{"protocolSection":{"identificationModule":{"nctId":"NCT02389465","orgStudyIdInfo":{"id":"5R01MH098260-02","type":"NIH","link":"https://reporter.nih.gov/quickSearch/5R01MH098260-02"},"organization":{"fullName":"University of Pennsylvania","class":"OTHER"},"briefTitle":"Stress and Inflammation in Late-Life Depression","officialTitle":"Stress and Inflammation in the Pathophysiology of Late Life Depression","acronym":"S&I"},"statusModule":{"statusVerifiedDate":"2023-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-08"},"primaryCompletionDateStruct":{"date":"2022-07-18","type":"ACTUAL"},"completionDateStruct":{"date":"2022-07-18","type":"ACTUAL"},"studyFirstSubmitDate":"2015-02-27","studyFirstSubmitQcDate":"2015-03-16","studyFirstPostDateStruct":{"date":"2015-03-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2023-07-19","resultsFirstSubmitQcDate":"2023-09-18","resultsFirstPostDateStruct":{"date":"2023-10-02","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-09-18","lastUpdatePostDateStruct":{"date":"2023-10-02","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Pennsylvania","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Over 18% of Americans aged 65 years and older have depression. Recent evidence suggests that there is a link between depression and inflammatory disease. This study investigates the relationship between inflammation in the brain and depression. Comparing biological and psychological differences in depressed and non-depressed people allows researchers to find better ways to treat and prevent depression. All participants will have: neuropsychological tests, an EKG, a spinal tap, a blood draw, and, if depressed, given either an antidepressant coupled with an anti-inflammatory medication or an anti-depressant coupled with a placebo for six weeks. The investigators are trying to correlate brain function with depression levels and biomarkers from the blood and spinal fluid."},"conditionsModule":{"conditions":["Depression","Inflammation"],"keywords":["Depression","Geriatric","Inflammation"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":119,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Control","type":"NO_INTERVENTION","description":"This arm is for participants who are not depressed."},{"label":"Experimental - treatment","type":"EXPERIMENTAL","description":"Depressed participants will receive an antidepressant (escitalopram) AND either a non-steroidal anti-inflammatory drug (celecoxib) OR placebo (sugar pill) for 6 weeks.","interventionNames":["Drug: Escitalopram + Celecoxib","Drug: Escitalopram + Placebo"]}],"interventions":[{"type":"DRUG","name":"Escitalopram + Celecoxib","description":"Participants will receive celecoxib in addition to escitalopram","armGroupLabels":["Experimental - treatment"]},{"type":"DRUG","name":"Escitalopram + Placebo","description":"Participants will receive a placebo in addition to escitalopram.","armGroupLabels":["Experimental - treatment"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"IL-6 Levels","description":"IL6 levels were measured in participants by blood draw 6 weeks after the first dose was given.","timeFrame":"up to week 6"},{"measure":"Montgomery Asberg Depression Rating Scale (MADRS)","description":"This depression rating scale will be used to determine clinical outcome for depressed participants.\n\nScores range from 0-60. The higher the score, the worse the outcome (see below)\n\nNormal: 0-6 Mild Depression: 7-19 Moderate Depression: 20-34 Severe Depression: 35+ Very Severe Depression: 60","timeFrame":"Week 6"},{"measure":"IL10 Levels","description":"IL10 levels were measured in participants by blood draw 6 weeks after the first dose was given","timeFrame":"up to 6 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Age 18-80, male or female, any race;\n2. Absence of clinical dementia\n3. English speaking\n4. Blood pressure not exceeding 150/90 mmHg, treated or untreated\n5. Weight greater than 110 lbs\n6. Normal result on liver-function test\n7. No history of ulcer disease or GI bleeding\n8. No renal insufficiency\n\nAdditional Inclusion Criteria for Depressed Participants:\n\n1. DSM-IV criteria for Major Depressive Disorder\n2. HAM-D greater than 18\n\nExclusion Criteria:\n\n1. Known history of relevant severe drug allergy or hypersensitivity (e.g. to Citalopram or Escitalopram, and/or to celecoxib, aspirin, or other NSAIDs only for Phase 2; known demonstration of allergic-type reactions to sulfonamides);\n2. Does not speak English;\n3. Cannot give informed consent;\n4. MRI contraindications (e.g., foreign metallic implants, pacemaker);\n5. Known primary neurological disorders, such as Parkinson's disease, Alzheimer's disease, traumatic brain injury, cognitive impairment or dementia,\n6. Known severe inflammatory disease such as systemic lupus erythematosis, known autoimmune diseases, such as multiple sclerosis, rheumatoid arthritis; Screen + for RF, ANA, HIV, Hepatitis B or C.\n7. Clinical Dementia Rating Scale score greater than 0;\n8. Diagnosis of a chronic psychiatric illness other than MDD at the discretion of the study doctor;\n9. Significant handicaps (e.g. uncorrected hearing or visual impairment, mental retardation) that would interfere with testing;\n10. Bleeding diathesis;\n11. Severe Medical problem, which in the opinion of the investigator would pose a safety risk to the subject;\n12. Clinically significant cardiovascular disease that will be assessed on a case-by-case basis. Clinically significant cardiovascular disease usually includes one or more of the following: cardiac surgery or myocardial infarction within the last 4 weeks; unstable angina; acute decompensated congestive heart failure or class IV heart failure; current significant cardiac arrhythmia or conduction disturbance, particularly those resulting in ventricular fibrillation, or causing syncope or near syncope; uncontrolled high blood pressure; QTc greater than 450msec (by history for subjects with cardiac disease); documented prior stroke;\n13. Clinically significant abnormalities on EKG. Primary AV block or Right bundle branch block are not necessarily exclusionary;\n14. Current diagnosis of cancer\n15. Current diagnosis of HIV, active Hepatitis B and/or Hepatitis C\n16. Use of an Investigational medicine within the past 30 days;\n17. Use of Coumadin, Warfarin within the past 2 months;\n18. Current treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers, mood stabilizers, antipsychotics, steroids or non-steroidal anti-inflammatory medications or other antidepressants. No subjects will be included in the study unless they have been off all psychotropics for at least 3 weeks, except in the case of fluoxetine, where 5 weeks off treatment will be required;\n19. Current alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, or current OCD;\n20. Abnormal liver-function test\n21. History of ulcer disease, Chron's disease, GI bleeding or anemia\n22. Weight less than 110 lbs\n23. Renal insufficiency\n24. Any other factor that in the investigator's judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from this facility);\n\nAdditional Exclusion Criteria for Depressed Subjects:\n\n1\\) Active suicidality or current suicidal risk as determined by the investigator","healthyVolunteers":true,"sex":"ALL","minimumAge":"50 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Yvette Sheline","affiliation":"University of Pennsylvania","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","zip":"19104","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}}]},"referencesModule":{"references":[{"pmid":"35332134","type":"DERIVED","citation":"Luning Prak ET, Brooks T, Makhoul W, Beer JC, Zhao L, Girelli T, Skarke C, Sheline YI. No increase in inflammation in late-life major depression screened to exclude physical illness. Transl Psychiatry. 2022 Mar 24;12(1):118. doi: 10.1038/s41398-022-01883-4."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Total recruitment was 119 but 24 screen failed so the actual recruitment was 95","recruitmentDetails":"SEPTA and PATCO advertisements, radio advertisements on WHYY, WMGK, and WURD, Newspaper advertisements in Metro, Milestones, Golden Times, and Haddonfield Sun, recruitment flyers, iConnect, emailing doctors for referrals, and advertising in clinics","groups":[{"id":"FG000","title":"Healthy Control","description":"Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study"},{"id":"FG001","title":"Experimental - Placebo","description":"Participants meet DSM-IV criteria for MDD, and received placebo pills for the 6 week duration of the study"},{"id":"FG002","title":"Escitalopram","description":"Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study."},{"id":"FG003","title":"Escitalopram + Celecoxib","description":"Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"29"},{"groupId":"FG003","numSubjects":"16"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"24"},{"groupId":"FG003","numSubjects":"13"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Healthy Control","description":"Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study"},{"id":"BG001","title":"Placebo","description":"Participants meet DSM-IV criteria for MDD, and received placebo pills for the 6 week duration of the study"},{"id":"BG002","title":"Escitalopram","description":"Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study."},{"id":"BG003","title":"Escitalopram + Celecoxib","description":"Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study"},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"95"}]}],"measures":[{"title":"Age, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"18-55","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"95"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"26"}]}]},{"title":"56-65","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"95"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"42"}]}]},{"title":"66-75","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"95"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"22"}]}]},{"title":"Over 75","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"95"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"95"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"44"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"51"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"95"}]}],"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"2"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"93"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"95"}]}],"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"40"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"54"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Race and Ethnicity Not Collected","populationDescription":"Race and Ethnicity were not collected from any participant.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}],"categories":[{"measurements":[{"groupId":"BG004","value":"0"}]}]}]},{"title":"Montgomery Asberg Depression Rating Scale (MADRS)","description":"This depression rating scale will be used to determine clinical outcome for depressed participants.\n\nScores range from 0-60. The higher the score, the worse the outcome (see below)\n\nNormal: 0-6 Mild Depression: 7-19 Moderate Depression: 20-34 Severe Depression: 35+ Very Severe Depression: 60","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Total score (sum of points)","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"95"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"1.27","spread":"1.64"},{"groupId":"BG001","value":"25.53","spread":"5.41"},{"groupId":"BG002","value":"27.08","spread":"5.56"},{"groupId":"BG003","value":"26.21","spread":"4.79"},{"groupId":"BG004","value":"20.02","spread":"1.84"}]}]}]},{"title":"IL-6 Levels","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"pg/mL","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"95"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4.89","spread":"3.75"},{"groupId":"BG001","value":"13.9","spread":"10.53"},{"groupId":"BG002","value":"4.12","spread":"4.05"},{"groupId":"BG003","value":"9.18","spread":"10.29"},{"groupId":"BG004","value":"8.02","spread":"4.57"}]}]}]},{"title":"IL-10 Levels","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"pg/mL","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"16"},{"groupId":"BG004","value":"95"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4.8","spread":"7.64"},{"groupId":"BG001","value":"43.53","spread":"67.4"},{"groupId":"BG002","value":"13.93","spread":"39.18"},{"groupId":"BG003","value":"17.9","spread":"27.49"},{"groupId":"BG004","value":"20.04","spread":"24.98"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"IL-6 Levels","description":"IL6 levels were measured in participants by blood draw 6 weeks after the first dose was given.","populationDescription":"Not everybody completed the final blood draw","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/mL","timeFrame":"up to week 6","groups":[{"id":"OG000","title":"Healthy Control","description":"Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study"},{"id":"OG001","title":"Placebo","description":"Participants meet DSM-IV criteria for MDD, and received placebo pills for the 6 week duration of the study"},{"id":"OG002","title":"Escitalopram","description":"Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study."},{"id":"OG003","title":"Escitalopram + Celecoxib","description":"Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"18"},{"groupId":"OG003","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.25","spread":"4.12"},{"groupId":"OG001","value":"18.24","spread":"15.63"},{"groupId":"OG002","value":"3.69","spread":"3.73"},{"groupId":"OG003","value":"6.84","spread":"4.83"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"IL6 levels in healthy controls pre- and post-treatment compared using a paired t-test","nonInferiorityType":"OTHER","pValue":".44","statisticalMethod":"t-test, 2 sided"},{"groupIds":["OG001"],"groupDescription":"IL6 levels in the placebo group pre- and post-treatment compared using a paired t-test","nonInferiorityType":"OTHER","pValue":".11","statisticalMethod":"t-test, 2 sided"},{"groupIds":["OG002"],"groupDescription":"IL6 levels in the escitalopram group pre- and post-treatment compared using a paired t-test","nonInferiorityType":"OTHER","pValue":".42","statisticalMethod":"t-test, 2 sided"},{"groupIds":["OG003"],"groupDescription":"IL-6 levels in the escitalopram + celecoxib group pre- and post-treatment compared using a paired t-tes","nonInferiorityType":"OTHER","pValue":".49","statisticalMethod":"t-test, 2 sided"},{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"IL6 levels at completion of study compared between all MDD groups (placebo, escitalopram, and escitalopram + celecoxib) and the healthy control group","nonInferiorityType":"OTHER","pValue":".23","statisticalMethod":"t-test, 2 sided"}]},{"type":"PRIMARY","title":"Montgomery Asberg Depression Rating Scale (MADRS)","description":"This depression rating scale will be used to determine clinical outcome for depressed participants.\n\nScores range from 0-60. The higher the score, the worse the outcome (see below)\n\nNormal: 0-6 Mild Depression: 7-19 Moderate Depression: 20-34 Severe Depression: 35+ Very Severe Depression: 60","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Total Score (Sum of Points)","timeFrame":"Week 6","groups":[{"id":"OG000","title":"Healthy Control","description":"Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study"},{"id":"OG001","title":"Placebo","description":"Participants meet DSM-IV criteria for MDD, and received placebo pills for the 6 week duration of the study"},{"id":"OG002","title":"Escitalopram","description":"Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study."},{"id":"OG003","title":"Escitalopram + Celecoxib","description":"Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"23"},{"groupId":"OG003","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.27","spread":"1.64"},{"groupId":"OG001","value":"19.14","spread":"7.92"},{"groupId":"OG002","value":"14.04","spread":"9.13"},{"groupId":"OG003","value":"12.93","spread":"9.59"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"MADRS scores at the final visit compared between the healthy control and escitalopram + celecoxib groups","nonInferiorityType":"SUPERIORITY","pValue":".003","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupIds":["OG000","OG002"],"groupDescription":"MADRS scores at the final visit compared between the healthy control and escitalopram groups","nonInferiorityType":"SUPERIORITY","pValue":"<.001","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupIds":["OG000","OG001"],"groupDescription":"MADRS scores at the final visit compared between the healthy control and placebo groups","nonInferiorityType":"SUPERIORITY","pValue":".034","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupIds":["OG001","OG002","OG003"],"groupDescription":"MADRS scores at the final visit compared between the placebo groups and all groups receiving escitalopram (both with and without celecoxib)","nonInferiorityType":"SUPERIORITY","pValue":".03","statisticalMethod":"ANCOVA"}]},{"type":"PRIMARY","title":"IL10 Levels","description":"IL10 levels were measured in participants by blood draw 6 weeks after the first dose was given","populationDescription":"Not everybody completed the last blood draw","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/mL","timeFrame":"up to 6 weeks","groups":[{"id":"OG000","title":"Healthy Control","description":"Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study"},{"id":"OG001","title":"Placebo","description":"Participants meet DSM-IV criteria for MDD, and received placebo pills for the 6 week duration of the study"},{"id":"OG002","title":"Escitalopram","description":"Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study."},{"id":"OG003","title":"Escitalopram + Celecoxib","description":"Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"18"},{"groupId":"OG003","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.21","spread":"5.83"},{"groupId":"OG001","value":"64.9","spread":"82.16"},{"groupId":"OG002","value":"12.24","spread":"29.32"},{"groupId":"OG003","value":"18.56","spread":"28.9"}]}]}],"analyses":[{"groupIds":["OG000"],"groupDescription":"IL10 levels in healthy controls pre- and post-treatment compared using a paired t-test","nonInferiorityType":"OTHER","pValue":".29","statisticalMethod":"t-test, 2 sided"},{"groupIds":["OG001"],"groupDescription":"IL10 levels in the placebo group pre- and post-treatment compared using a paired t-test","nonInferiorityType":"OTHER","pValue":".19","statisticalMethod":"t-test, 2 sided"},{"groupIds":["OG002"],"groupDescription":"IL10 levels in the escitalopram group pre- and post-treatment compared using a paired t-test","nonInferiorityType":"OTHER","pValue":".5","statisticalMethod":"t-test, 2 sided"},{"groupIds":["OG003"],"groupDescription":"IL10 levels in the escitalopram + celecoxib group pre- and post-treatment compared using a paired t-test","nonInferiorityType":"OTHER","pValue":".55","statisticalMethod":"t-test, 2 sided"},{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"IL10 levels at completion of study compared between all MDD groups (placebo, escitalopram, and escitalopram + celecoxib) and the healthy control group","nonInferiorityType":"OTHER","pValue":".06","statisticalMethod":"t-test, 2 sided"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Baseline to 6 weeks","eventGroups":[{"id":"EG000","title":"Healthy Control","description":"Participants do not meet DSM-IV criteria for MDD, and did not receive any medication throughout the study","deathsNumAffected":0,"deathsNumAtRisk":30,"seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":0,"otherNumAtRisk":30},{"id":"EG001","title":"Placebo","description":"Participants meet DSM-IV criteria for MDD, and receieved placebo pills daily for the 6 week duration of the study\n\nEscitalopram + Placebo: Participants will receive a placebo in addition to escitalopram.","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":1,"otherNumAtRisk":20},{"id":"EG002","title":"Escitalopram","description":"Participants meet DSM-IV criteria for MDD and received a dose of escitalopram between 10-20mg, or a 10-20mg dose of escitalopram as well as a placebo pill daily for the 6 week duration of the study.","deathsNumAffected":0,"deathsNumAtRisk":29,"seriousNumAffected":2,"seriousNumAtRisk":29,"otherNumAffected":7,"otherNumAtRisk":29},{"id":"EG003","title":"Escitalopram + Celecoxib","description":"Participants meet DSM-IV criteria for MDD and received a 10-20mg dose of escitalopram and a 400mg dose of celecoxib daily for the 6 week duration of the study","deathsNumAffected":0,"deathsNumAtRisk":16,"seriousNumAffected":2,"seriousNumAtRisk":16,"otherNumAffected":9,"otherNumAtRisk":16}],"seriousEvents":[{"term":"Elevated Blood Pressure","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":16}]},{"term":"Dizziness","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Confusion","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Bradycardia","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Thoughts of Suicide in Response to Cognitive Task Item","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Suicidal Ideation","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":16}]}],"otherEvents":[{"term":"Vasovagal Response","organSystem":"Vascular disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":16}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":5,"numAffected":4,"numAtRisk":29},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":16}]},{"term":"Dizziness/Light Headed","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Jittery","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Urinating Frequently","organSystem":"Renal and urinary disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Yawning Frequently","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Claustophobia","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":16}]},{"term":"Loss of Libido","organSystem":"Reproductive system and breast disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG003","numEvents":2,"numAffected":1,"numAtRisk":16}]},{"term":"Skin Rash","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":16}]},{"term":"Grinding Teeth","organSystem":"Ear and labyrinth disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":16}]},{"term":"More Tired/Lethargy","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Dry Mouth","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Withdraw Symptoms from Discontinuing Escitalopram Improperly","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":16}]},{"term":"Elevated Blood Pressure","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":16}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Slipped on Escalator When Leaving Visit","organSystem":"Injury, poisoning and procedural complications","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Sore Chest","organSystem":"Surgical and medical procedures","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Sore Lower Back","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":3,"numAffected":2,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Change in Sleep Pattern","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":20},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]},{"term":"Sexual Side Effect Delayed Ejaculation","organSystem":"Reproductive system and breast disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":30},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":20},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":16}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Yvette Sheline, McLure Professor of Radiology, Neurology and Psychiatry","organization":"University of Pennsylvania","email":"sheline@pennmedicine.upenn.edu","phone":"(215) 573-0082"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2019-08-19","uploadDate":"2023-08-14T10:11","filename":"Prot_SAP_000.pdf","size":3156241},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2020-06-04","uploadDate":"2023-07-18T17:00","filename":"ICF_001.pdf","size":1467296}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003863","term":"Depression"},{"id":"D007249","term":"Inflammation"}],"ancestors":[{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"},{"id":"D010335","term":"Pathologic Processes"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D000089983","term":"Escitalopram"},{"id":"D000068579","term":"Celecoxib"}],"ancestors":[{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009570","term":"Nitriles"},{"id":"D001572","term":"Benzofurans"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D000096926","term":"Benzenesulfonamides"},{"id":"D013449","term":"Sulfonamides"},{"id":"D000577","term":"Amides"},{"id":"D001555","term":"Benzene Derivatives"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D013450","term":"Sulfones"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D011720","term":"Pyrazoles"},{"id":"D001393","term":"Azoles"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"}]}},"hasResults":true}