[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Corporal Michael J. Crescenz VA Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100638226","phase-4-pilot-deprescribing-of-antimuscarinic-overactive-bladder-medications-in-parkinson-disease-100638226",false,"NCT07627529","Pilot Deprescribing of Antimuscarinic Overactive Bladder Medications in Parkinson Disease","Evaluating the Effect of Deprescribing Antimuscarinic Overactive Bladder Medications on Cognitive Function and Quality of Life of Individuals With Parkinson Disease: A Pharmacist-led Series of N-of-1 Trials","Inclusion Criteria:\n\n1. 60+ years old at time of enrollment\n2. Have a diagnosis of Parkinson disease (PD) made by a movement disorders specialist\n3. Life expectancy of at least six months\n4. Are on an antimuscarinic for overactive bladder (OAB) symptoms (without concurrent use of a beta-3 agonist) for at least 3 months\n5. Are able to provide informed consent\n6. Are able to complete online surveys\u002Fquestionnaires\n7. Are able to receive telephone calls and Zoom calls\u002Ftelehealth meeting\n\nExclusion Criteria:\n\n1. Have untreated or uncontrolled hypertension (blood pressure \\[BP\\] ≥180\u002F110 mmHg),\n2. Have active urinary tract infection (UTI) or chronic\u002Frecurrent UTI (≥2 UTIs in six months or ≥3 in one year)\n3. Have moderate or severe hepatic impairment (Child-Pugh Score Class B or C)\n4. Have severe renal impairment (Estimated Glomerular Filtration Rate \\[eGFR\\] \\\u003C30 mL\u002Fmin\u002F1.72 m2) or end-stage renal disease (on dialysis or renal replacement therapy)\n5. Have prior history of hypersensitivity or intolerance to mirabegron or vibegron\n6. Have existing cognitive impairment (Montreal Cognitive Assessment \\[MoCA\\] score \\\u003C22\u002F30) or psychiatric disorder that preclude informed consent\n7. Have any other condition that, in Principal Investigator (PI) and Co-PI's opinion, makes the individual unsuitable for study participation\n8. On non-oral form of OAB antimuscarinics, the oral solution formulation of oxybutynin chloride or the oral suspension formulation of solifenacin succinate (due to complicated tapering process)","ALL","60 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This is an unblinded, non-randomized National Institute of Health (NIH) Stage I of Behavioral Intervention Development trial. The investigators will enroll 20 subjects with Parkinson disease (PD) for a series of 20 of N-of-1 trials. The investigators will use a single-arm crossover titration\u002Freversal design (\"ON\" \\[A\\] vs. \"OFF\" \\[B\\]) with up to 4 periods. All participants will follow the sequence ABAB. Each period will last up to 10 weeks, allowing for sufficient time for up-titration and onset of drug action, and down-titration and washout. Each participant will have the option to participate in less (2-3) or more (3-4) periods depending on whether additional information is needed to make an informed decision about continuing or discontinuing the overactive bladder (OAB) antimuscarinic at the end of the study. The intervention drug will be an OAB antimuscarinic, previously prescribed to the participants by their physician. The investigators will reduce the dose of each OAB antimuscarinic by 25-50% every 1-2 weeks during the \"OFF\" \\[B\\] period, with the goal to completely discontinue the medication.",[26],"Parkinson Disease (PD)",[28,29,30,31,32,33],"Parkinson disease","overactive bladder","antimuscarinic","deprescribing","cognitive function","quality of life","NOT_YET_RECRUITING","2026-05-31",{"date":37,"type":38},"2026-06-04","ACTUAL",{"date":40,"type":20},"2026-06",{"date":42,"type":20},"2027-04",{"name":44,"class":45},"Corporal Michael J. Crescenz VA Medical Center","FED",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":46},"100323751","phase-4-smoking-cessation-with-varenicline-in-schizophrenia-antipsychotic-induced-neurological-symptoms-as-correlates-100323751","NCT03495024","Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates","Effect of Varenicline on Smoking Cessation in Patients With Schizophrenia: Evaluation of Antipsychotic Drug-Induced Neurological Symptoms as Correlates of Response","Inclusion Criteria:\n\n* DSM 5 criteria for schizophrenia or schizoaffective disorder and stable disease\n* Glazer-Morgenstern-Doucette criteria for TD\n* Smoking at least 5 cigarettes on average daily for at least 30 days prior to screening\n* An exhaled carbon monoxide concentration greater than 5 parts per million (ppm) at screening\n* Agree to stop smoking by the target date (four weeks after baseline\n* Concurrence for varenicline treatment from the patient's mental health provider if the patient is under mental health care; OR, if the patient is not under mental health care, the prescribing clinician should consult with a mental health provider to evaluate the patient for appropriateness to receive varenicline\n\nExclusion Criteria:\n\n* Have untreated or unstable acute medical or psychiatric illnesses\n* Have a history of seizures\n* History of somnambulism\n* Have chronic degenerative neurological illnesses (e.g., Parkinson's disease)\n* Have a history of active substance abuse (including marijuana abuse) in the 3 months prior to screening or a positive toxicology screen\n* Are receiving clozapine or cholinesterase inhibitors\n* Had a change in dosing or medication type of antipsychotic or anti-muscarinic for one month prior to enrollment (two months for long-acting antipsychotics)\n* Are unable to remain on a stable dose of antipsychotic or anti-muscarinic during the study period\n* Have acute suicidal ideation, intent or behavior within 12 months or risk based assessed on the C-SSRS or depression\u002Fanxiety score ≥ 8 on the HADS.\n* Female subjects of childbearing age will have a negative pregnancy serum test at screening and are required to use approved methods of birth control\n* Use of an investigational drug within 30 days of screening\n* Use of other smoking cessation aids (bupropion, nicotine replacement products)\n* Use of other tobacco products\n* History of allergic reactions to varenicline\n* Lack capacity to provide informed consent","18 Years","75 Years",{"count":57,"type":20},10,[23],"To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.",[61,62,63,64,65],"Schizophrenia","Schizoaffective Disorder","Tobacco Smoking","Tardive Dyskinesia","Parkinsonism",[61,67,68,69,70,65],"Schizoaffective disorder","Antipsychotics","Tobacco smoking","Tardive dyskinesia","RECRUITING","2019-03-20",{"date":74,"type":38},"2019-03-22",{"date":76,"type":38},"2019-01-01",{"date":78,"type":20},"2020-06-30",{"name":44,"class":45},""]