{"protocolSection":{"identificationModule":{"nctId":"NCT02674529","orgStudyIdInfo":{"id":"STUDY19070392/PRO16050131"},"organization":{"fullName":"University of Pittsburgh","class":"OTHER"},"briefTitle":"Study of Neural Responses Induced by Antidepressant Effects","officialTitle":"Study of Neural Responses Induced by Simulated Antidepressants","acronym":"SONRISA"},"statusModule":{"statusVerifiedDate":"2022-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-09","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-05","type":"ACTUAL"},"completionDateStruct":{"date":"2021-05","type":"ACTUAL"},"studyFirstSubmitDate":"2016-01-22","studyFirstSubmitQcDate":"2016-02-01","studyFirstPostDateStruct":{"date":"2016-02-04","type":"ESTIMATED"},"resultsFirstSubmitDate":"2022-06-23","resultsFirstSubmitQcDate":"2022-10-11","resultsFirstPostDateStruct":{"date":"2022-11-03","type":"ACTUAL"},"dispFirstSubmitDate":"2022-04-29","dispFirstSubmitQcDate":"2022-04-29","dispFirstPostDateStruct":{"date":"2022-05-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-10-11","lastUpdatePostDateStruct":{"date":"2022-11-03","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Marta Peciña, MD PhD","investigatorTitle":"Assistant Professor","investigatorAffiliation":"University of Pittsburgh"},"leadSponsor":{"name":"Marta Peciña, MD PhD","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The proposed work aims to examine the neural changes associated with fast-acting antidepressant treatments in order to develop imaging-based biomarkers of treatment response for depression.","detailedDescription":"Over the past decade, neuroimaging tools have rapidly advanced the field of neural biomarkers of treatment response in depression. Still, despite obvious scientific progress in this field, the ability to implement neuroimaging biomarkers of antidepressant treatment response in clinical trial settings is lacking. In order to objectively assess the neural bases of treatment response in depression, the investigators will use a \"Real-time Neurofeedback fMRI task\", specifically designed to record and modulate mood improvement by providing neurofeedback in the context of the administration of an antidepressant treatment. In a pilot study, positive neurofeedback during the administration of the drug was associated with significant acute mood improvement and increased blood oxygen level dependent (BOLD) responses in the rostral anterior cingulate cortex (rACC), a common neural target of antidepressant treatments. The central hypothesis is that antidepressant effects in depression are mediated by increased neural activity in the rACC (AIM1), which can be used in clinical trials of antidepressant treatment to predict antidepressant effects (AIM 2) and assess the effect of antidepressant treatment on antidepressant-induced rACC neural responses (AIM 3). The results obtained from this project are expected to have an important impact on our ability to understand the cognitive and neural mechanisms implicated in antidepressant treatment responses in patients with depression, as well as on the ability to implement neuroimaging biomarkers of treatment response in the clinical trial settings."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Depression","Neuroimaging biomarkers","MDD","Neurofeedback"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":60,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Antidepressant Treatment","type":"ACTIVE_COMPARATOR","description":"20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.","interventionNames":["Drug: Escitalopram","Behavioral: Real-time Neurofeedback fMRI task pre- and post-RCT"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"A placebo pill will be taken over an 8-week period.","interventionNames":["Drug: Placebo","Behavioral: Real-time Neurofeedback fMRI task pre- and post-RCT"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"Selective Serotonin Reuptake Inhibitor (SSRI)","armGroupLabels":["Antidepressant Treatment"],"otherNames":["Lexapro"]},{"type":"DRUG","name":"Placebo","description":"Placebo","armGroupLabels":["Placebo"]},{"type":"BEHAVIORAL","name":"Real-time Neurofeedback fMRI task pre- and post-RCT","description":"Placebo experiment during an fMRI scanning session","armGroupLabels":["Antidepressant Treatment","Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores","description":"The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale was.\\[2\\] There is, however, a high degree of statistical correlation between scores on the two measures.","timeFrame":"baseline and week 8"}],"secondaryOutcomes":[{"measure":"Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores","description":"The Quick Inventory of Depressive Symptomatology (QIDS) is a 16-item, self-reported measure of depression that ranges from 1 (no depression) to 27 (very severe depression).","timeFrame":"baseline and 8 weeks"},{"measure":"Neural Responses During the Sham Neurofeedback fMRI Task.","description":"Voxel-wise BOLD changes during the expectancy condition of the Sham Neurofeedback fMRI task.","timeFrame":"Baseline"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* A man or woman age of 18 or older.\n* Currently experiencing a depressive episode as part of Major Depressive Disorder.\n* Able to tolerate lying still on your back for 60 minutes at a time.\n* Have had no more than one failed antidepressant trial of adequate dose and duration.\n* Have been antidepressant medication-free for at least 21 days prior to collection of imaging data (5 weeks for fluoxetine)\n\nExclusion Criteria:\n\n* Are currently taking any psychiatric medication, or any potentially augmenting or sedative drugs.\n* Have a history of inadequate response/tolerability to escitalopram; or history of resistant depression\n* Pregnant or breastfeeding or plan to become pregnant over the duration of the study.\n* Have a history (lifetime) of psychotic depressive, schizophrenic, bipolar, schizoaffective, or other Axis I psychotic disorders.\n* Meet criteria for substance dependence in the last 6 months, except nicotine, or substance abuse in the last 2 months.\n* Have a medical condition that contradicts treatment with escitalopram.\n* Are currently receiving psychotherapy or any other treatment for your depression.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Marta Pecina, MD, PhD","affiliation":"University of Pittsburgh","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"WPIC","city":"Pittsburgh","state":"Pennsylvania","zip":"15213","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"The study will follow NIMH schedule for data sharing for clinical trials. The schedule allows for descriptive data to be submitted - but not shared - ongoing and results associated with a finding - both positive and negative - to be submitted prior to the communication of a result. Once a result is communicated, either through publication and/or on the NDCT website the data specifically defined to the clinical trial will then be shared."}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Six participants were excluded after enrollment for the following reasons: leaving the study site without informing study team, asking for extra-time to consider the study, feeling uncomfortable in the fMRI and asking to exit the scanner, testing positive for pregnancy tests, feeling indecisive, and not responding to contact attempts.","groups":[{"id":"FG000","title":"Antidepressant Treatment","description":"20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.\n\nEscitalopram: Selective Serotonin Reuptake Inhibitor (SSRI)"},{"id":"FG001","title":"Placebo","description":"A placebo pill will be taken over an 8-week period.\n\nPlacebo: Placebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"29"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"24"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Antidepressant Treatment","description":"20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.\n\nEscitalopram: Selective Serotonin Reuptake Inhibitor (SSRI)"},{"id":"BG001","title":"Placebo","description":"A placebo pill will be taken over an 8-week period.\n\nPlacebo: Placebo"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"54"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"54"}]},{"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":"25.44","spread":"6.33"},{"groupId":"BG001","value":"23.45","spread":"5.65"},{"groupId":"BG002","value":"24.18","spread":"5.76"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"46"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"52"}]},{"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":"4"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"10"}]},{"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":"2"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"10"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"29"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"5"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"54"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores","description":"The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale was.\\[2\\] There is, however, a high degree of statistical correlation between scores on the two measures.","populationDescription":"Scores can range from 0-60, with higher scores meaning greater the depression severity. The greater the change in MADRS scores from baseline, the better the outcome. 46 participants were analyzed, with 8 participants lost to follow up.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"baseline and week 8","groups":[{"id":"OG000","title":"Changes in MADRS Scores From Baseline to Week 8 Within the Antidepressant Treatment Arm","description":"20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.\n\nEscitalopram: Selective Serotonin Reuptake Inhibitor (SSRI)"},{"id":"OG001","title":"Changes in MADRS Scores From Baseline to Week 8 Within the Placebo Arm","description":"A placebo pill will be taken over an 8-week period.\n\nPlacebo: Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11","spread":"9"},{"groupId":"OG001","value":"12","spread":"9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","nonInferiorityComment":"This was a mechanistic trial and non-inferiority or equivalence analysis were not performed.","pValue":"0.58","statisticalMethod":"Regression, Linear","statisticalComment":"Drug (antidepressant vs. placebo) prediction of changes in mood as measured by the MADRS scores.","paramType":"regression coefficient","paramValue":"-1.29864","ciPctValue":"95","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"2.3"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.05","statisticalMethod":"Correlation","statisticalComment":"Change in MADRS after 8 weeks correlation with brain responses during the baseline fMRI task.","paramType":"r","paramValue":"0.02","ciNumSides":"TWO_SIDED"}]},{"type":"SECONDARY","title":"Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores","description":"The Quick Inventory of Depressive Symptomatology (QIDS) is a 16-item, self-reported measure of depression that ranges from 1 (no depression) to 27 (very severe depression).","populationDescription":"Scores can range from 0-27, with higher scores meaning greater the depression severity. The greater the change in QIDS scores from baseline to week 8, the better the outcome. 46 participants were analyzed, with 8 participants lost to follow up.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"baseline and 8 weeks","groups":[{"id":"OG000","title":"Changes in QIDS Scores From Baseline to Week 8 Within the Antidepressant Treatment Arm","description":"20mg of escitalopram will be taken over an 8-week period, starting with 10mg for the first week.\n\nEscitalopram: Selective Serotonin Reuptake Inhibitor (SSRI)"},{"id":"OG001","title":"Changes in QIDS Scores From Baseline to Week 8 Within the Placebo Arm","description":"A placebo pill will be taken over an 8-week period.\n\nPlacebo: Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.82","spread":"6.01"},{"groupId":"OG001","value":"5.54","spread":"5.45"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","nonInferiorityComment":"This is a mechanistic trial, we did not perform non-inferiority or equivalence analysis.","pValue":"0.8","statisticalMethod":"Regression, Linear","paramType":"regression coefficient","paramValue":"-1.4328918","ciPctValue":"95","ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_DEVIATION","dispersionValue":"1.4"}]},{"type":"SECONDARY","title":"Neural Responses During the Sham Neurofeedback fMRI Task.","description":"Voxel-wise BOLD changes during the expectancy condition of the Sham Neurofeedback fMRI task.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"BOLD signal change","timeFrame":"Baseline","groups":[{"id":"OG000","title":"Baseline fMRI Measures","description":"The primary objective is to define the neural correlates of placebo response in MDD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"54"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.1","lowerLimit":"0.47","upperLimit":"1.61"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"At the group-level, a random-effects analysis determines the main effects of the regressors of interest (e.g., high vs. low expectancy) resulting in statistical parametric maps (t or F statistics). 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