[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-schizophrenia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-schizophrenia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100621344","deep-brain-stimulation-of-the-nucleus-accumbens-and-anterior-limb-of-the-internal-capsule-in-the-treatment-of-refractory-schizophrenia-100621344",false,"NCT07369401","Deep Brain Stimulation of the Nucleus Accumbens and Anterior Limb of the Internal Capsule in the Treatment of Refractory Schizophrenia","Efficacy and Safety of Deep Brain Stimulation of the Nucleus Accumbens and Anterior Limb of the Internal Capsule in the Treatment of Refractory Schizophrenia: A Prospective, Single-Center, Double-Blind, Randomized Controlled Study","Inclusion Criteria:\n\n* Aged 18-55 years (inclusive) at the time of signing the informed consent form, male or non-pregnant female;\n* Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for schizophrenia;\n* Schizophrenia disease course ≥ 5 years before screening;\n* Meets the 2016 TRRIP criteria for refractory\u002Fultra-refractory schizophrenia: previous treatment with ≥ 2 non-clozapine antipsychotics at adequate dose (≥ 600mg\u002Fday chlorpromazine equivalent) and duration (≥ 12 weeks) with no response or intolerance, or clozapine at adequate dose (≥ 300mg\u002Fday or plasma concentration ≥ 350ng\u002Fml) and duration (≥ 12 weeks) with no response or intolerance, plus moderate or greater symptom severity;\n* PANSS total score ≥ 70 at screening and baseline;\n* No changes in medication regimen in the past 2 months;\n* The patient and their guardian have been fully informed and signed the informed consent form.\n\nExclusion Criteria:\n\n* Comorbid with epilepsy, severe cognitive impairment (Mini-Mental State Examination \\[MMSE\\] score \\\u003C 10), organic mental disorder, paranoid personality disorder, mental retardation, or addiction (other than nicotine);\n* Has implanted devices such as cochlear implants or cardiac pacemakers, or has undergone surgery that may affect the trial within 6 months;\n* Has contraindications to DBS implantation and is deemed unsuitable for surgery by the investigator;\n* Has participated in other drug\u002Fmedical device clinical trials within 3 months before screening;\n* Confirmed HIV-positive;\n* Pregnant\u002Flactating women, women of childbearing age with positive HCG\u002Furine pregnancy test at screening, those unable to use effective contraception during the trial, or those planning to conceive within 3 months after trial initiation;\n* Other conditions deemed unsuitable for participation by the investigator.","ALL","18 Years","55 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","Schizophrenia is a lifelong psychiatric disorder with a prevalence rate of 0.559% and a lifetime prevalence rate of 0.588% among Chinese adults. It often causes social dysfunction and psychiatric disability, shortening patients' life expectancy by 10-25 years compared to the general population. Approximately 30% of patients are resistant to antipsychotic medications, and 60% of these do not respond to clozapine (ultra-refractory). DBS has shown definite efficacy in movement disorders and refractory obsessive-compulsive disorder (OCD) as well as major depressive disorder (MDD). Preliminary studies have indicated that DBS targeting sites such as the NAcc can improve symptoms in some schizophrenia patients. Additionally, abnormal white matter in the anterior limb of the internal capsule has been identified in refractory patients, providing a basis for exploring combined target stimulation.\n\nThis study aims to investigate the efficacy and safety of deep brain stimulation of the Nucleus Accumbens and Anterior Limb of the Internal Capsule in the treatment of refractory schizophrenia. A randomized controlled (self-controlled) design is adopted. The statistical analysis unit generates a random allocation table using SAS software, and groups are assigned via central randomization. Both groups undergo three stimulation phases: DBS activation 2 weeks after surgery, 6 weeks of single-target stimulation followed by 2 weeks of shutdown, another 6 weeks of alternate single-target stimulation followed by 2 weeks of shutdown, and finally 6 weeks of combined dual-target stimulation. Trial Group 1 is stimulated sequentially at NAcc, Anterior Limb of the Internal Capsule, and dual targets; Trial Group 2 follows the reverse order for single-target stimulation before combined stimulation. Surgery is performed under general anesthesia by neurosurgeons with associate senior titles or above and extensive experience. After head frame placement, CT and MRI images are fused for targeting. Electrodes are implanted into the NAcc via the Anterior Limb of the Internal Capsule, and a pulse generator is placed under the clavicle and connected to the electrodes. Postoperative CT confirms electrode position. Trial devices are provided by Jingyu Medical Technology (Suzhou) Co., Ltd., including implantable neurostimulation systems, electrode leads, extension leads, and programming equipment. On-site follow-up is conducted at key time points: screening, baseline, 2 weeks postoperatively (DBS activation), 6 weeks after stimulation, 16 weeks postoperatively, and 24 weeks postoperatively, including scale assessments, physical examinations, and laboratory\u002Fimaging tests. The primary outcome measure was the reduction rate of the total PANSS score at 24 weeks after DBS implantation compared to baseline, with a 20% reduction defined as effective, assessed by independent psychiatric evaluators.",[27],"Refractory Schizophrenia",[29,27,30,31],"Deep Brain Stimulation","Nucleus Accumbens","Anterior Limb","NOT_YET_RECRUITING","2026-01-18",{"date":35,"type":36},"2026-01-27","ACTUAL",{"date":38,"type":21},"2026-01-20",{"date":40,"type":21},"2026-12-31",{"name":42,"class":43},"First Affiliated Hospital of Fujian Medical University","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":65,"locationsCount":68},"100293021","phase-2-an-adaptive-phase-iiiii-two-part-double-blind-randomized-placebo-controlled-dose-finding-multi-center-study-of-the-safety-and-efficacy-of-naben-as-an-add-on-therapy-with-clozapine-for-residual-symptoms-of-refractory-schizophrenia-in-adults-100293021","NCT03094429","An Adaptive Phase II\u002FIII, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults","An Adaptive Phase II\u002FIII, Double-Blind, Randomized, Placebo-controlled, Two-Part, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®,a D-Amino Acid Oxidase Inhibitor, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults","Inclusion Criteria:\n\n1. Male or female subjects who are between 18 and 55 years of age inclusive\n2. Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements, or the subject has a Legally Authorized Representative (LAR) who can provide consent to be enrolled into the study\n3. If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an Intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) \"double-barrier\" contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU\u002FmL and an estradiol level less than 30 pg\u002FmL\n4. The subject has Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject's recorded history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview For Schizophrenia and Psychotic Disorders, version 7.0 (MINI, Version 7.0)\n5. The subjects should have refractory schizophrenia as defined below (should meet at least two: either a and b; or a and c; or a and b and c):\n\n   1. Prior non-response to at least 2 antipsychotic drugs of two different chemical classes for at least 4-6 weeks each at doses ≥ 400 mg equivalents of chlorpromazine or 4 mg\u002Fday risperidone, AND\n   2. No period of good functioning in previous 2 years; OR,\n   3. Moderate to severe psychopathology (total PANSS score equal or more than 70): including persistent psychotic symptoms, recurrent mood symptoms, repeated suicide attempts or suicidal ideation, uncontrolled aggressive behavior, moderate to severe positive or negative symptoms or moderate-severe cognitive impairment\n6. The subject has been receiving clozapine for a minimum of 6 months with the dose range of 200-900 mg\u002Fday. The dose should have remained unchanged for at least 3 months prior to Screening and not expected to change during the study\n7. The subject is outpatient, and has been consistently symptomatic without significant fluctuation per the Investigator, with no hospitalization for worsening of schizophrenia within 3 months of the Screening. If the subject is hospitalized during the study for worsening of schizophrenia symptoms the subject will be withdrawn from the study\n8. The subject has a minimum PANSS total score of 70 at the Screening and Baseline Visits (Visits 1 and 2)\n9. Without clinically significant abnormalities in physical exam, neurological exam and laboratory assessments (urine\u002Fblood routine, biochemical tests and ECG) which would exclude the subject from the study in the opinion of the Investigator. For ALT and AST, clinically significant is defined as above two and a half times the upper limit of normal\n10. Body Mass Index (BMI) between 17 and 38 inclusive\n11. Subject has a negative routine urine illicit drug screening test (including heroin, amphetamines (including MDMA\u002Fecstasy), cocaine, cannabis or PCP)\n12. The subject has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) as determined by the Investigator and per the local regulations. The identified caregiver should be considered reliable by the Investigator and per the local regulations in providing support to the subject to help ensure compliance with study treatment, study visits and protocol procedures who preferably is also able to provide input helpful for completing study rating scales\n13. The subject must not be a danger to themselves or others per the Investigator's judgment\n\nExclusion Criteria:\n\n1. Meets the DSM-V criteria at Screening for intellectual disability, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia, or any other comorbid mental disorders that in the opinion of the Investigator may interfere with study conduct and results interpretation\n2. Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to Screening\n3. Initiation or dose change of benzodiazepines or sleep medications, or any other psychotropic medications due to worsening of schizophrenia symptoms or medication side effects within four (4) weeks prior to Screening\n4. The subject has previously received NaBen®\n5. History of epilepsy, major head trauma, or any neurological illness other than Tourette's syndrome which might impair the subject's cognition or psychiatric functioning per the Investigator's judgment\n6. History of allergic reaction to sodium benzoate\n7. Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator, may interfere with the conduct of the study\n8. Any significant gastrointestinal disorders that, in the opinion of the Investigator, markedly alter the absorption, metabolism or elimination of sodium benzoate\n9. Any movement disorders with a total score higher than 6 on SAS scale, or more than 2 on any items of the AIMS scale\n10. Current substance abuse, or history of meeting criteria for moderate or severe substance abuse (including alcohol, but excluding nicotine and caffeine) in the past six (6) months prior to Screening\n11. Female subjects who are pregnant (as confirmed by serum pregnancy test performed at Screening Visit) or are breast feeding\n12. History of cancer not in remission for the last three (3) years except for basal cell carcinoma and squamous cell carcinoma\n13. Participation in a clinical trial within 3 months prior to Screening or more than two clinical trials within 12 months\n14. Electroconvulsive Therapy (ECT) within 6 months prior to Screening\n15. The subject started a new non-medication treatment for schizophrenia or other psychiatric condition within the last 3 months prior to Screening (e.g. individual psychotherapy, cognitive behavioral therapy or rehabilitative therapy)\n16. The subject's anti-EPS medications dose or regimen has changed within 2 weeks prior to Screening\n17. The subject's PANSS total score has decreased more than 20 percent using PANSS score evaluations at Visit 1 and Visit 2",{"count":52,"type":21},287,[54,55],"PHASE2","PHASE3","This is an adaptive, Phase II\u002FIII study in 2 parts (i.e. Part 1 (dose ranging) and Part 2 (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as treatment for refractory schizophrenia.\n\nPart 1 Objectives: There are two primary objectives for Part 1 of this study:\n\n1. To evaluate, in terms of dose-response, the effectiveness of NaBen® (1000 and 2000 mg\u002Fday) compared to Placebo (0 mg\u002Fday), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults, and; to determine the optimal dose to be used in Part 2 of this study.\n2. Sample size re-assessment to evaluate the final sample size needed to proceed with Part 2 of the study The secondary objective of the Part 1 of this study is to evaluate the safety and tolerability of NaBen® (1000 and 2000 mg\u002Fday) compared to Placebo (0 mg\u002Fday), in combination with clozapine.\n\nPart 2 Objectives: The primary objective of the Part 2 of this study is to evaluate the effectiveness of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg\u002Fday), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults. The secondary objective of the Part 2 of this study is to evaluate the safety and tolerability of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg\u002Fday), in combination with clozapine.",[27],"RECRUITING","2021-09-10",{"date":61,"type":36},"2021-09-13",{"date":63,"type":36},"2017-03-29",{"date":40,"type":21},{"name":66,"class":67},"SyneuRx International (Taiwan) Corp","INDUSTRY",1]