{"protocolSection":{"identificationModule":{"nctId":"NCT04218123","orgStudyIdInfo":{"id":"00091200"},"organization":{"fullName":"Medical University of South Carolina","class":"OTHER"},"briefTitle":"Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes","officialTitle":"Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes"},"statusModule":{"statusVerifiedDate":"2024-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-02-05","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-09-13","type":"ACTUAL"},"completionDateStruct":{"date":"2023-09-14","type":"ACTUAL"},"studyFirstSubmitDate":"2019-12-30","studyFirstSubmitQcDate":"2020-01-02","studyFirstPostDateStruct":{"date":"2020-01-06","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-03-28","resultsFirstSubmitQcDate":"2024-06-20","resultsFirstPostDateStruct":{"date":"2024-06-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-06-27","lastUpdatePostDateStruct":{"date":"2024-07-23","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Habib Rizk,MD","investigatorTitle":"Associate Professor","investigatorAffiliation":"Medical University of South Carolina"},"leadSponsor":{"name":"Medical University of South Carolina","class":"OTHER"},"collaborators":[{"name":"American Hearing Research Foundation","class":"OTHER"},{"name":"Cures Within Reach","class":"OTHER"}]},"oversightModule":{"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"As of yet, the cause of Meniere's disease is uncertain and there is no cure. Given the lack of high level evidence for treatments, we seek to perform a randomized, placebo-controlled, double-blind, crossover, pilot trial of venlafaxine for treating Meniere's disease. Venlafaxine is a safe and well-tolerated medication. It has never been trialed in Meniere's disease, but there is evidence that it could be effective in helping with vertigo attacks and other aspects of the disorder."},"conditionsModule":{"conditions":["Meniere Disease"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":40,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Venlafaxine Arm","type":"EXPERIMENTAL","interventionNames":["Drug: Venlafaxine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo oral tablet"]}],"interventions":[{"type":"DRUG","name":"Venlafaxine","description":"Daily oral intake 37.5 mg","armGroupLabels":["Venlafaxine Arm"]},{"type":"DRUG","name":"Placebo oral tablet","description":"Daily oral intake","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Vertigo Episodes","description":"Patients will be keeping a diary throughout the study period and beyond.","timeFrame":"6 months"},{"measure":"Severity of Vertigo","description":"The study team will use a modified version of vertigo control classification because the treatment phases are 2 months long and the study team will not be able to wait 18-24 months after treatment to assess efficacy per academy guidelines. Previous studies have defined four categories of response to treatment: 1) very good response if more than 75% reduction in vertigo spells frequency and/or intensity, 2) good response if 50-75% reduction, 3) fair response if 25-50% reduction, and 4) poor response if less than 25% reduction.\n\nThe vertigo classes will be defined as follows; Class A: 0 (complete control of vertigo) Class B: 0-40 or \\>60% reduction in mean vertigo episode severity (good control of vertigo) Class C: 41-80 or 20-60% reduction in severity (fair control of vertigo) Class D: 81-120 or -20-20% reduction in severity (no change in vertigo) Class E: \\>120 or \\>20% worsening in severity (worse vertigo)","timeFrame":"6 months"}],"secondaryOutcomes":[{"measure":"Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey","description":"The Medical Outcomes Study 20-item Short Form Health Survey is a 20-item general health questionnaire to assess quality of life in chronic diseases. It assesses 6 areas of health: physical functioning, role functioning, social functioning, mental health, health perceptions, and pain. Each score ranges between 0 and 100, with 100 indicating best possible function and 0 the worst possible function.","timeFrame":"Baseline to end of treatment (6 months)"},{"measure":"Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI)","description":"The Meniere's Disease Patient-Oriented Symptom Index is a 23-item survey developed as a MD-specific tool to assess the impact of MD symptoms on patients' lives. The score ranges from 0 to 100 with the higher score indicating an active disease with significant impact on function and quality of life.","timeFrame":"Baseline to end of treatment (6 months)"},{"measure":"Change in Score on Penn State Worry Questionnaire (PSWQ)","description":"The PSWQ is a 16-item survey for assessment of anxiety which has been used to identify generalized anxiety disorder. Scores range from 16 (Low worry) to 80 (high worry). A score higher than 60 is indicative of significant anxiety and risk for an anxiety disorder","timeFrame":"Baseline to end of treatment (6 months)"},{"measure":"Change in Score on Patient Health Questionnaire (PHQ9)","description":"The Patient Health Questionnaire is a 9-item survey which assesses the severity of depression. A low score is indicative of little to no depressive symptoms, and a high score is indicative of Moderately severe to severe depressive symptoms. Scores range from 0 to 27 with scores higher than 20 indicative of significant risk for depression and scores below 10 indicative at most of a mild depression.","timeFrame":"Baseline to end of treatment (6 months)"},{"measure":"Change in Score on Cognitive Failure Questionnaire (CFQ)","description":"The Cognitive Failure Questionnaire is a 25-item survey which assesses cognitive and executive function not tied to any specific disease state. It aims to assess perception, memory, and motor function in everyday tasks.The score ranges from 0 to 100 The higher score on the CFQ, the more frequent the cognitive failures experienced by the subject","timeFrame":"Baseline to end of treatment (6 months)"},{"measure":"Change in Score on Neuropsychological Vertigo Inventory (NVI)","description":"The English version of the Neuropsychological Vertigo Inventory consists of 28-items with a 5-point Likert scale for each question. It is a cognitive assessment specific to patients with dizziness. The NVI assesses 7 domains of cognition: space perception, attention, time perception, memory, emotional, visual/ocular and motor. The score ranges from 0 to 140. The higher the score on the NVI the worse the cognitive function of the subject.","timeFrame":"Baseline to end of treatment (6 months)"},{"measure":"Change in Score on Dizziness Handicap Inventory (DHI)","description":"The Dizziness Handicap Inventory is a 25-item questionnaire of self-perceived handicap from dizziness.There are 7 questions in the physical domain, 9 in the emotional domain, and 8 in the functional domain. It is scored from 0 (no perceived disability) to 100 (maximum perceived disability).","timeFrame":"Baseline to end of treatment (6 months)"}]},"eligibilityModule":{"eligibilityCriteria":"Study subjects will be prospectively recruited from the population of patients presenting with dizziness to our tertiary, multidisciplinary, vestibular-focused, neurotology clinic. Subjects must meet the following inclusion criteria:\n\n* be 18 years of age or older;\n* have definite MD as defined by the Barany Society 2015 international consensus statement;\n* have active MD with at least 2 vertigo episodes in the month prior to enrollment; and score at least 36 on the Dizziness Handicap Inventory (DHI), representing at least moderate handicap.\n\nPatients with the following will be excluded:\n\n* other concurrent vestibular or balance disorder (especially those with vestibular migraine-related vertigo episodes despite not meeting diagnostic criteria for vestibular migraine);\n* currently taking venlafaxine, SSRIs, or SNRIs;\n* history of medical (e.g. gentamicin) or surgical (e.g. labyrinthectomy) vestibular ablative treatment;\n* history of otologic, lateral skull base, or brain surgery;\n* history of radiation to the head or neck;\n* known neurologic disorder affecting cognition;\n* currently taking another serotonin modulating medication;\n* seizures;\n* stroke;\n* myocardial infarction;\n* hepatic or renal impairment;\n* hyperlipidemia;\n* coagulopathy;\n* psychiatric disorder other than anxiety or depression;\n* glaucoma;\n* uncontrolled hypertension;\n* pregnancy or intention of pregnancy.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Habib Rizk, MD","affiliation":"Medical University of South Carolina","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Medical Univeristy of South Carolina","city":"Charleston","state":"South Carolina","zip":"29425","country":"United States","geoPoint":{"lat":32.77632,"lon":-79.93275}}]},"referencesModule":{"references":[{"pmid":"39235772","type":"DERIVED","citation":"Rizk H, Monaghan NP, Shah S, Liu Y, Keith BA, Jeong S, Nguyen SA. Efficacy of a Serotonin-Norepinephrine Reuptake Inhibitor as a Treatment for Meniere Disease: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Nov 1;150(11):935-942. doi: 10.1001/jamaoto.2024.2241."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Venlafaxine, Then Placebo","description":"Venlafaxine 37.5mg tablet by mouth once daily in first 8 week period and placebo tablet by mouth once daily in the second 8 week period."},{"id":"FG001","title":"Placebo, Then Venlafaxine","description":"Placebo tablet by mouth once daily in first 8 week period and venlafaxine 37.5mg tablet by mouth once daily in the second 8 week period."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Venlafaxine, Then Placebo","description":"Venlafaxine 37.5mg tablet by mouth once daily in first 8 week period and placebo tablet by mouth once daily in the second 8 week period."},{"id":"BG001","title":"Placebo, Then Venlafaxine","description":"Placebo tablet by mouth once daily in first 8 week period and venlafaxine 37.5mg tablet by mouth once daily in the second 8 week period."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"40"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54.9","spread":"17.2"},{"groupId":"BG001","value":"58.3","spread":"11"},{"groupId":"BG002","value":"56.6","spread":"14.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"18"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"22"}]}]}]},{"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":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"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":"5"},{"groupId":"BG002","value":"7"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"32"}]},{"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":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"40"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Vertigo Episodes","description":"Patients will be keeping a diary throughout the study period and beyond.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"number of episodes","timeFrame":"6 months","groups":[{"id":"OG000","title":"Venlafaxine Arm","description":"Venlafaxine 37.5 mg tablet by mouth once daily"},{"id":"OG001","title":"Placebo Arm","description":"Placebo tablet by mouth once daily"},{"id":"OG002","title":"Baseline Score","description":"Baseline score upon enrollment in the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.41","spread":"4.44"},{"groupId":"OG001","value":"5.03","spread":"4.57"},{"groupId":"OG002","value":"13.78","spread":"10.05"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value \\<0.05 required to be considered nonequivalent","pValue":"<0.001","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value of \\<0.05 required for result to be considered nonequivalent","pValue":"<0.05","statisticalMethod":"ANOVA","statisticalComment":"Anova Post Hoc Analysis"},{"groupIds":["OG001","OG002"],"nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value of \\<0.05 required for result to be considered nonequivalent","pValue":"<0.05","statisticalMethod":"ANOVA","statisticalComment":"Anova Post Hoc Analysis"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value of \\<0.05 required for result to be considered nonequivalent","pValue":">0.05","statisticalMethod":"ANOVA","statisticalComment":"Anova Post Hoc Analysis"}]},{"type":"PRIMARY","title":"Severity of Vertigo","description":"The study team will use a modified version of vertigo control classification because the treatment phases are 2 months long and the study team will not be able to wait 18-24 months after treatment to assess efficacy per academy guidelines. Previous studies have defined four categories of response to treatment: 1) very good response if more than 75% reduction in vertigo spells frequency and/or intensity, 2) good response if 50-75% reduction, 3) fair response if 25-50% reduction, and 4) poor response if less than 25% reduction.\n\nThe vertigo classes will be defined as follows; Class A: 0 (complete control of vertigo) Class B: 0-40 or \\>60% reduction in mean vertigo episode severity (good control of vertigo) Class C: 41-80 or 20-60% reduction in severity (fair control of vertigo) Class D: 81-120 or -20-20% reduction in severity (no change in vertigo) Class E: \\>120 or \\>20% worsening in severity (worse vertigo)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of members in arm","timeFrame":"6 months","groups":[{"id":"OG000","title":"Venlafaxine Arm","description":"Venlafaxine: Daily oral intake 37.5 mg"},{"id":"OG001","title":"Placebo","description":"Placebo oral tablet: Daily oral intake"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"}]}],"classes":[{"title":"Class A Control","categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"24"}]}]},{"title":"Class B Control","categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"32"}]}]},{"title":"Class C Control","categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"32"}]}]},{"title":"Class D Control","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"}]}]},{"title":"Class E Control","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"9"}]}]}]},{"type":"SECONDARY","title":"Change in Score on The Medical Outcomes Study 20-item Short Form Health Survey","description":"The Medical Outcomes Study 20-item Short Form Health Survey is a 20-item general health questionnaire to assess quality of life in chronic diseases. It assesses 6 areas of health: physical functioning, role functioning, social functioning, mental health, health perceptions, and pain. Each score ranges between 0 and 100, with 100 indicating best possible function and 0 the worst possible function.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline to end of treatment (6 months)","groups":[{"id":"OG000","title":"Venlafaxine Arm","description":"Venlafaxine 37.5 mg tablet by mouth once daily"},{"id":"OG001","title":"Placebo Arm","description":"Placebo tablet by mouth once daily"},{"id":"OG002","title":"Baseline Score","description":"Baseline score upon enrollment in the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"40"}]}],"classes":[{"title":"Physical Functioning","categories":[{"measurements":[{"groupId":"OG000","value":"14.92","spread":"3.34"},{"groupId":"OG001","value":"14.54","spread":"3.42"},{"groupId":"OG002","value":"13.81","spread":"3.6"}]}]},{"title":"Role Functioning","categories":[{"measurements":[{"groupId":"OG000","value":"4.62","spread":"1.62"},{"groupId":"OG001","value":"4.6","spread":"1.61"},{"groupId":"OG002","value":"4.38","spread":"1.52"}]}]},{"title":"Mental Health","categories":[{"measurements":[{"groupId":"OG000","value":"22.24","spread":"6.79"},{"groupId":"OG001","value":"22","spread":"5.95"},{"groupId":"OG002","value":"20.95","spread":"6.06"}]}]},{"title":"Social Functioning","categories":[{"measurements":[{"groupId":"OG000","value":"4.38","spread":"1.67"},{"groupId":"OG001","value":"4.54","spread":"1.44"},{"groupId":"OG002","value":"3.84","spread":"1.44"}]}]},{"title":"Health Perceptions","categories":[{"measurements":[{"groupId":"OG000","value":"16.95","spread":"4.91"},{"groupId":"OG001","value":"16.17","spread":"5.46"},{"groupId":"OG002","value":"15.07","spread":"5.1"}]}]},{"title":"Pain","categories":[{"measurements":[{"groupId":"OG000","value":"2.6","spread":"1.44"},{"groupId":"OG001","value":"2.74","spread":"1.42"},{"groupId":"OG002","value":"2.76","spread":"1.52"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"SF20 Physical Functioning","nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value \\<0.05 required to be considered nonequivalent","pValue":"=0.31","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"SF20 Role Functioning","nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value of \\<0.05 required for result to be considered nonequivalent","pValue":"0.633","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"SF20 Mental Health","nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value of \\<0.05 required for result to be considered nonequivalent","pValue":"0.424","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"SF20 Social Functioning","nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value of \\<0.05 required for result to be considered nonequivalent","pValue":"0.057","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"SF20 Health Perceptions","nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value of \\<0.05 required for result to be considered nonequivalent","pValue":"0.296","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"SF20 Pain","nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value of \\<0.05 required for result to be considered nonequivalent","pValue":"0.872","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Change in Score on The Meniere's Disease Patient-Oriented Symptom Index (MDPOSI)","description":"The Meniere's Disease Patient-Oriented Symptom Index is a 23-item survey developed as a MD-specific tool to assess the impact of MD symptoms on patients' lives. The score ranges from 0 to 100 with the higher score indicating an active disease with significant impact on function and quality of life.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline to end of treatment (6 months)","groups":[{"id":"OG000","title":"Venlafaxine Arm","description":"Venlafaxine 37.5 mg tablet by mouth once daily"},{"id":"OG001","title":"Placebo Arm","description":"Placebo tablet by mouth once daily"},{"id":"OG002","title":"Baseline Score","description":"Baseline score upon enrollment in the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"46.81","spread":"15.59"},{"groupId":"OG001","value":"46.31","spread":"16.32"},{"groupId":"OG002","value":"50.68","spread":"13.66"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value \\<0.05 required to be considered nonequivalent","pValue":"=0.538","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Change in Score on Penn State Worry Questionnaire (PSWQ)","description":"The PSWQ is a 16-item survey for assessment of anxiety which has been used to identify generalized anxiety disorder. Scores range from 16 (Low worry) to 80 (high worry). A score higher than 60 is indicative of significant anxiety and risk for an anxiety disorder","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline to end of treatment (6 months)","groups":[{"id":"OG000","title":"Venlafaxine Arm","description":"Venlafaxine 37.5 mg tablet by mouth once daily"},{"id":"OG001","title":"Placebo Arm","description":"Placebo tablet by mouth once daily"},{"id":"OG002","title":"Baseline Score","description":"Baseline score upon enrollment in the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"44.35","spread":"14.36"},{"groupId":"OG001","value":"45.63","spread":"13.48"},{"groupId":"OG002","value":"47.16","spread":"14.11"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value \\<0.05 required to be considered nonequivalent","pValue":"=0.686","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Change in Score on Patient Health Questionnaire (PHQ9)","description":"The Patient Health Questionnaire is a 9-item survey which assesses the severity of depression. A low score is indicative of little to no depressive symptoms, and a high score is indicative of Moderately severe to severe depressive symptoms. Scores range from 0 to 27 with scores higher than 20 indicative of significant risk for depression and scores below 10 indicative at most of a mild depression.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline to end of treatment (6 months)","groups":[{"id":"OG000","title":"Venlafaxine Arm","description":"Venlafaxine 37.5 mg tablet by mouth once daily"},{"id":"OG001","title":"Placebo Arm","description":"Placebo tablet by mouth once daily"},{"id":"OG002","title":"Baseline Score","description":"Baseline score upon enrollment in the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.49","spread":"5.27"},{"groupId":"OG001","value":"7.17","spread":"5.73"},{"groupId":"OG002","value":"7.43","spread":"5.32"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value \\<0.05 required to be considered nonequivalent","pValue":"=0.167","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Change in Score on Cognitive Failure Questionnaire (CFQ)","description":"The Cognitive Failure Questionnaire is a 25-item survey which assesses cognitive and executive function not tied to any specific disease state. It aims to assess perception, memory, and motor function in everyday tasks.The score ranges from 0 to 100 The higher score on the CFQ, the more frequent the cognitive failures experienced by the subject","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"Baseline to end of treatment (6 months)","groups":[{"id":"OG000","title":"Venlafaxine Arm","description":"Venlafaxine 37.5 mg tablet by mouth once daily"},{"id":"OG001","title":"Placebo Arm","description":"Placebo tablet by mouth once daily"},{"id":"OG002","title":"Baseline Score","description":"Baseline score upon enrollment in the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33.92","spread":"16.35"},{"groupId":"OG001","value":"36.4","spread":"17.63"},{"groupId":"OG002","value":"36.14","spread":"18.18"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"p value \\<0.05 required to be considered nonequivalent","pValue":"=0.8","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Change in Score on Neuropsychological Vertigo Inventory (NVI)","description":"The English version of the Neuropsychological Vertigo Inventory consists of 28-items with a 5-point Likert scale for each question. 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