{"protocolSection":{"identificationModule":{"nctId":"NCT01337700","orgStudyIdInfo":{"id":"10-09-299"},"organization":{"fullName":"Montefiore Medical Center","class":"OTHER"},"briefTitle":"Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism","officialTitle":"Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism"},"statusModule":{"statusVerifiedDate":"2020-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-02"},"primaryCompletionDateStruct":{"date":"2014-07","type":"ACTUAL"},"completionDateStruct":{"date":"2014-07","type":"ACTUAL"},"studyFirstSubmitDate":"2010-12-27","studyFirstSubmitQcDate":"2011-04-18","studyFirstPostDateStruct":{"date":"2011-04-19","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-03-17","resultsFirstSubmitQcDate":"2020-02-13","resultsFirstPostDateStruct":{"date":"2020-02-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-02-13","lastUpdatePostDateStruct":{"date":"2020-02-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Eric Hollander","investigatorTitle":"Clinical Professor","investigatorAffiliation":"Montefiore Medical Center"},"leadSponsor":{"name":"Montefiore Medical Center","class":"OTHER"},"collaborators":[{"name":"Forest Laboratories","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very substantial costs associated with caring for patients with ASD, and ASD has the highest Caregiver Burden Scores of any condition. There are three core symptom domains of ASD, including social deficits, repetitive behaviors and language deficits. Patients can also have associated symptoms of attentional deficits, disruptive behaviors and intellectual disability. There is currently no Food and Drug administration (FDA) approved treatment for the core symptoms of autism, but risperidone and aripiprazole have FDA approval for disruptive behaviors associated with autism.\n\nThis is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a role in behavior adaptations and performance."},"conditionsModule":{"conditions":["Autism Spectrum Disorder","Asperger Syndrome","Aspergers Syndrome"],"keywords":["ASD","Autism","Autism Spectrum Disorder","Asperger Syndrome","Asperger","PDD","PDD-NOS"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":10,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Milnacipran","type":"EXPERIMENTAL","interventionNames":["Drug: Milnacipran"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Milnacipran","description":"Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile.","armGroupLabels":["Milnacipran"],"otherNames":["Savella"]},{"type":"DRUG","name":"Placebo","description":"Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale","description":"Change will be measured in each subject's score on the Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale from baseline through study end (week 12).Higher values represent a worse outcome.\n\nThe raw scores are converted to T-scores for each scale and sub-scale which are then compared against the mean. Higher values represent a worse outcome. A T-score of 50 is the mean of a relevant reference population. A T-score above 65 indicates a moderate to severe problem. For example, Row 1 is the mean of baseline T-scores for the Inattention/ Memory subscale and Row 2 is the mean of week 12 T-scores for the Inattention/ Memory subscale. The difference between these two means is used to measure the change from baseline through week 12 for both the groups.","timeFrame":"Baseline and Week 12 scores"},{"measure":"Change in Hyperactivity as Measured by Aberrant Behavior Checklist - Hyperactivity Scale","description":"The Aberrant Behavior Checklist is an informant-based questionnaire consisting of 58 items subdivided amongst 5 scales: irritability, lethargy and social withdrawal, stereotypic behavior, hyperactivity/non-compliance, and inappropriate speech \\[34\\]. A score for each item ranges from 0 indicating \"no problem\" to 3 indicating \"severe problem\". Scale scores are calculated by summing the items within that scale. Higher scores indicate greater impairment.Reported Data is for change in ABC-H from baseline to endpoint (week 0 to week 12).This data is specifically looking at the hyperactivity scale which is 16 items with each item ranging from 0-3 making total scores 0-48.","timeFrame":"Baseline to Endpoint - 12 weeks"}],"secondaryOutcomes":[{"measure":"Change in Autism Severity Levels Based on the Clinical Global Impressions Scale","description":"The CGI-I reflects the rater's impression of the subject's current autism severity on a 7-point scale ranging from Much Improved (1) to Much worse (5).","timeFrame":"screening, baseline, weeks 2,4,6,8,10,12"},{"measure":"Change in Repetitive Behaviors Using YBOCS-Compulsion and Rigidity Subscale","description":"This scale has been shown to be a sensitive outcome measure in autism trials of repetitive behaviors. Data for secondary outcome not analyzed due to lack of significance in primary outcomes measured.\n\n* scale range: 0 - 40 total, 0 - 7 subclinical, 8-15 mild, 16 - 23 moderate, 24 - 31 severe, 32 - 40 extreme\n* score interpretation: Higher overall scores reflect increasing symptom severity.","timeFrame":"baseline, weeks 2,4,6,8,10,12"},{"measure":"Change in Diagnostic Analysis of Nonverbal Activity-2 ADULT FACIAL EXPRESSIONS: (DANVA2-AF)","description":"This scale is shown to be sensitive to change in adults with autism, and related to amygdala function. Higher scores mean a better outcome.A clinical tool measuring emotion recognition through facial expression, voice and posture.\n\n1. Child faces 2 (range 0 - 100, higher values reflecting higher % of errors)\n2. Adult faces 2 (range 0 - 100, higher values reflecting higher % of errors)\n3. Child paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors)\n4. Adult paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors) Errors are counted and organized by pre-determined affect and intensity. Subtests considered separately.","timeFrame":"baseline, weeks 2,4,6,8,10,12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male and Female patients\n* Aged 18-50 years\n* Diagnosis of Autism Spectrum Disorder\n* intelligence quotient greater than 70\n\nExclusion Criteria:\n\n* Pregnant subjects\n* Patients deemed by comprehensive psychiatric interview to have a significant risk of suicide","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"50 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Eric Hollander, MD","affiliation":"Montefiore Medical Center/Albert Einstein College of Medicine","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Montefiore Medical Center, Albert Einstein College of Medicine","city":"The Bronx","state":"New York","zip":"10467","country":"United States","geoPoint":{"lat":40.84985,"lon":-73.86641}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Milnacipran","description":"Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile."},{"id":"FG001","title":"Placebo","description":"Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Milnacipran","description":"Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile."},{"id":"BG001","title":"Placebo","description":"Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"10"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"9"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"25","spread":"3.391"},{"groupId":"BG001","value":"25.2","spread":"9.149"},{"groupId":"BG002","value":"25.10","spread":"6.506"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"10"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"10"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Severity of Illness","description":"Scores are using the Clinical Global Impression Scale -Severity (CGI-S). This is a 7-point scale, from 1 (normal not at all ill) to 7 (among the most extremely ill), that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4","lowerLimit":"4","upperLimit":"4"},{"groupId":"BG001","value":"5","lowerLimit":"5","upperLimit":"5"},{"groupId":"BG002","value":"4.5","lowerLimit":"4","upperLimit":"5"}]}]}]},{"title":"Aberrant Behavior Checklist - Hyperactivity Scale (ABC-H)","description":"ABC-H can assess problematic behavior at home, in educational and work settings, and in residential and community-based facilities specifically in regard to hyperactivity. It is a sub- scale of the larger ABC-2 which rates 58 specific symptoms, and provides comprehensive descriptions, for each assessed behavior. It is further divided into five sub-scales and the one discussed here is hyperactivity. Each question is rated on a scale from 0-3 with 0 being not problematic and 3 being most problematic.","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19","lowerLimit":"8.45","upperLimit":"29.55"},{"groupId":"BG001","value":"9.8","lowerLimit":"3.91","upperLimit":"15.69"},{"groupId":"BG002","value":"14.4","lowerLimit":"3.91","upperLimit":"29.55"}]}]}]},{"title":"CAARS Inattention/Memory T Score","description":"The Conners Adult ADHD Rating Scales (CAARS) are the international standard for questionnaire assessment of ADHD. The raw scores are converted to T-scores for each scale and sub-scale which are then compared against the mean. This sub-scale being assessed is inattention/ memory. Higher values represent a worse outcome. A T-score of 50 is the mean of a relevant reference population. A T-score above 65 indicates a moderate to severe problem.","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"T score","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"68.6","lowerLimit":"53.77","upperLimit":"83.43"},{"groupId":"BG001","value":"71.8","lowerLimit":"65.99","upperLimit":"77.6"},{"groupId":"BG002","value":"70.2","lowerLimit":"53.77","upperLimit":"83.43"}]}]}]},{"title":"CAARS Hyperactivity/Restlessness T Score","description":"The Conners Adult ADHD Rating Scales (CAARS) are the international standard for questionnaire assessment of ADHD. The raw scores are converted to T-scores for each scale and sub-scale which are then compared against the mean. Higher values represent a worse outcome. A T-score of 50 is the mean of a relevant reference population. A T-score above 65 indicates a moderate to severe problem.This sub-scale being assessed is hyperactivity/ restlessness.","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"T score","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55","lowerLimit":"42.37","upperLimit":"67.63"},{"groupId":"BG001","value":"50.8","lowerLimit":"49.24","upperLimit":"59.56"},{"groupId":"BG002","value":"52.9","lowerLimit":"42.37","upperLimit":"67.63"}]}]}]},{"title":"CAARS Impulsivity/Emotional Labiality T Score","description":"The Conners Adult ADHD Rating Scales (CAARS) are the international standard for questionnaire assessment of ADHD. The raw scores are converted to T-scores for each scale and sub-scale which are then compared against the mean. Higher values represent a worse outcome. A T-score of 50 is the mean of a relevant reference population. A T-score above 65 indicates a moderate to severe problem.This sub-scale being assessed is impulsivity/ emotional labiality.","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"T score","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55.2","lowerLimit":"47.54","upperLimit":"62.86"},{"groupId":"BG001","value":"49.2","lowerLimit":"43.31","upperLimit":"55.09"},{"groupId":"BG002","value":"52.2","lowerLimit":"43.31","upperLimit":"62.86"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale","description":"Change will be measured in each subject's score on the Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale from baseline through study end (week 12).Higher values represent a worse outcome.\n\nThe raw scores are converted to T-scores for each scale and sub-scale which are then compared against the mean. Higher values represent a worse outcome. A T-score of 50 is the mean of a relevant reference population. A T-score above 65 indicates a moderate to severe problem. For example, Row 1 is the mean of baseline T-scores for the Inattention/ Memory subscale and Row 2 is the mean of week 12 T-scores for the Inattention/ Memory subscale. The difference between these two means is used to measure the change from baseline through week 12 for both the groups.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"T-score","timeFrame":"Baseline and Week 12 scores","groups":[{"id":"OG000","title":"Milnacipran","description":"Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 200mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile."},{"id":"OG001","title":"Placebo","description":"Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"}]}],"classes":[{"title":"Baseline: T-SCORES- Inattention/Memory","categories":[{"measurements":[{"groupId":"OG000","value":"68.6","spread":"14.83"},{"groupId":"OG001","value":"71.8","spread":"5.81"}]}]},{"title":"Week 12: T-SCORES- Inattention/Memory","categories":[{"measurements":[{"groupId":"OG000","value":"53.4","spread":"13.05"},{"groupId":"OG001","value":"57","spread":"20.22"}]}]},{"title":"Baseline: T-SCORES- Hyperactivity/Restlessness","categories":[{"measurements":[{"groupId":"OG000","value":"55","spread":"12.63"},{"groupId":"OG001","value":"50.8","spread":"8.76"}]}]},{"title":"Week 12:T-SCORES -Hyperactivity/Restlessness","categories":[{"measurements":[{"groupId":"OG000","value":"44.8","spread":"8.76"},{"groupId":"OG001","value":"39.8","spread":"7.56"}]}]},{"title":"Baseline: T-SCORES- Impulsivity/Emotional Lability","categories":[{"measurements":[{"groupId":"OG000","value":"55.2","spread":"7.66"},{"groupId":"OG001","value":"49.2","spread":"5.89"}]}]},{"title":"Week 12: T-SCORES- Impulsivity/Emotional Lability","categories":[{"measurements":[{"groupId":"OG000","value":"47.8","spread":"6.22"},{"groupId":"OG001","value":"43.6","spread":"13.90"}]}]}]},{"type":"PRIMARY","title":"Change in Hyperactivity as Measured by Aberrant Behavior Checklist - Hyperactivity Scale","description":"The Aberrant Behavior Checklist is an informant-based questionnaire consisting of 58 items subdivided amongst 5 scales: irritability, lethargy and social withdrawal, stereotypic behavior, hyperactivity/non-compliance, and inappropriate speech \\[34\\]. A score for each item ranges from 0 indicating \"no problem\" to 3 indicating \"severe problem\". Scale scores are calculated by summing the items within that scale. Higher scores indicate greater impairment.Reported Data is for change in ABC-H from baseline to endpoint (week 0 to week 12).This data is specifically looking at the hyperactivity scale which is 16 items with each item ranging from 0-3 making total scores 0-48.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline to Endpoint - 12 weeks","groups":[{"id":"OG000","title":"Milnacipran","description":"Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 200mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile."},{"id":"OG001","title":"Placebo","description":"Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-10.4","spread":"12.46"},{"groupId":"OG001","value":"-4.2","spread":"7.26"}]}]}]},{"type":"SECONDARY","title":"Change in Autism Severity Levels Based on the Clinical Global Impressions Scale","description":"The CGI-I reflects the rater's impression of the subject's current autism severity on a 7-point scale ranging from Much Improved (1) to Much worse (5).","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"screening, baseline, weeks 2,4,6,8,10,12","groups":[{"id":"OG000","title":"Milnacipran","description":"Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 200mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile."},{"id":"OG001","title":"Placebo","description":"Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"}]}],"classes":[{"title":"Much Improved","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}]},{"title":"Minimally Improved","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}]},{"title":"No Change","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}]}]},{"title":"Minimally Worse","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Much Worse","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change in Repetitive Behaviors Using YBOCS-Compulsion and Rigidity Subscale","description":"This scale has been shown to be a sensitive outcome measure in autism trials of repetitive behaviors. Data for secondary outcome not analyzed due to lack of significance in primary outcomes measured.\n\n* scale range: 0 - 40 total, 0 - 7 subclinical, 8-15 mild, 16 - 23 moderate, 24 - 31 severe, 32 - 40 extreme\n* score interpretation: Higher overall scores reflect increasing symptom severity.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"baseline, weeks 2,4,6,8,10,12","groups":[{"id":"OG000","title":"Milnacipran","description":"Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 200mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile."},{"id":"OG001","title":"Placebo","description":"Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"12.2","spread":"5.45"},{"groupId":"OG001","value":"12","spread":"2.75"}]}]},{"title":"Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"10","spread":"6.16"},{"groupId":"OG001","value":"12.2","spread":"1.32"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"11.6","spread":"5.08"},{"groupId":"OG001","value":"13.2","spread":"3.12"}]}]},{"title":"Week 6","categories":[{"measurements":[{"groupId":"OG000","value":"11.8","spread":"4.12"},{"groupId":"OG001","value":"12","spread":"1.79"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"10.4","spread":"3.93"},{"groupId":"OG001","value":"9.8","spread":"4.99"}]}]},{"title":"Week 10","categories":[{"measurements":[{"groupId":"OG000","value":"11.6","spread":"4.03"},{"groupId":"OG001","value":"12.8","spread":"1.17"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"12.4","spread":"4.41"},{"groupId":"OG001","value":"12","spread":"3.03"}]}]}]},{"type":"SECONDARY","title":"Change in Diagnostic Analysis of Nonverbal Activity-2 ADULT FACIAL EXPRESSIONS: (DANVA2-AF)","description":"This scale is shown to be sensitive to change in adults with autism, and related to amygdala function. Higher scores mean a better outcome.A clinical tool measuring emotion recognition through facial expression, voice and posture.\n\n1. Child faces 2 (range 0 - 100, higher values reflecting higher % of errors)\n2. Adult faces 2 (range 0 - 100, higher values reflecting higher % of errors)\n3. Child paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors)\n4. Adult paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors) Errors are counted and organized by pre-determined affect and intensity. Subtests considered separately.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"baseline, weeks 2,4,6,8,10,12","groups":[{"id":"OG000","title":"Milnacipran","description":"Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 200mg a day over the 12 week study period. 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