"0.99"}]}]}]},{"type":"SECONDARY","title":"Clinical Global Impression - Severity (CGI-S) Score Change From Baseline","description":"CGI-S assesses global illness severity, i.e. the patient's current clinical state, on a continuous scale from 1 (\"Normal, not ill\") to 7 (\"Among the most extremely ill patients\"). 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