[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"treatment-resistant-schizophrenia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:treatment-resistant-schizophrenia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,48,82,109,133,162,193,217,246],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100607135","phase-3-evenamide-a-glutamate-release-modulator-as-add-on-to-standard-of-care-in-subjects-with-documented-treatment-resistant-schizophrenia-100607135",false,"NCT07184619","Evenamide, a Glutamate Release Modulator, as Add-On to Standard of Care in Subjects With Documented Treatment-Resistant Schizophrenia","A Phase III, 12-week, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Determine the Efficacy, Safety, and Tolerability of a Dose of 15 mg Bid of Evenamide as add-on in Patients With Documented Treatment-resistant Schizophrenia, Which is Not Adequately Controlled by a Stable Therapeutic Dose of the Patient's Current Antipsychotic Medication(s)","ENIGMA-TRS 2","Key Inclusion Criteria:\n\n* Age - 18 years, or older.\n* If female, the subject has a negative pregnancy test at the screening visit and at baseline, is not lactating, and agrees to use adequate contraception, unless not of childbearing potential.\n* Meets current DSM-5-TR criteria for schizophrenia.\n* Has shown treatment-resistance to antipsychotics as per TRRIP working group definition (Howes et al., 2017).\n* Currently receiving \"standard of care\" therapy of a minimal recommended therapeutic dose of one or more antipsychotic(s).\n* Has a Clinical Global Impression - Severity of disease (CGI-S) rating of \"mildly ill\" to \"among the most extremly ill\" at baseline.\n* Has a BPRS total score ≥ 45 at screening and baseline.\n* Has a PANSS total score ≥ 70 at baseline.\n* Has a Global Assessment of Functioning (GAF) scale total score ≤ 50.\n* Adherence to prescribed antipsychotic treatment.\n* Patient has provided written informed consent prior to participating in the study.\n\nKey Exclusion Criteria:\n\n* Current DSM-5-TR diagnosis of schizophreniform disorder, schizoaffective disorder, or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder\n* History (within three months of study entry) or current diagnosis of \"Substance Use Disorder\" as defined by the DSM-5-TR criteria.\n* Severity of current episode of psychosis requires that the patient be hospitalized to stabilize the severity of his\u002Fher psychotic symptoms. However, these patients may qualify for the study provided their antipsychotic dose has been stable for 6 weeks prior to screening.\n* History or current diagnosis of other psychiatric or behavioral disorders.\n* Known suicidal risk, or a suicide attempt within the past 2 years.\n* History of neuroleptic malignant syndrome or priapism.\n* Disease\u002Fmedical condition of any type that may impact the patient's safety or interfere with any of the study evaluations.\n* History or current diagnosis of epilepsy or seizure disorder, or occurrence of a seizure within the past year, or repeated drug-induced seizures.","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a prospective, 12-week, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of a dose of evenamide of 15 mg bid, compared to placebo, as add-on treatment in patients with documented treatment-resistant schizophrenia (TRS) who have prospectively demonstrated inadequate response to their current stable therapeutic dose of an antipsychotic(s). Approximately 400 patients will be randomized equally (1:1) to each of the two treatment groups in this study.",[27],"Treatment-resistant Schizophrenia",[29,30,31,32,33,34],"evenamide","treatment-resistant schizophrenia","antipsychotic","schizophrenia","TRS","add-on treatment","RECRUITING","2026-06-03",{"date":38,"type":39},"2026-06-04","ACTUAL",{"date":41,"type":39},"2026-01-23",{"date":43,"type":21},"2026-12-31",{"name":45,"class":46},"Newron Pharmaceuticals SPA","INDUSTRY",10,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100624029","effectiveness-of-exercise-alone-and-tdcsexercise-on-cognitive-function-improvement-in-patients-with-treatment-resistant-schizophrenia-100624029","NCT07404319","Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant Schizophrenia","Randomised Control Trial of Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant Schizophrenia","TRACE","Inclusion Criteria:\n\n* DSM 5 schizophrenia-spectrum disorders\n* Treatment resistant schizophrenia: inadequate response to ≥2 antipsychotics of adequate dose\u002Fduration\n* Clinically stable ≥4 weeks\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Neurological disorder (e.g., epilepsy, stroke) or significant head injury\n* Implanted electronic devices \u002F contraindications to tDCS; scalp lesions at electrode sites\n* Medical contraindications to moderate aerobic exercise\n* Substance dependence within 3 months (except nicotine)\n* Pregnancy","60 Years",{"count":58,"type":21},160,[60],"NA","Cognitive impairment is a major determinant of disability in schizophrenia. Aerobic exercise improves global cognition in schizophrenia, particularly working memory and attention\u002Fvigilance. Transcranial direct current stimulation (tDCS) targeting frontal regions has shown promise for cognitive deficits, including working memory improvements in some studies. This randomized 2×2 factorial trial will test the independent and combined effects of supervised aerobic exercise and prefrontal tDCS on cognition in treatment resistant schizophrenia, measured using the MATRICS Consensus Cognitive Battery (MCCB).",[63,64,65],"Schizophrenia","Treatment Resistant Schizophrenia","Cognitive Impairment",[67,68,69,30],"tDCS","aerobic exercise","cognitive function","NOT_YET_RECRUITING","2026-02-04",{"date":73,"type":39},"2026-02-11",{"date":75,"type":21},"2026-02-23",{"date":77,"type":21},"2028-01-30",{"name":79,"class":80},"Kit Wa Chan","OTHER",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100567776","magnetic-seizure-therapy-for-schizophrenia---trial-100567776","NCT06672588","Magnetic Seizure Therapy for Schizophrenia - Trial","MAST","Inclusion Criteria:\n\n1. are inpatients or outpatients;\n2. demonstrate capacity to consent according to the MacArthur competence assessment tool for clinical research (MacCAT-CR);\n3. have a DSM-5 diagnosis of Schizophrenia or Schizoaffective Disorder for at least 2 years, as determined by the MINI International Neuropsychiatric Interview - Version 7 (MINI-7.0);\n4. are 18 years of age or older;\n5. have demonstrated resistance to at least 2 antipsychotics of 600 mg of chlorpromazine equivalents for at least 6 weeks;\n6. have a BPRS score at baseline of at least moderate severity (\\>4) on one of the four psychotic items (i.e., hallucinatory behavior, suspiciousness, conceptual disorganization, unusual thought content) or at least 12 on these 4 items combined;\n7. are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist;\n8. are on an antipsychotic at an adequate dose and are agreeable to keeping their current antipsychotic treatment constant during the acute phase of the intervention;\n9. are able to adhere to the intervention schedule;\n10. meet the MST safety criteria;\n11. If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.\n\nExclusion Criteria:\n\n1. have a history of MINI diagnosis of a substance use disorder (other than nicotine and caffeine) within the past three months;\n2. have a concomitant major unstable medical illness;\n3. are pregnant or intend to get pregnant during the study;\n4. have probable dementia based on study investigator assessment;\n5. have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;\n6. present with a serious medical condition,\n7. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n8. require a benzodiazepine with a dose \\> lorazepam 2 mg\u002Fday or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;\n9. are unable to communicate in English fluently enough to complete the neuropsychological tests;\n10. have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).",{"count":90,"type":21},80,[60],"This trial aims to assess the clinical effects and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Treatment Resistant Schizophrenia (RS).",[64,63,94],"Schizoaffective Disorder",[63,94,64,96,97,98],"Electroconvulsive Therapy","Magnetic Seizure Therapy","Convulsive Therapy","2026-01-30",{"date":101,"type":39},"2026-02-03",{"date":103,"type":39},"2025-04-22",{"date":105,"type":21},"2028-11",{"name":107,"class":80},"Centre for Addiction and Mental Health",2,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100551199","maintenance-electroconvulsive-therapy-in-clozapine-resistant-schizophrenia---the-mect-resist-trial-100551199","NCT06456983","Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial","MECT-RESIST","Inclusion Criteria:\n\n* Current schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), BPRS total score \\> 45 and history of clozapine resistant schizophrenia (CRS), which will include treatment-resistant schizophrenia with clozapine intolerance or absolute contraindications for clozapine;\n\nExclusion Criteria:\n\n1. Diagnosis of DSM-5 major neurocognitive disorder (\"dementia\"), current severe substance-use disorder, affective disorders with psychotic symptoms or any personality disorder;\n2. Inability to read\u002Fwrite German\n3. Pregnancy or breast-feeding;\n4. General medical condition contraindicating ECT.","75 Years",{"count":118,"type":21},140,[60],"Schizophrenia is one of the most severe and costliest mental disorders in terms of human suffering and societal expenditure. About 15-30% of patients do not respond to all known antipsychotics, including clozapine, the current gold-standard in these cases. Hence, a recent Cochrane review stated that the quality of the existing studies is too poor to recommend any intervention in addition to clozapine and that new, randomized controlled trials independent from the pharmaceutical industry need to be performed to substantially improve patient care. Although electroconvulsive therapy (ECT) was initially used to treat schizophrenia, it is nowadays by far underused in the therapy of schizophrenia in many countries. ECT is well known to be highly effective in clozapine-treatment-resistant schizophrenia (CRS), and synergistic effects of clozapine and ECT have been demonstrated. However, relapse rates after successful courses of ECT are still very high, and evidence for maintenance ECT (mECT) in CRS is scarce at best. In a multi-center trial the investigators aim to examine the effectiveness of mECT in treatment-resistant patients with schizophrenia who improved after a course of routine ECT. If mECT will lead to a later timepoint of relapse and\u002For to a higher proportion of relapse-free patients compared to those undergoing treatment as usual, this trial would have an enormous impact on therapeutic strategies for \"treatment-resistant\" patients and would induce a profound change of current treatment guidelines, where ECT still ranks at the level of ultima ratio, despite accumulating evidence suggesting otherwise.",[63,64],[123,124],"electroconvulsive therapy","ECT",{"date":101,"type":39},{"date":127,"type":39},"2025-02-14",{"date":129,"type":21},"2028-07",{"name":131,"class":80},"Central Institute of Mental Health, Mannheim",14,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":81},"100573681","cognitive-behavioral-therapy-for-sleep-and-circadian-disturbances-cbt-i-in-treatment-resistant-schizophrenia-100573681","NCT06749444","Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia","COSTS","Inclusion Criteria:\n\n* Diagnosed with ICD-10 schizophrenia (DF20), chronic paranoid psychosis (DF22), schizo-affective disorder (DF25) or other non-organic psychosis (DF28-DF29)\n* Treatment resistance according to TRRIP criteria\n* Sleeping difficulties (minimum duration 3 months)\n* ISI score \\>14\n* Stable psychopharmacological treatment the last month\n* Only legal competent patient can participant\n\nExclusion Criteria:\n\n* Psychiatric admission last six months (more than 1 week or resulted in significant changes in psychopharmacological treatment)\n* Substance abuse to a degree that will interfere with participation.\n* Diagnoses of sleep apnea\u002FCPAP use","64 Years",{"count":142,"type":21},60,[60],"Using a randomized controlled design, the project aims to test if cognitive behavioral therapy interventions specifically targeting sleep disorders can significantly lessen the burden of the disrupted sleep in patients with treatment resistant schizophrenia (TRS) and by proxy lead to a reduction in psychotic symptoms and improvement in quality of life.\n\nWe are including treatment-resistant patients with schizophrenia other nonorganic and chronic psychoses and in addition meeting the criteria of a sleep or circadian disorder. Included patients will be block randomized to either 8-10 sessions of CBT-I (active treatment) with a specific focus on sleep or 8-10 sessions of regularCBT with a specific focus on patients' psychopathology (treatment as usual) approx.1 session\u002Fweek.\n\nAfter 12 weeks the full battery of assessments will be repeated forboth groups. Primary analyses will be to identify group-difference in changes using repeated measure ANOVA.",[146,27],"Treatment-refractory Schizophrenia",[148,149,150,151,152],"Cognitive","CBT","Therapy","Insomnia","polysomnography","2026-01-16",{"date":155,"type":39},"2026-01-20",{"date":157,"type":39},"2024-11-28",{"date":159,"type":21},"2027-04-30",{"name":161,"class":80},"Jimmi Nielsen",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":81},"100462291","real-time-fmri-neurofeedback-in-patients-with-schizophrenia-and-auditory-hallucinations-100462291","NCT05299749","Real-time fMRI Neurofeedback in Patients With Schizophrenia and Auditory Hallucinations","Real-time fMRI Neurofeedback as a Tool to Mitigate Auditory Hallucinations in Patients With Schizophrenia - R33 Phase","Inclusion Criteria:\n\n* patients diagnosed with SZ or schizoaffective disorder using DSM-5 criteria\n* auditory hallucinations not responsive to pharmacology as determined by chart review and a clinical interview of SCID.\n\nExclusion Criteria:\n\n* neurologic illness\n* major head trauma\n* electroconvulsive therapy\n* alcohol or drug dependence\n* alcohol or drug abuse within the past five years\n* verbal IQ below 70","55 Years",{"count":171,"type":21},104,[60],"Neurofeedback intervention aimed to regulate the superior temporal gyrus (STG) activation and default mode network (DMN) connectivity as well as to reduce the auditory hallucinations (AH) schizophrenia patients with medication resistant AH.",[63,175,27],"Auditory Hallucination",[177,178,179,180,181,182,183],"Auditory-Hallucination","Connectivity","brain-activity","default-mode-network","superior temporal gyrus","Neurofeedback","MRI","2025-09-12",{"date":186,"type":39},"2025-09-18",{"date":188,"type":39},"2022-03-01",{"date":190,"type":21},"2026-06-30",{"name":192,"class":80},"Boston VA Research Institute, Inc.",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":81},"100543845","reduction-of-auditory-verbal-hallucinations-in-schizophrenia-through-cortical-neuromodulation-100543845","NCT06361160","Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation","Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation: Towards a Closed-loop System","HALLUSTIM","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Schizophrenic Disorder (Diagnostic and statistical manual of mental disorders, DSM-5-TR, American Psychiatric Association, 2013)\n* AVHs that have resisted to at least two properly conducted antipsychotic therapies at an effective dose for at least 8 weeks (criteria of Kinon et al., 1993)\n* Frequent AVHs (at least 10 times per hour) (Fovet et al., 2022)\n* Unmodified antipsychotic dosage for 30 days prior to inclusion in the protocol\n* AVH are the main residual symptom of schizophrenia.\n* Consent to participate in the study\n\nExclusion Criteria:\n\n* Pregnancy (based on date of last menstrual period with possibility of urine test if in doubt)\n* Anticonvulsant therapy\n* Neurological disorder (e.g., multiple sclerosis, epilepsy)\n* Current addictive behavior (except tobacco and cannabis, widely used in this clinical population; Fovet et al., 2022)\n* Contraindication to MRI (i.e., presence of ferromagnetic material or implanted neurostimulation devices due to the risk of displacement or dysfunction such as cochlear implants, cardiac pacemakers, metal splinters in the body following an accident, permanent makeup applied less than 6 months ago, neurosurgical clips, deep brain or vagus nerve stimulation devices, baclofen pumps) (Lefaucheur et al., 2011)\n* Morphological criteria: weight \\> 130 Kg, abdominal circumference conditioned by the opening of the magnet, shoulder width\n* Lack of coverage by the social security system\n* Current participation in another interventional research protocol or being in the exclusion period of a previous research protocol\n* Refusal to be informed of an brain anomaly detected in the MRI\n* Person under guardianship or curatorship\n* Behavioral disorders or delusions likely to prevent the MRI or rTMS from being performed under good conditions (left to the discretion of the investigator at baseline).",{"count":202,"type":21},20,[60],"Approximately 1% of the general population will be affected by schizophrenia over the course of their lives, with life expectancy being reduced by 20 years on average and quality of life being severely diminished in affected individuals. One third of patients suffering from schizophrenia will evolve towards a resistant form of the disease, amongst which many will suffer from auditory-verbal hallucinations (AVH) that current therapeutic approaches struggle to alleviate. Previous work from our team has demonstrated the possibility of robustly inferring the periods of occurrence of AVH from fMRI data, paving the way for the development of a closed-loop neuromodulation system comprised of an electrode array positioned in Broca's area, which would detect AVH in real time, and effector electrodes which would stimulate the temporo-parietal cortex to interrupt them. The aim of this project is to assess the feasibility of this system. To do so, we will first test the ability of transcranial magnetic stimulation of the \"continuous theta burst\" (cTBS) type, applied at the time of AVH onset, to reduce their duration and intensity, and assess whether this is associated with therapeutic response to the current gold standard rTMS protocol for AVH reduction through neuroplasticity induction. Demonstrating the feasibility of acute suppression of AVH by cortical neurostimulation is an essential element in the feasibility of a closed-loop reactive neuromodulation system.\n\nThe research project comprises two phases:\n\n-Phase 1: randomized controlled clinical trial (1 weekly session per patient over 12 weeks: 6 active stimulation sessions and 6 sham sessions) evaluating the phasic effects of rTMS on AVHs as they appear during the sessions.\n\nPhase 2: open-label study offering patients a routine rTMS protocol which has demonstrated its effects on AVH (10 TMS sessions over one workweek - twice daily with 1-hour intervals, MULTIMODHAL study, NCT01373866).",[64],[64,207],"Transcranial Magnetic Stimulation (TMS)","2024-07-26",{"date":210,"type":39},"2024-07-29",{"date":212,"type":39},"2024-05-21",{"date":214,"type":21},"2026-05",{"name":216,"class":80},"Centre Hospitalier St Anne",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":224,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":233,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":81},"100554944","effect-of-atenolol-versus-ivabradine-on-hrv-in-trs-patients-on-clozapine-with-tachycardia-a-randomised-control-trial-100554944","NCT06505668","Effect of Atenolol Versus Ivabradine on HRV in TRS Patients on Clozapine With Tachycardia: A Randomised Control Trial.","Effect Of Atenolol Versus Ivabradine On Heart Rate Variability In Treatment Resistant Schizophrenia Patients On Clozapine With Tachycardia: A Randomized Control Trial.","Inclusion Criteria:\n\nAll patients coming for treatment at the Out-patient department and In-patient department of the Department of Psychiatry fulfilling the following are included:\n\n1. Patients diagnosed with TRS (TRRIP consensus) receiving clozapine.\n2. Aged between 18 to 60 years of either sex\n3. Having baseline heart rate of \\>100\u002Fminute.\n4. Written informed consent from Legally Authorized representative.\n\nExclusion Criteria:\n\nPatients with any one of the following are excluded from the study:\n\n1. Already receiving Atenolol or Ivabradine.\n2. Patients having any contraindication to using Atenolol or Ivabradine.\n3. Receiving any other medication other than Clozapine known to cause autonomic dysregulation.\n4. Active substance use.\n5. Serious medical or neurological comorbidity.",true,{"count":226,"type":21},40,[60],"Clozapine is the only drug approved for Treatment Resistant Schizophrenia. However, it has been associated with many adverse drug reactions including agranulocytosis, myocarditis, sialorrhea, constipation, orthostasis, tachycardia. There are many factors that have impacted the use of clozapine in TRS patients including physician hesitation, patient denial, stopping of drug due to Adverse drug reactions.\n\nAlthough Tachycardia should not be the reason to stop clozapine, but data shows that it leads to discontinuation of drugs in significant patient population. If patient on clozapine develops tachycardia; first orthostasis, myocarditis and systemic infection should be ruled out. Tachycardia traditionally have been treated with B1 adrenergic blockers such as Atenolol. But the problem with beta blocker medications is that significant proportion develops hypotension.\n\nRecently developed Ivabradine slows heart rate via I(f) current, and is not associated with much cardiac adverse effects. Recent Clinical trials have been carried out to show its effects on Clozapine associated tachycardia which shows promising results. Some studies suggest using Ivabradine in patient population that have contraindication for beta blockers.\n\nAlthough both of these drugs are used widely in clinical practice, but as Ivabradine is relatively new drug there have been no head-to-head comparison with Atenolol. A recent meta-analysis tried to compare treatment efficacy in these patients, but found no studies that met their inclusion criteria. This current study attempts to make such comparison and guide further research.",[64,230,231,232],"Clozapine Adverse Reaction","Heart Rate Variability","Tachycardia",[234,235,236],"Clozapine","Treatment resistant schizophrenia","heart rate variability","2024-07-11",{"date":239,"type":39},"2024-07-17",{"date":241,"type":39},"2023-08-01",{"date":243,"type":21},"2025-06-30",{"name":245,"class":80},"All India Institute of Medical Sciences, Bhubaneswar",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":255,"phases":4,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":81},"100444999","dundrum-forensic-redevelopment-evaluation-study-d-forest-study-100444999","NCT05074732","Dundrum Forensic Redevelopment Evaluation Study: D-FOREST Study.","D-FOREST","Inclusion Criteria:\n\n* Admitted to the National Forensic Mental Health Service (NFMHS) Ireland after 1st December 2019 until 7 years after the transfer of the National Service to the newly developed complete National Forensic Service at Portrane, North Dublin, Ireland.\n\nExclusion Criteria:\n\n* This study comprises a complete cohort of admissions to the NFMHS. All adult patients admitted during the time period will be included in the study, regardless of their length of stay.",{"count":254,"type":21},350,"OBSERVATIONAL","The DUNDRUM Forensic Redevelopment Evaluation study (D-FOREST study) is a multi-site comprehensive evaluation of a complete National Forensic Mental Health Service. The study will have a prospective, observational, longitudinal design which will permit the evaluation of benefit over time for individual patients, groups of patients and the evaluation of the benefit in terms of service based outcomes of the redevelopment of a complete National Forensic Mental Health Service e.g. effects on waiting list times, length of stay. The study will systematically evaluate multiple domains of recovery in a complete National Forensic Service, including patients' physical health, mental health, offending behaviours and social and occupational functioning.",[63,258,259,260,261,262,263,264,265,266,267,27],"Forensic Psychiatry","Outcome Measure","Violence","Personality Disorders","Recovery","Obesity","Type II Diabetes","Cardiovascular Diseases","Frailty","Psychosis","2021-10-02",{"date":270,"type":39},"2021-10-12",{"date":272,"type":39},"2019-12-01",{"date":274,"type":21},"2027-12-31",{"name":276,"class":80},"Health Service Executive, Ireland"]