{"protocolSection":{"identificationModule":{"nctId":"NCT01173055","orgStudyIdInfo":{"id":"MD-SAV-09"},"organization":{"fullName":"University of Michigan","class":"OTHER"},"briefTitle":"A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia","officialTitle":"A Randomized, Double-blind,Placebo-controlled, Two-way Crossover Study to Evaluate the Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging Activation Patterns in Patients With Fibromyalgia"},"statusModule":{"statusVerifiedDate":"2017-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-06"},"primaryCompletionDateStruct":{"date":"2012-06","type":"ACTUAL"},"completionDateStruct":{"date":"2012-06","type":"ACTUAL"},"studyFirstSubmitDate":"2010-07-29","studyFirstSubmitQcDate":"2010-07-29","studyFirstPostDateStruct":{"date":"2010-07-30","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-08-05","resultsFirstSubmitQcDate":"2015-02-03","resultsFirstPostDateStruct":{"date":"2015-02-20","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-10-04","lastUpdatePostDateStruct":{"date":"2017-11-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Daniel Clauw, MD","investigatorTitle":"Daniel Clauw, Professor of Anesthesiology, University of Michigan","investigatorAffiliation":"University of Michigan"},"leadSponsor":{"name":"University of Michigan","class":"OTHER"},"collaborators":[{"name":"Forest Laboratories","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Fibromyalgia is a condition that includes pain, tenderness, stiff muscle, and fatigue. Researchers want to find out if \"a drug\" called milnacipran can help people with fibromyalgia. milnacipran (Savella) is approved by the FDA for the management of fibromyalgia. In this study, milnacipran will be given to find out more about how it affects pain and thinking in people with fibromyalgia.","detailedDescription":"The objective of this study is to evaluate the effect of milnacipran on pain processing in patients with fibromyalgia and to assess the correlation between this effect and neural activation patterns during functional Magnetic Resonance Imaging (fMRI).\n\nNOTE regarding Changes in Outcome Measures\n\nIn this Crossover Study, participants were involved for approximately 16 weeks in this sequence: a week of preparing for the initial assessments, baseline measurements (Week 0), 6 weeks on placebo or study drug followed by measurements for effect of drug or placebo (Week 6); a week of titration off of drug, if appropriate (or continued placebo, if on placebo), two weeks of washout, a new baseline assessment (Week 9), six weeks of study drug (or placebo), another set of measurements for effect of drug or placebo (Week 15), and a final titration period to maintain masking of assignment to drug or placebo. Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable.\n\nWhen Outcome measure data was originally and accurately posted for baseline and change after treatment, the time frames listed were 0 and 15 weeks, because the last assessment was gathered at approximately week 15 for each person whose data is in the data set. However, given the crossover design, it seems more accurate and understandable, to show the time frame for the outcome measure as 6 because the participants were each administered drug or placebo for six weeks total. (Of course for the Placebo then Study Drug arm, the placebo data was collected at week 6, and for the Study Drug then Placebo arm, the drug data was collected at week 6, and similarly for the first group the drug data was collected at week 15 (first assignment, plus 1 week titration, 2 weeks washout, new baseline at week 9, and final collection at week 15), and for the second group the placebo data was collected at week 15.\n\nThus, outcome measures originally listed for 6 and 9 weeks, which were previously shown as \"Data Not Reported\" were effectively already included within the data presented for change from baseline shown in Week 15 in this fashion: 9 week data for the second assignment is part of the \"week 0 data\" for the first assignment, to get pre-treatment baseline for each treatment shown. Week 6 data is the post-treatment data which was shown as week 15, but is now recategorized as 6 week data. There is no, and never was, any data that could represent assignment to drug or placebo for 9 or 15 weeks.\n\nAdditionally, several outcome measures based on fMRI values were always listed in the protocol as other outcomes (not secondary outcomes), but had been incorrectly posted in the earlier listings on ClinicalTrials.gov. They have been accurately reclassified in the 2017 resubmission."},"conditionsModule":{"conditions":["Fibromyalgia"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":22,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Milnacipran","type":"EXPERIMENTAL","description":"Milnacipran will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.","interventionNames":["Drug: milnacipran"]},{"label":"Placebo","type":"EXPERIMENTAL","description":"Placebo will be given orally twice daily in tablet form at different times during the course of the study.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"milnacipran","description":"Milnacipran will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.","armGroupLabels":["Milnacipran"],"otherNames":["Savella"]},{"type":"DRUG","name":"Placebo","description":"Placebo will be given orally twice daily in tablet form at different times during the course of the study.","armGroupLabels":["Placebo"],"otherNames":["placebo/sugar pill"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pain Threshold at Baseline","description":"The primary outcome parameter is the medium pressure pain threshold at pre-treatment baseline (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale). Measured in kg/cm\\^2.","timeFrame":"Baselines measured at week 0 and week 9 after washout from first assignment to treatment"},{"measure":"Change in Pain Threshold From Baseline to End of Treatment.","description":"The primary outcome parameter is the change in medium pressure pain threshold (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale) from baseline to end of treatment. Measured in kg/cm\\^2. Lower values represent a worse outcome.","timeFrame":"baseline compared with 6 weeks of treatment"}],"secondaryOutcomes":[{"measure":"Diffuse Noxious Inhibitory Control (DNIC) Effect at Baseline.","description":"0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.","timeFrame":"Baselines measured at week 0 and week 9 after washout from first assignment to treatment"},{"measure":"Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.","description":"0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.","timeFrame":"baseline compared with 6 weeks of treatment"},{"measure":"Pain Tolerance at Baseline","description":"The primary outcome parameter is the pressure pain tolerance (maximum tolerated pressure) at pre-treatment baseline.","timeFrame":"Baselines measured at week 0 and week 9 after washout from first assignment to treatment"},{"measure":"Change in Pain Tolerance From Baseline to End of Treatment","description":"The primary outcome parameter is the change in pressure pain tolerance (maximum tolerated pressure) from baseline to end of treatment. Measured in kg/cm\\^2. Lower values represent a worse outcome.","timeFrame":"baseline compared wtih 6 weeks of treatment"}],"otherOutcomes":[{"measure":"Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to End of Treatment","timeFrame":"Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later"},{"measure":"Change in Descending Pain Modulation From Baseline to End of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)","timeFrame":"Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later"},{"measure":"Change in fMRI Activation Patterns During N-back Procedure From Baseline to End of Treatment.","timeFrame":"Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* You may be eligible to take part in this study if the following are true:\n\n  * You are between the age of 18 and 70 years\n  * If you are female\n  * If you are right handed\n  * You have a diagnosis of fibromyalgia for at least 3 months, as defined by the American College of Rheumatology 1990 Criteria\n  * You are willing to stop taking certain medicines that you may be taking on a regular basis. The researchers will discuss these medications with you in detail\n\nExclusion Criteria:\n\n* You may not be eligible take part in this study if any of the following are true for you:\n\n  * You have problems with your heart or cardiovascular system\n  * You have problems with your liver or kidneys\n  * You have an autoimmune disease, or a whole-body infection like HIV or hepatitis\n  * You have cancer\n  * You are pregnant or breastfeeding\n  * You abuse drugs or alcohol\n  * You have suicidal thoughts or wishes\n  * You have taken milnacipran or another study drug within the last 30 days\n  * You have a medical problem not listed here that would make it unsafe for you to take part in the study\n  * The research team feels that you will be unable to complete all phases of the study","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Daniel Clauw, MD","affiliation":"University of Michigan","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Michigan, Chronic Pain and Fatigue Research Center","city":"Ann Arbor","state":"Michigan","zip":"48106","country":"United States","geoPoint":{"lat":42.27756,"lon":-83.74088}}]},"referencesModule":{"references":[{"pmid":"33982890","type":"DERIVED","citation":"Ichesco E, Peltier SJ, Mawla I, Harper DE, Pauer L, Harte SE, Clauw DJ, Harris RE. Prediction of Differential Pharmacologic Response in Chronic Pain Using Functional Neuroimaging Biomarkers and a Support Vector Machine Algorithm: An Exploratory Study. Arthritis Rheumatol. 2021 Nov;73(11):2127-2137. doi: 10.1002/art.41781. Epub 2021 Sep 22."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants enrolled in the study received placebo for 1 week (Day -7 to 0) then began the double blinded treatment sequence.","groups":[{"id":"FG000","title":"Milnacipran First, Then Placebo","description":"Milnacipran then placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nMilnacipran First, Then Placebo: Period 1 (Day 1-49); Milnacipran 12.5mg by mouth (PO) Day 1; 12.5mg twice daily (BID) Day 2 to 3; 25mg BID Day 4 to 7; 50mg BID Day 8-14; 100mg BID Day 15-42 followed by taper Day 43-49 and a 14 day washout period. Then, placebo matching study treatment in similar pattern to Period 1 was administered beginning Period 2 (Day 64-112)."},{"id":"FG001","title":"Placebo First, Then Milnacipran","description":"Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nPlacebo First, Then Milnacipran: Period 1 (Day 1-49); Placebo matching study treatment was administered beginning Period 1 (Day 1-49) and a 14 day washout period. Then, Milnacipran Period 2 (Day 64-112); Milnacipran 12.5mg Day 62; 12.5mg twice daily (BID) Day 65 to 66; 25mg BID Day 67 to 70; 50mg BID Day 71-77; 100mg BID Day 78-105 followed by taper Day 106-112."}],"periods":[{"title":"Period 1 - Day 1 to 49","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"12"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}]}]},{"title":"Placebo Washout Period - Day 50 to 63","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Period 2 - Day 64 to 112","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The milnacipran then placebo arm was reduced from eight to six participants for the analysis due to tolerating a dose of Milnacipran less than 200mg/day. This was done to be consistent with the dosing of all other participants.","groups":[{"id":"BG000","title":"Milnacipran First, Then Placebo","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nmilnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."},{"id":"BG001","title":"Placebo First, Then Milnacipran","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nPlacebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"15"}]}],"measures":[{"title":"Age, Customized","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"title":"Fibromyalgia","categories":[{"measurements":[{"groupId":"BG000","value":"46.83","spread":"9.83"},{"groupId":"BG001","value":"36.67","spread":"8.64"},{"groupId":"BG002","value":"40.73","spread":"10.187"}]}]}]},{"title":"Sex/Gender, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Female","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"15"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"15"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pain Threshold at Baseline","description":"The primary outcome parameter is the medium pressure pain threshold at pre-treatment baseline (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale). Measured in kg/cm\\^2.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg/cm^2","timeFrame":"Baselines measured at week 0 and week 9 after washout from first assignment to treatment","groups":[{"id":"OG000","title":"Milnacipran","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nmilnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."},{"id":"OG001","title":"Placebo","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nPlacebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.7333","spread":".83166"},{"groupId":"OG001","value":"2.583","spread":".84339"}]}]}]},{"type":"PRIMARY","title":"Change in Pain Threshold From Baseline to End of Treatment.","description":"The primary outcome parameter is the change in medium pressure pain threshold (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale) from baseline to end of treatment. Measured in kg/cm\\^2. Lower values represent a worse outcome.","populationDescription":"Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg/cm^2","timeFrame":"baseline compared with 6 weeks of treatment","groups":[{"id":"OG000","title":"Milnacipran","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nmilnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."},{"id":"OG001","title":"Placebo","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nPlacebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"}]}],"classes":[{"title":"Pre-Treatment (Week 0 or 9)","categories":[{"measurements":[{"groupId":"OG000","value":"2.7333","spread":".83166"},{"groupId":"OG001","value":"2.583","spread":".84339"}]}]},{"title":"Post-Treatment (Week 6 or 15)","categories":[{"measurements":[{"groupId":"OG000","value":"2.650","spread":"1.05982"},{"groupId":"OG001","value":"2.70","spread":".99642"}]}]}]},{"type":"SECONDARY","title":"Diffuse Noxious Inhibitory Control (DNIC) Effect at Baseline.","description":"0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.","populationDescription":"One participant did not complete this outcome measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baselines measured at week 0 and week 9 after washout from first assignment to treatment","groups":[{"id":"OG000","title":"Milnacipran","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nmilnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."},{"id":"OG001","title":"Placebo","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nPlacebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"14"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.134","spread":"17.51978"},{"groupId":"OG001","value":"12.0240","spread":"20.80824"}]}]}]},{"type":"SECONDARY","title":"Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.","description":"0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.","populationDescription":"Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable. On the placebo, side one additional participant did not have data for this variable.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"baseline compared with 6 weeks of treatment","groups":[{"id":"OG000","title":"Milnacipran","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nmilnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."},{"id":"OG001","title":"Placebo","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nPlacebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"14"}]}],"classes":[{"title":"Pre-Treatment (Week 0 or 9)","categories":[{"measurements":[{"groupId":"OG000","value":"8.134","spread":"17.51978"},{"groupId":"OG001","value":"12.0240","spread":"20.80824"}]}]},{"title":"Post-Treatment (Week 6 or 15)","categories":[{"measurements":[{"groupId":"OG000","value":"11.0355","spread":"17.16822"},{"groupId":"OG001","value":"8.50","spread":"19.6678"}]}]}]},{"type":"SECONDARY","title":"Pain Tolerance at Baseline","description":"The primary outcome parameter is the pressure pain tolerance (maximum tolerated pressure) at pre-treatment baseline.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg/cm^2","timeFrame":"Baselines measured at week 0 and week 9 after washout from first assignment to treatment","groups":[{"id":"OG000","title":"Milnacipran","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nmilnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."},{"id":"OG001","title":"Placebo","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nPlacebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.2667","spread":"1.39983"},{"groupId":"OG001","value":"3.80","spread":"1.17716"}]}]}]},{"type":"SECONDARY","title":"Change in Pain Tolerance From Baseline to End of Treatment","description":"The primary outcome parameter is the change in pressure pain tolerance (maximum tolerated pressure) from baseline to end of treatment. Measured in kg/cm\\^2. Lower values represent a worse outcome.","populationDescription":"Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg/cm^2","timeFrame":"baseline compared wtih 6 weeks of treatment","groups":[{"id":"OG000","title":"Milnacipran","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nmilnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."},{"id":"OG001","title":"Placebo","description":"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.\n\nPlacebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"}]}],"classes":[{"title":"Pre-Treatment (Week 0 or 9)","categories":[{"measurements":[{"groupId":"OG000","value":"4.2667","spread":"1.39983"},{"groupId":"OG001","value":"3.80","spread":"1.17716"}]}]},{"title":"Post-Treatment (Week 6 or 15)","categories":[{"measurements":[{"groupId":"OG000","value":"3.8667","spread":"1.43261"},{"groupId":"OG001","value":"3.8667","spread":"1.20218"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to End of Treatment","reportingStatus":"NOT_POSTED","timeFrame":"Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later","denomUnitsSelected":"Participants"},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Descending Pain Modulation From Baseline to End of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)","reportingStatus":"NOT_POSTED","timeFrame":"Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later","denomUnitsSelected":"Participants"},{"type":"OTHER_PRE_SPECIFIED","title":"Change in fMRI Activation Patterns During N-back Procedure From Baseline to End of Treatment.","reportingStatus":"NOT_POSTED","timeFrame":"Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later","denomUnitsSelected":"Participants"}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"Milnacipran","description":"Milnacipran was given orally twice daily in tablet form at different times during the course of the study. 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