[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100381373":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":46,"responsibleParty":66,"collaborators":40,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":40,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":49,"whyStopped":40,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Cincinnati","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Escitalopram","ACTIVE_COMPARATOR","Adaptively randomized, double-blind treatment with escitalopram for 11 weeks in Phase 1. Non-remitting patients will be randomized in Phase 2 to adjunctive clonazepam or pregabalin for 8 weeks. Additionally, adults who are already treated with escitalopram or citalopram for at least 6 weeks prior to screening, may enter Phase 2 and be randomized to adjunctive clonazepam or pregabalin for 8 weeks.",[13],"Drug: Escitalopram",{"label":15,"type":10,"description":16,"interventionNames":17},"Duloxetine","Adaptively randomized, double-blind treatment with duloxetine for 11 weeks in Phase 1. Non-remitting patients will be randomized in Phase 2 to adjunctive clonazepam or pregabalin for 8 weeks. Additionally, adults who are already treated with duloxetine for at least 6 weeks prior to screening, may enter Phase 2 and be randomized to adjunctive clonazepam or pregabalin for 8 weeks.",[18],"Drug: Duloxetine",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Escitalopram, a SSRI, commercially known as LexaproTM, is commonly prescribed for anxiety disorders and is FDA-approved for acute and maintenance treatment of MDD and GAD.",[9],[25],"Lexapro",{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Duloxetine, a SNRI, commercially known as CymbaltaTM, is FDA-approved for the treatment of GAD, MDD, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain in adults.",[15],[30],"Cymbalta",[32],{"name":33,"affiliation":5,"role":34},"Jeffrey R Strawn, MD, FAACAP","PRINCIPAL_INVESTIGATOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Heidi K Schroeder, BS","CONTACT","(513) 558-4422",null,"heysehk@uc.edu",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Zoe N Neptune, BS","(513) 558-2866","neptunza@uc.edu",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience","RECRUITING","Cincinnati","Ohio","45219","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-84.51439,39.12711,{"lat":59,"lon":58},[62,65],{"name":33,"role":38,"phone":63,"phoneExt":40,"email":64},"513-558-4315","strawnjr@ucmail.uc.edu",{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},{"type":34,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Jeffrey Strawn, MD","Associate Professor of Psychiatry & Pediatrics, Director, Anxiety Disorders Research Program","100381373","phase-4-determining-optimal-treatment-sequences-in-anxious-depression-dots-ad-100381373",false,"NCT04245748","Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)","DOTS-AD","Inclusion Criteria:\n\n* Written, informed consent.\n* Patients must be fluent in the English.\n* 18 to 50 years of age, inclusive, at Visit 1.\n* Patients must meet DSM-5 criteria for generalized, social and\u002For separation anxiety disorder and\u002For panic disorder, confirmed by the MINI.99 Patients may also meet criteria for persistent depressive disorder or major depressive disorder however, these may not be the primary focus of treatment.\n* HAM-A score ≥20 at Visits 1 and 2.\n* Clinical Global Impressions- Severity (CGI-S) score ≥4 at Visits 1 and 2.\n* No clinically significant abnormalities on physical examination and EKG.\n* Negative pregnancy test at Visit 1 in females.\n* Negative urine drug screen at Visit 1.\n* Sexually active patients must practice a reliable method of contraception (Section 15.0) that will continue for the duration of the study and for a minimum of 30 days following the end of study participation. Reliable methods of contraception are defined below; other forms of contraceptives (pharmacological and\u002For non-pharmacological) are not accepted:\n\n  1. Surgical sterilization\n  2. Oral contraceptives (e.g. estrogren-progestin combination or progestin)\n  3. Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)\n  4. Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II\u002FJadelle)\n  5. An intrauterine device\n  6. Diaphragm plus condom.\n* For patients directly enrolling into Phase 2: treatment with escitalopram (or its racemic equivalent citalopram) or duloxetine for ≥6 weeks, at time of screening.\n\nExclusion Criteria:\n\n* DSM-5 diagnosis other than generalized anxiety, social anxiety, separation anxiety or panic disorder(s) that is the primary focus of treatment.\n* A history of intellectual disability.\n* Suicide risk as determined by either: (1) any suicide attempt within the past 6 months and\u002For (2) significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator.\n* Allergy, intolerance, non-response or hypersensitivity to escitalopram, duloxetine, pregabalin or clonazepam.\n* Subjects taking other medications that require a taper or washout of more than 5 days.\n* Patients who have initiated\u002Fterminated psychotherapy\u002Fbehavior therapy within 1 month before Visit 2 (Baseline) will be excluded; if the patient is engaged in psychotherapy, it must have been stable for 1 month prior to baseline.\n* A clinically-significant medical illness.\n* QTc \\>450 in males or \\>460 in females (prolonged QTc based on American Heart Association recommendations for Standardization and Interpretation of the EKG100\n* Alcohol or substance use disorder within 6 months of baseline (nicotine use is permitted).\n* Positive urine pregnancy test\u002Fpregnancy or breast feeding.\n* A positive urine drug screen.\n* Patients who are unable to swallow capsules.","ALL","18 Years","50 Years",{"count":80,"type":81},84,"ESTIMATED","INTERVENTIONAL",[84],"PHASE4","Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by double-blind, randomized adjunctive treatment with clonazepam or pregabalin for persistent symptoms.",[87,88],"Anxious Depression","Depression",[87],"2024-08-28",{"date":92,"type":93},"2024-08-29","ACTUAL",{"date":95,"type":93},"2020-03-01",{"date":97,"type":81},"2025-12-31",{"name":5,"class":6},1]