[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizophrenia-psychosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizophrenia-psychosis":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,49,81,107,133,155,177,201],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100473460","investigating-the-neural-correlates-of-cognitive-function-in-psychosis-patients-and-non-psychiatric-controls-with-cannabis-use-100473460",false,"NCT05445180","Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use","Investigating the Neural Correlates of Cognitive Function Associated With Cannabis Abstinence in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use","Inclusion Criteria:\n\n* Able to provide informed consent in English or French\n* Heavy cannabis use (defined as weekly cannabis use for at six months) and\u002For DSM-5 diagnosis of CUD\n* Have a Full-Scale IQ ≥ 75\n* Meet DSM-5 criteria for a psychotic disorder (psychosis patient arm only)\n* Be an outpatient receiving a stable dose of medication(s) for at least two months (psychosis patient arm only)\n* Clinically stable (as measured by the PANSS-6, total score \\\u003C30) (psychosis patient arm only)\n\nExclusion Criteria:\n\n* current SUD (other than CUD)\n* MRI contraindications\n* Positive urine screen for psychoactive substances other than cannabis, nicotine, or caffeine\n* Current suicidal or homicidal ideation\n* Head injury requiring hospitalization or loss of consciousness \\> 5 minutes\n* Current medical diseases that requires hospitalization or regular monitoring\n* Being pregnant\n* DSM-5 Axis 1 diagnosis (other than CUD) (non-psychiatric controls only)\n* Taking psychotropic medication",true,"ALL","16 Years","80 Years",{"count":21,"type":22},134,"ESTIMATED","INTERVENTIONAL",[25],"NA","Cognitive impairment is well established in people with psychosis and is associated with cannabis use. The current study will investigate the neurobiological basis of cognitive change associated with 28-days of cannabis abstinence in people with psychosis and non-psychiatric controls with cannabis use. Participants will be randomized to a cannabis abstinent group or a non-abstinent control group and will undergo magnetic resonance imaging at baseline and following 28-days of abstinence. This study will help characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use and its recovery which may guide the development of novel interventions for problematic cannabis use.",[28,29,30,31,32,33,34,35],"Psychotic Disorders","Cannabis Use Disorder","Cannabis Dependence","Cannabis Use","Schizophrenia; Psychosis","Cognitive Dysfunction","Memory Impairment","Neuroimaging","RECRUITING","2026-05-19",{"date":39,"type":40},"2026-05-22","ACTUAL",{"date":42,"type":40},"2022-04-21",{"date":44,"type":22},"2027-05",{"name":46,"class":47},"Douglas Mental Health University Institute","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100599464","phase-3-a-study-evaluating-the-efficacy-of-xanomelinetrospium-xt-on-cognitive-impairment-after-24-and-52-weeks-of-treatment-in-adult-participants-with-schizophrenia-100599464","NCT07084831","A Study Evaluating the Efficacy of Xanomeline\u002FTrospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia","A Prospective, Open-label, Single-arm, Multicenter Study Evaluating the Efficacy of Xanomeline\u002FTrospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia","SHINE","Inclusion criteria:\n\n1. Be between 18 and 55 years of age.\n2. Be willing and able to provide informed consent, after the nature of the study has been fully explained. This includes being able to understand the locally approved informed consent (and information letter) in the local language.\n3. Have a current DSM-5 diagnosis of schizophrenia, which needs to be confirmed by MINI.\n4. Have all PANSS positive items + G8 and G10 ≤4 at screening.\n5. Be on a stable dose of oral antipsychotic medication(s) for at least 4 weeks prior to Screening. Participants should be on monotherapy oral AP for baseline visit.\n6. Have a SCIP total below 70.\n7. Test negative for pregnancy at the screening visit and must be using a highly effective contraceptive method during the study and 30 days after the study, if being a female of childbearing potential.\n\nExclusion criteria:\n\n1. Be pregnant, lactating, or less than 3 months postpartum.\n2. Be at significant risk of committing suicide. This is defined as: participants with active suicidal ideation with some intent to act, without specific plan (\"Yes\" to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS) or active suicidal ideation with specific plan and intent (\"Yes\" to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the participant to participate in the study.\n3. Currently meet DSM-5 criteria for a manic episode or major depressive disorder as confirmed by the MINI.\n4. Currently meeting DSM-5 criteria for severe substance and\u002For alcohol use disorder as confirmed by the MINI (≥6 on module K for alcohol use disorder and\u002For ≥6 on module J for substance use disorder, unless being in early or sustained remission).\n5. Have a positive urine toxicology for phencyclidine, amphetamines, opiates (unless participant has a valid prescription for short-term use), cocaine, or alcohol (clinically significant alcohol use in the opinion of the Investigator). Nicotine and caffeine use is allowed. Stimulants and cannabis is allowed when used sporadically and recreationally as per the judgement of the clinician.\n6. Present with an intellectual disability, drug-induced psychosis, or history of clinically significant brain trauma as per the judgement of the clinician.\n7. Have current or past use of clozapine (used for at least 6 weeks in an effective dose range) and\u002For current use of a long-acting injectable antipsychotic, or anticholinergic treatment that cannot be discontinued before the baseline visit.\n8. Be expected to require more than the allowed psychotropic concomitant medication during the study (from baseline on). This is defined as: needing benzodiazepines of more than 2 mg lorazepam equivalent (daily), quetiapine, antidepressants, mood stabilizers or benzodiazepines at a dose exceeding the allowed threshold. If these treatments are used at the screening visit, they must be tapered down before the baseline visit.\n9. Have clinically significant abnormal finding on the physical examination, medical history, ECG (at screening), or clinically significant laboratory results at screening.\n10. Participated in any cognitive remediation\u002Ftraining program or completed the BACS within 4 weeks of Screening.\n11. Having a known allergy to xanomeline, trospium chloride or any of the ingredients of XT.\n12. Have current presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (e.g., obstructive disorders \\[including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis\\], endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. This includes:\n\n12a. Have history or high risk of urinary retention. 12b. All grades of hepatic impairment (mild \\[Child-Pugh Class A\\], moderate \\[Child-Pugh Class B\\], and severe \\[Child-Pugh Class C\\]).\n\n12c. Elevations in hepatic transaminases at screening ≥ 2× ULN for ALT and AST and\u002For bilirubin \\> 2 × ULN, unless in the context of Gilbert's syndrome.\n\n12d. Have a history or high risk for narrow-angle glaucoma. 12e. Active biliary disease (e.g., symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the sponsor.\n\n12f. Participants with a history of bladder stones . 12g. Participants with a history of recurrent urinary tract infections. 12h. For all male participants, serum prostate-specific antigen \\>10 ng\u002FmL at screening.\n\n12i. For male participants ≥ 45 years of age, an IPSS score of 5 (i.e, \"almost always\") on items 1, 3, 5, or 6, and\u002For for male participants ≥ 45 years of age, an IPSS score ≥ 9 for the sum of items 1, 3, 5, and 6.\n\n12j. An eGFR of \\\u003C 60 mL\u002Fmin (which indicates renal dysfunction). 12k. History of unstable hypertension or tachycardia as evidenced by a blood pressure of ≥ 160\u002F100 mmHg at screening and\u002For a heart rate of ≥ 110 bpm at screening.","18 Years","55 Years",{"count":60,"type":22},171,[62],"PHASE3","Schizophrenia is a long-lasting and serious mental health disorder that affects about 1% of people worldwide. It can cause symptoms such as hallucinations and delusions (called positive symptoms), confused or disorganized thinking, reduced motivation and emotional expression (negative symptoms), difficulties with memory and concentration (cognitive symptoms), and movement problems like restlessness or slowed activity. Current treatments, called antipsychotics, mainly work by blocking dopamine in the brain. These medicines are helpful for hallucinations and delusions, but they do little to improve negative or cognitive symptoms.\n\nA new medicine, Xanomeline\u002FTrospium (XT), works differently. It targets a brain system called the muscarinic acetylcholine receptors while limiting side effects elsewhere in the body. Clinical trials have shown that XT reduces psychotic symptoms effectively and is generally well tolerated. The FDA approved XT in 2024 for adults with schizophrenia. Importantly, early results also suggest that XT may help improve thinking and memory (cognition domains), though this has not yet been studied in depth.\n\nMost schizophrenia drug studies pay little attention to long-term changes in cognition, often using only short screening tests. This study will be the first to take a deep look at cognitive function over a full year of XT treatment. It will also examine how changes in thinking skills connect with other aspects of life, such as symptom control, daily functioning, and quality of life. By making cognition a central outcome, the study responds to an urgent need in schizophrenia research: moving beyond just controlling hallucinations and delusions toward improving real-world recovery. The results could help shape future treatment strategies and support the idea that cognition should be a core treatment target in schizophrenia.",[32,65],"Cognitive Impairment",[67,68,69],"functioning","quality of life","speech analyses","NOT_YET_RECRUITING","2026-05-12",{"date":73,"type":40},"2026-05-13",{"date":75,"type":22},"2027-01-01",{"date":77,"type":22},"2029-07-01",{"name":79,"class":47},"European Group for Research In Schizophrenia",16,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100495455","outcomes-from-remediation-and-behavioural-intervention-techniques-100495455","NCT05731414","Outcomes From Remediation and Behavioural Intervention Techniques","Cognitive Behavioural Therapy Compared to Cognitive Remediation for Schizophrenia-Spectrum Disorders","ORBIT","Inclusion Criteria:\n\n* Aged 18-65 years\n* Diagnosed with schizophrenia-spectrum disorders\n* Can read, write, and speak English\n\nExclusion Criteria:\n\n* Neurodevelopmental disability or neurocognitive disorder\n* CBT or CR in the past 6 months","65 Years",{"count":91,"type":22},360,[25],"It is currently unknown what factors predict response to Cognitive Behavioural Therapy for Psychosis (CBTp) or Cognitive Remediation Therapy (CR) among individuals with schizophrenia-spectrum disorders, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy.",[95,96,28,32],"Schizophrenia","Psychosis","2025-08-13",{"date":99,"type":40},"2025-08-19",{"date":101,"type":40},"2023-03-01",{"date":103,"type":22},"2027-01-31",{"name":105,"class":47},"University of Toronto",2,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":89,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":48},"100481526","efficacy-of-maintenance-repetitive-transcranial-magnetic-stimulation-rtms-in-auditory-verbal-hallucinations-100481526","NCT05550155","Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) in Auditory Verbal Hallucinations","Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Reducing Auditory Verbal Hallucinations (AVH) With High Frequency and Neuronavigation Guidance: A Double-blind, Randomized and Multicentric Study","MAINSTIM","Inclusion Criteria:\n\n* Male or female; Age ≥ 18 years ≤ 65 years\n* Diagnosis of schizophrenia or schizoaffective disorders according to DSM 5.0 criteria\n* Patients treated with at least one antipsychotic medication\n* Presence of auditory verbal hallucinations despite the optimization of the antipsychotic dosage for at least 6 weeks. This will be operationalized by a minimum AHRS score \\> 10\n* Stable medication dosage for at least 6 weeks before the rTMS treatment\n* Patient who understands the French language\n* The agreement of the curatorship or tutorship in the case of a protected adult\n* Willing to comply with scheduled visits, as outlined in the protocol\n* Covered by, or having the right to Social Security or European cover\n* Informed and written consent\n\nExclusion Criteria:\n\n* Women who are pregnant\n* Patients with contraindications for rTMS (history of epilepsy, neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes)\n* Patients included or planning to be included in another medical research protocol\n* Patients unable to complete the protocol follow-up\n* Any brain pathological abnormality known or diagnosed by the cerebral MRI\n* Contre-indication for cerebral MRI (metallic fix tooth prosthesis, neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes, severe claustrophobia)",{"count":116,"type":22},120,[25],"Repetitive transcranial magnetic stimulation (rTMS) can alleviate persistent auditory verbal hallucinations (AVH) in schizophrenic patients, but the classical procedure with low-frequency stimulation for several weeks upon the left temporoparietal junction have shown modest therapeutic effects, and there is currently no robust predictive factor to the response of the treatment. In a previous multicentric, randomized, and double-blind controlled study, it has been demonstrated that a high-frequency rTMS over an anatomical target can rapidly affect AVHs. Moreover, an intensification of the classical procedure delivering 20-Hz rTMS over a 2-day period was used in addition to a personalized anatomical stimulation target and neuronavigation guidance. Besides the significant efficacy of the procedure, the efficacy was maximal at two weeks after the end of the treatment. In this project, the hypothesis is that the two-day cure could benefit from maintenance rTMS sessions every week for one month and then every two weeks for 3 months to provide an optimal strategy for a long-lasting AVH reduction. This has for now never been tested. Predictive factors to the response of the treatment are also investigated.",[32],[121,122,123],"Transcranial Magnetic Stimulation","Auditory verbal Hallucination","Neuronavigation","2025-07-22",{"date":126,"type":40},"2025-07-25",{"date":128,"type":40},"2023-10-30",{"date":130,"type":22},"2027-11-30",{"name":132,"class":47},"University Hospital, Caen",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":16,"sex":17,"minAge":57,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":48},"100497954","uppsala-psychosis-cohort-100497954","NCT05763966","Uppsala Psychosis Cohort","Uppsala Psychosis Cohort: a Multimodal Study in Early Stage Psychosis Patients, High Risk Individuals and Healthy Controls","UPC","Inclusion Criteria\n\nFor EPP:\n\n* Diagnosis as assessed using DSM-5 of one of the following: schizophrenia, schizophreniform psychosis, psychosis not otherwise specified (NOS), brief psychosis, schizoaffective syndrome, delusional disorder\n* Onset of psychotic symptoms together with functional decline no more than 3 years prior to inclusion visit\n\nFor CHR-P:\n\nClinical high risk for psychosis as determined using Structured Interview for Psychosis-risk Syndromes (SIPS).\n\nExclusion Criteria\n\nFor EPP and CHR-P:\n\n* Other dominant psychiatric illness that is deemed to be related to current psychotic symptoms (including bipolar disorder, major depressive disorder, autism)\n* Long-term daily treatment (\\\u003C2 weeks) with benzodiazepines, such that there is an inability to refrain from treatment during testing procedures.\n\nFor HC:\n\n* A history of diagnosis of a major psychiatric disorder, including substance use disorders.\n* A family history of psychotic disorders or bipolar disorder in first degree relatives.\n\nFor all participants:\n\n* Evidence based on medical history, clinical signs, MRI or laboratory tests of clinically significant somatic disorder, or previous disorder with brain engagement (e.g. tumour, neuroinflammatory disease, epilepsy) or significant brain trauma.\n* Exposure to an effective radiation dose of 25 mSv during the past year.\n* Pregnancy, lactating or breastfeeding (women).\n* Lack of proficiency in Swedish language, or documented intellectual disability that prohibits ability to give informed consent.\n* Meets diagnostic criteria of substance use disorder (excluding nicotine dependence) as assessed using DSM-5 or as determined using repeated positive urine screens during the course of the study.\n* Metallic object in the eye, or ferro\u002Felectromagnetic implants. History of claustrophobic anxiety during MRI.\n* Symptoms of severe bacterial, fungal, or viral infection (including upper respiratory tract infection), with systemic effects as detected by e.g. fever, within 7 days prior to inclusion.\n* Treatment with any antihemostatic medication within 2 weeks of lumbar puncture and arterial line placement of either the baseline or 1 year follow-up.\n* Blood donation (1 unit or more) within 90 days prior to Screening, plasma donation from 1 week prior to Screening, and platelet donation from 6 weeks prior to inclusion.\n* Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrollment. This may include very high symptom severity or signs of aggressiveness and hostility.","40 Years",{"count":116,"type":22},"OBSERVATIONAL","A multimodal longitudinal study in early stage psychosis patients and individuals at high risk for psychosis. Healthy controls are included for baseline comparisons. The aim is to investigate disease mechanisms of psychotic disorders, specifically focusing on the synaptic pruning hypothesis.",[32],"2025-02-17",{"date":148,"type":40},"2025-02-20",{"date":150,"type":40},"2023-04-01",{"date":152,"type":22},"2031-12-31",{"name":154,"class":47},"Uppsala University",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":89,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":106},"100542334","brain-circuitry-therapeutics-for-schizophrenia-100542334","NCT06341517","Brain Circuitry Therapeutics for Schizophrenia","Brain Circuitry Therapeutics for Schizophrenia - A Cross-species Longitudinal Randomized Controlled Clinical Study to Treat Negative Symptoms of Schizophrenia Using Non-invasive Stimulation of the Cerebellum","ATHENA","Inclusion Criteria:\n\n* Inclusion criteria\n\n  * Capable of giving informed consent as evaluated by the treating psychiatrist\n  * Informed Consent signed by the subject\n  * Patients aged 18 - 65 years diagnosed with a schizophrenia spectrum disorder (including schizophrenia, schizoaffective or non-organic psychosis, psychotic disorder NOS) according to DSM-5 criteria\n  * Clinically stable condition judged by their treating psychiatrist\n  * Background antipsychotic medication treatments have remained unchanged for at least 4 weeks\n  * No hospitalization in acute psychiatry ward at least 3 months prior to study entry\n\nSpecific exclusion criteria related to psychopathology\n\n* Comorbid and clinically active current major depressive episode determined by the treating psychiatrist.\n* Active psychotic symptoms. In particular, patients that at Baseline have a PANSS scores of more than 4 in any of the following PANSS items: delusions, suspiciousness\u002Fpersecution and hallucinatory behaviour will be considered not stable enough to participate.\n* Significant extrapyramidal side-effects quantified by total score of mSAS \\> 12.\n* Increased sedation due to use of medication (slowing, drowsiness, slurred speech etc.)\n* Active daily use of substances (i.e. cocaine), including for therapeutically medical purposes (e.g., methadone substitution)\n\nExclusion criteria related to MRI or TMS\n\n* History of fainting spells of unknown or undetermined aetiology that might constitute seizures\n* History of multiple seizures or diagnosis of epilepsy\n* Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease\n* Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* Metallic objects\u002Fimplants (excluding dental fillings) unless cleared to be MRI compatible (i.e. MRI compatible joint replacement)\n* Any implants controlled by physiological signs in\u002Fnear the head\n\n  * Pacemaker\n  * Implanted medication pump\n  * Vagal nerve stimulator\n  * Deep brain stimulator or TENS unit\n  * Ventriculo-peritoneal shunt\n  * Cochlear implant\n* Impaired ability to sense heat\u002Fpain, open wounds etc.\n* Increased intracranial pressure\n* Intracranial lesion, from a known genetic disorder or from acquired neurologic disease (e.g. stroke, tumor, cerebral palsy, severe head injury, or significant dysmorphology).\n* History of head injury resulting in prolonged loss of consciousness (\\>15minutes) or neurological sequelae\n* Ongoing pregnancy and breastfeeding. All participants capable of becoming pregnant will be required to have active contraception; any participant who is pregnant or breastfeeding will not be enrolled in the study.\n\nOther exclusion criteria\n\n* Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, cancer, pulmonary decompensation etc.)\n* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, intellectual retardation, dementia, etc. of the subject\n* Having legal obligation for psychiatric treatment.\n* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation.\n* Previous enrolment into the current investigation\n* Enrolment of the PI, his\u002Fher family members, employees and other dependent persons.",{"count":164,"type":22},70,[25],"This project is a double blind randomized clinical trials that examines the efficacy of cerebellar non invasive stimulation for apathy improvement in patients with schizophrenia",[32],"2024-11-14",{"date":170,"type":40},"2024-11-19",{"date":172,"type":40},"2024-04-15",{"date":174,"type":22},"2027-12-12",{"name":176,"class":47},"Indrit Begue",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":89,"enrollmentInfo":183,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":48},"100553166","phase-3-lumateperone-for-the-improvement-of-apathy-in-patients-with-psychotic-symptoms-100553166","NCT06482554","Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.","Inclusion Criteria:\n\n* Male or female subjects between the ages of 18-65 that have been diagnosed with Schizophrenia, Schizoaffective Disorder or Schizophrenia Spectrum and Other Psychotic Disorders.\n* A BPRS score \\> 35 at the screening visit.\n* An AES-C score \\> 32 at the screening visit.\n* If the subject is on a therapeutic regimen, that regimen must be stable for at least 30 days prior to screening. A therapeutic regimen may include medication, supplements, and\u002For probiotics.\n* In the opinion of the Investigator, the subject is able to participate in all scheduled evaluations, and likely to be compliant and complete all required assessments.\n* Female subjects of childbearing potential must not be pregnant or breast-feeding. Female subjects of childbearing potential must have a negative urine pregnancy test. Subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control, which includes abstinence, while being treated on this study and for 30 days after the last dose of study drug.\n* Must speak and understand English, as the consent and all evaluations will be conducted in English.\n* Must be willing to take and pass a urine drug screen with a negative result in order to rule out psychotic symptoms due to drugs of abuse.\n\nExclusion Criteria:\n\n* A BPRS score \\\u003C 35 at the screening visit.\n* An AES-C score \\\u003C 32 at the screening visit.\n* Have any clinically significant medical condition or an unstable intercurrent illness that would, in the opinion of the Investigator, preclude study participation.\n* Are currently taking more than one antipsychotic medication.\n* Are currently taking a long-acting injectable medication for psychotic symptoms.\n* Have a substance use disorder or show a positive drug screen for stimulants.\n* Are pregnant or of female sex with no evidence of measures for pregnancy prevention.\n* Presence of dementia.\n* Intellectual disability or cognitive impairment that would affect the symptom\u002Fapathy assessments, in the view of the investigator.\n* A diagnosis of Parkinson's disease.",{"count":184,"type":22},80,[62],"This study is looking to determine if Lumateperone improves motivation in patients with schizophrenia or schizoaffective disorders who show high levels of apathy as judged by AES-C-Apathy (Apathy Evaluation Scale - Clinician - Apathy) assessment and to examine a possible correlation between improvement in apathy scores and changes in elements of the PANSS (Positive and Negative Syndrome Scale) due to treatment with Lumateperone.",[188,95,32],"Apathy",[95,190,96,191],"Schizoaffective","Psychotic","2024-06-26",{"date":194,"type":40},"2024-07-01",{"date":196,"type":22},"2024-06",{"date":198,"type":22},"2026-12",{"name":200,"class":47},"Louisiana State University Health Sciences Center Shreveport",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":89,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":48},"100505200","hjernegym---effects-of-exergaming-in-psychosis-a-clinical-intervention-study-100505200","NCT05858255","Hjernegym - Effects of Exergaming in Psychosis: a Clinical Intervention Study","Inclusion Criteria:\n\n* Having consent capability\n* Understanding and speaking Scandinavian language\n* Fulfilling the International Classification of Diseases Tenth Revision (ICD 10) criteria for schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder and schizophreniform disorder)\n\nExclusion Criteria:\n\n* Diagnosis of intellectual disability\n* Diagnosis of neurological disorder\n* History of severe head trauma\n* Pregnancy\n* Chest pain during exercise\n* Unstable angina pectoris\n* Malignant hypertension\n* Uncontrollable arrhythmia\n* Recent myocardial infarction\n* Acute infection with lymphadenopathy\n* Other specified medical condition incompatible with participation",{"count":208,"type":22},48,[25],"The goal of this clinical intervention study is to investigate the effects of exergaming on cognition and other clinical symptoms in outpatient individuals with schizophrenia.\n\nThe main questions it aims to answer are: Will an exergaming intervention contribute to improved cognition and reduced clinical symptoms, as well as enhanced physical health\u002Fself-efficacy\u002Fquality of life, in individuals with schizophrenia? Will the gaming component strengthen motivation for a physically more intensive component, so that attendance will be at least as high as in comparable exercise studies despite the current study being implemented in a resource-limited, regular clinical outpatient setting? Participants will be asked to engage in two 45 minutes exergaming sessions with a designated personal trainer for 12 weeks. Results pre- and post intervention will be compared, and comparisons will also be made with a former randomized controlled trial conducted at the same site, in which the currently combined activities were investigated separately (high-intensity interval training and low-intensity video gaming), both yielding positive but different effects.",[32,65],"2023-05-04",{"date":214,"type":40},"2023-05-15",{"date":216,"type":40},"2023-03-29",{"date":218,"type":22},"2026-12-31",{"name":220,"class":47},"Sykehuset i Vestfold HF"]