[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizophrenia-spectrum-and-other-psychotic-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizophrenia-spectrum-and-other-psychotic-disorders":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,43,84,111,143,169,201,231],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100604643","phase-2-study-comparing-antipsychotic-dose-reduction-vs-maintenance-treatment-in-patients-with-schizophrenia-spectrum-disorder-a-personalized-medicine-approach-100604643",false,"NCT07152184","Study Comparing Antipsychotic Dose Reduction vs. Maintenance Treatment in Patients With Schizophrenia Spectrum Disorder: a Personalized Medicine Approach","A Prospective, Randomized, and Controlled Study Comparing Two Treatment Strategies (Dose REduction of Antipsychotics vs. Maintenance Treatment) in Patients With Schizophrenia Spectrum Disorder After Stratification Based on Patients' Psychotic PHENotype: a Personalized Medicine Approach","DREAMS-Phen","Inclusion Criteria:\n\n* \\- Patient 18-60 years of age;\n* Patient affiliated to health insurance (beneficiary or beneficiary's family);\n* Patient informed of the results of the preliminary medical examination;\n* Patient able to understand the aims and risks of the research (assisted by his\u002Fher curator, if applicable (if subject under curatorship\\*))\n* Informed consent signed by patient\n* Patient with a diagnosis of schizophrenia spectrum disorder (SSD): schizophrenia, schizophreniform, schizoaffective disorder or brief psychotic episode according to DSM-5;\n* Patient with:\n\n  1. Either a cycloid psychosis (CP) phenotype according to By-CP (score \\>=80%)\n  2. Or another (non-CP) psychotic phenotype; (By-CP score \\\u003C 80%)\n* Outpatient followed by an ambulatory psychiatrist;\n* Patient with an identified caregiver, defined as a person able to support the patient for the duration of the study, spending at least 8 hours per week with the patient or having easy access to the patient per phone.\n* Patient clinically stabilized, for at least 6 months, as defined by\n\n  a) low intensity of positive symptoms, i.e. PANSS P1, P2 and P3 items \\\u003C 4.\n* Patient treated with oral antipsychotics (in mono or polytherapy, with second- or first-generation antipsychotics);\n* Patients with a PSP score \\>70 at baseline will also be included\n* The participant agrees to follow the contraceptive requirements detailed in the protocol \\*Subjects under limited guardianship (i.e. French \"curatelle\") can participate to the study.\n\nExclusion Criteria:\n\n* \\- Patient hospitalized in a psychiatric ward;\n* Patient with a recent psychotic episode (during the last 6 months);\n* Patient treated with long-acting injection of antipsychotics (due to feasibility constraints and to the fact that these treatments remain essentially proposed to non-compliant patients with high risk of acute cessation and loss to follow-up);\n* Patient treated with clozapine (in mono or polytherapy - highly resistant patients, specificities of the relapses under clozapine\n* Patient considered by his psychiatrists to be at serious risk of harm to self or others (e.g. previous aggressive or suicidal behaviors); notably, a patient answering \"yes\" to C-SSRS suicidal ideation Type 4 or 5, having any suicidal behavior assessment within 6 months at Screening, or having been hospitalized or treated for suicidal behavior in the past 5 years before Screening. The investigator will rely on the results of the C-SSRS questionnaire completed at the time of inclusion (after consent has been signed) or previously completed as part of the patient's follow-up according to current practice.\n* Neurological or severe medical condition other than psychosis;\n* Pregnancy (verified by urinary test at enrollment for women of childbearing potential);\n* Current breastfeeding;\n* Patient involved in another Investigational Medicinal Product trial or having participated in another investigational drug trial, in which they received the investigational drug, within 60 days\n* Patient in an exclusion period defined by another research protocol;\n* Patient under guardianship (i.e. French 'tutelle');\n* Patient with care under constraint\n* Patients deprived of freedom because of a judicial measure.\n* Inability to give the patient the written consent form (emergency situation)\n* Patients with major depressive disorder (CDSS \\> 5) or manic episode (DSM-5-TR)\n* Patients with any of the following signs of substance abuse:\n\n  1. Current diagnosis or history of substance use disorder and\u002For substance intoxication as defined in the DSM-5-TR. If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the trial after consultation with the sponsor (Participant must also have negative urine drug screen at the screening.)\n  2. A positive urine screen for drugs of abuse at screening.\n  3. A history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer \\[354 mL\u002F12 oz\\], wine or sake \\[118 mL\u002F4 oz\\], or distilled spirits \\[29.5 mL\u002F1 oz\\] per day).\n  4. A positive Breathalyzer test for alcohol at screening. The investigator will screen urine for drug abuse and perform an alcohol test at the inclusion visit (after consent has been signed), and may also rely on previous results obtained in the course of patient follow-up according to standard practice.\n* The participant is a trial site employee, a site employee's immediate family member (for example, spouse, parent, child, sibling), or is in a dependent relationship with a site employee who is involved in conduct of this trial or may consent under duress.","ALL","18 Years","60 Years",{"count":21,"type":22},288,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The objective of this study is to respond to frequent requests from patients who wish to reduce or even stop their antipsychotic treatment once they have achieved clinical stability. Psychiatrists are reluctant to respond to these requests because the method for safely reducing or stopping antipsychotic treatment remains poorly understood.\n\nThe investigators want to verify the existence of an interaction between treatment strategy and psychotic phenotype (cycloid psychosis vs. non-CP), i.e., in terms of functional remission, the benefit of the dose reduction strategy compared to the maintenance strategy will be greater in the CP group than in the non-CP group.\n\nTo this end, patients will be randomly assigned to four groups based on their phenotype and treatment strategy (CP-dose reduction; CP-dose maintenance; non-CP-dose reduction; and non-CP-dose maintenance).\n\nSeveral hospitals throughout France are participating in this study, in which a random draw (called randomization) will be conducted to determine whether the physician will propose reducing the antipsychotic dose or maintaining it at the same dose for the patient.\n\nPatients included in this study will be adults aged 18 to 60 who have been diagnosed with a schizophrenic spectrum disorder (SS): schizophrenia, schizophreniform disorder, schizoaffective disorder, or brief psychotic episode.\n\nThe antipsychotics studied are:\n\n* second-generation antipsychotics: amisulpride, aripiprazole, olanzapine, quetiapine, risperidone;\n* first-generation antipsychotics: chlorpromazine, flupentixol, haloperidol, levomepromazine, loxapine, pipotiazine, zuclopenthixol.\n\n  288 patients will be included and followed for 24 months. The inclusion period is 48 months.\n\nFourteen follow-up visits are planned, every month for four months and then every two months. During these visits, self-questionnaires or cognitive tests will have to be completed by the patient, the caregiver, and\u002For the treating psychiatrist.\n\nThree blood samples will be taken at inclusion, at 6 months, and at the end of the study, in particular to measure the level of medication in the blood.",[28,29,30],"Patient With Schizophrenia Spectrum Disorder","NLM Classification WM 203, Psychology:Schizophrenic Psychology","Schizophrenia Spectrum and Other Psychotic Disorders","NOT_YET_RECRUITING","2026-05-22",{"date":34,"type":35},"2026-05-26","ACTUAL",{"date":37,"type":22},"2026-10-01",{"date":39,"type":22},"2032-02-01",{"name":41,"class":42},"University Hospital, Strasbourg, France","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":62,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100572985","biomarkersbiotypes-course-of-early-psychosis-and-specialty-services-100572985","NCT06740383","Biomarkers\u002FBiotypes, Course of Early Psychosis and Specialty Services","BICEPS","Inclusion Criteria:\n\n* Males and females, all races and ethnicities\n* 18-40 y\u002Fo\n* Meet DSM-5 criteria for a psychotic disorder, i.e. schizophrenia, schizophreniform, schizoaffective disorder, or bipolar I disorder or major depression with psychotic features, delusional disorder or psychosis N.O.S.\n* Able to read, speak, and understand English\n* Able and willing to provide written informed consent, and willing to commit to the study protocol\n* Illness duration from psychosis onset less than or equal to 4 years\n* At baseline only: receiving both psychopharmacology and psychotherapy\n\nExclusion Criteria:\n\n* Estimated premorbid intellectual ability \\\u003C70 (WRAT-4, Word Reading subtest, age-corrected standardized score)\n* Neurological or medical disorder that may affect brain function (seizure disorder, traumatic brain injury with a loss of consciousness greater than or equal to 30 min, history of stroke, AIDS, etc.)\n* Psychoses secondary to substance use i.e., Comorbid DSM-5 diagnosis of alcohol or substance use disorders that may explain the diagnosis of psychotic disorders (individuals with cannabis use disorders unrelated to psychosis onset will be allowed. Participants encouraged to abstain from substances for 24 hours prior to lab visits)\n\nMRI-Specific Exclusion Criteria:\n\n* Pregnant women\n* Presence of ferromagnetic objects in body\n* Weight or body size exceeding scanner capacity (\\>300 lbs)\n* Claustrophobia","40 Years",{"count":52,"type":22},320,"OBSERVATIONAL","The Biomarkers\u002FBiotypes, Course of Early Psychosis and Specialty Services (BICEPS) study aims to understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain electrical waves (EEG) data from individuals who have experienced these disorders in recent years. Participants will be involved for about a year, with four visits over this period. Screening procedures, lasting approximately 3 hours, include tests for drug use, a pregnancy test for eligible women, clinical interviews about feelings and experiences, psychiatric and family history interviews, and a medical history review. Research procedures for eligible participants include DNA collection, a neuropsychological test battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand brain function, genetics, and cognitive abilities related to psychotic disorders. Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical interviews and repeating neuropsychological tests to track changes over time. Participants may opt to provide DNA samples for genetic analysis, undergo various cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and MRI scans to visualize brain structure. Follow-up visits at regular intervals will help researchers track changes in symptoms and cognitive function. This study provides comprehensive insight into the onset and progression of psychotic disorders and offers valuable information for patients, families, and healthcare providers involved in managing these conditions. Our goal is to better understand whether a combination of biological markers and different types of people (BT1, BT2, BT3) can help us predict how well individuals with early psychosis respond to specialized care. We expect that those in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive issues, their biology might lead to different responses to treatment. This research can help us understand which treatments work best for different people with early psychosis.",[30,56,57,58,59,60,61],"Schizophrenia","Delusional Disorder","Bipolar 1 Disorder","Schizoaffective Disorder","Psychosis Not Otherwise Specified","Early Psychosis",[63,64,65,66,67,68,69,70,71,72],"schizophrenia","bipolar disorder","schizoaffective disorder","schizophreniform","major depression","psychosis","delusional disorder","Biotypes","Biomarkers","coordinated specialty care","RECRUITING","2026-03-06",{"date":76,"type":35},"2026-03-10",{"date":78,"type":35},"2023-01-01",{"date":80,"type":22},"2027-06-30",{"name":82,"class":42},"Beth Israel Deaconess Medical Center",6,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100559741","slomo2-implementation-effectiveness-and-cost-effectiveness-study-100559741","NCT06568081","SloMo2: Implementation, Effectiveness, and Cost-effectiveness Study","SloMo2: A Process Evaluation, Effectiveness, and Cost-effectiveness Study of a Digitally Supported Therapy for Psychosis in Routine Care","Inclusion Criteria:\n\n* Meet criteria for ICD-10 psychosis diagnoses (F20-29, F30-39)\n* Seeking therapy for paranoia\n* In contact with secondary care mental health services\n* Capacity to provide informed consent to engage in therapy\n\nExclusion Criteria:\n\n* Acute risk of harm to self or others\n* Unable to engage in therapy due to language barriers\n* Primary diagnosis of alcohol\u002Fsubstance dependence, learning disability, or organic brain injury or illness implicated in psychosis",{"count":92,"type":22},150,[94],"NA","Worries about harm from others (also known as paranoia) are common. Thinking fast or going on gut feelings is natural but can fuel these worries. For some, fast thinking and worries start to get in the way of life. Cognitive behaviour therapy for psychosis (CBTp) is the recommended talking therapy. However, only a minority of people can access CBTp due to limited resources, and even when available, therapy can be difficult to do and use in daily life.\n\nSloMo is a digitally supported therapy that aims to overcome these barriers, and was developed by people with psychosis, designers, and psychologists. It supports people to notice worries and fast thinking habits. During therapy sessions, people learn to slow down and feel safer. Personalised spinning thought bubbles are slowed down using SloMo tips. An app provides access to helpful messages.\n\nSloMo was previously tested in a randomised trial of 361 people attending mental health services. SloMo was found to be safe to use, with no adverse events linked to the software. People in the SloMo group had lower paranoia, and better confidence and wellbeing, over 6 months compared to people who just received their usual care. People found SloMo enjoyable and easy to use.\n\nThe next step is to evaluate if SloMo can be safely and effectively delivered by therapists working in NHS services. If SloMo works in routine care, the therapy will be made more widely available in the NHS.\n\nAn improved version of SloMo has been co-produced based on feedback. Sixty therapists will be trained and supervised in 3 trusts to deliver SloMo to 150 people who fear harm from others. Safety, technical performance, uptake, engagement and acceptability data, alongside interviews with patients, therapists, and managers, will investigate how SloMo is used. Paranoia severity and wellbeing will be measured pre, post therapy, and at 12 months follow up, to find out if SloMo helps. Service use data will evaluate costs and savings.",[30,97],"Affective Psychoses",[99,100],"Digital health","User-centred design","2026-01-23",{"date":103,"type":35},"2026-01-26",{"date":105,"type":35},"2024-10-16",{"date":107,"type":22},"2027-12-31",{"name":109,"class":42},"King's College London",1,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":127,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":110},"100564076","effectiveness-of-a-pragmatic-metabolic-care-clinic-for-patients-with-severe-mental-illness---the-meta-care-clinic-100564076","NCT06624462","Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic","Inclusion Criteria:\n\n* Patients with schizophrenia spectrum disorders (International classification of diseases; ICD-10: DF2x) or bipolar disorder (ICD-10: DF30.x or DF31.x)\n* Medical treatment with antipsychotics\n* Age 18-45 years\n* Legally competent\n* Able to give informed consent\n\nand either:\n\n\\- Body mass index (BMI) ≥30 kg\u002Fm2.\n\nOr\n\n* BMI ≥27 kg\u002Fm2 and at least one of the following:\n* Hypertension defined as treatment with ≥1 antihypertensive drug or out-of-office \u002F 24-hour, non-invasive ambulatory blood pressure ≥140\u002F90 mmHg within the previous 6 months\n* Dyslipidaemia defined as treatment with ≥1 lipid-lowering drug or elevated low-density lipoprotein (LDL) cholesterol (≥3.0 mmol\u002Fl), elevated triglycerides (≥1.7 mmol\u002Fl) or low high-density lipoprotein cholesterol (≥1.2 mmol\u002Fl in women and ≥1.0 mmol\u002Fl in men) within the previous 6 months\n* Sleep apnoea (ICD-10 DG473).\n* Prediabetes or diabetes defined as HbA1c ≥42 mmol\u002Fmol or impaired fasting glucose as defined by the International Diabetes Federation within the previous 6 months.\n\nOr\n\n\\- a history of rapid weight gain during antipsychotic therapy defined as increases of either ≥5% body weight or ≥5 cm waist circumference since initiation of antipsychotic therapy.\n\nExclusion Criteria:\n\n* Clinical or laboratory evidence of comorbid medical disease not compatible with participation as judged by the research team.\n* Unstable psychiatric disorder as judged by the research team.\n* Severe current drug or alcohol misuse as judged by the research team.\n* Acute suicidal risk.","45 Years",{"count":119,"type":22},84,[94],"This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness",[123,124,125,30,126],"Severe Mental Disorder","Metabolic Complication","Side-Effect;Medication","Bipolar Disorder",[128,129,130,131,132,133],"Severe mental illness","Overweight and obesity","Antipsychotic medication","Dysmetabolism","Schizophrenia Spectrum Disorders","Bipolar disorder","2026-01-06",{"date":136,"type":35},"2026-01-08",{"date":138,"type":35},"2023-10-10",{"date":140,"type":22},"2026-12-31",{"name":142,"class":42},"Bjorn H. Ebdrup",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":150,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":151,"targetDuration":153,"studyType":53,"phases":4,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":110},"100567882","immunoinflammatory-state-detection-and-multimodal-brain-imaging-and-electrophysiologic-changes-in-schizophrenia-100567882","NCT06673966","Immunoinflammatory State Detection and Multimodal Brain Imaging and Electrophysiologic Changes in Schizophrenia","SZIM","Inclusion Criteria:\n\n1. Clinical diagnosis that meets ICD-11 criteria for schizophrenia.\n2. Confirmation of the diagnosis of schizophrenia using the SCID-5-RV.\n\nExclusion Criteria:\n\n1. Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco).\n2. Presence of severe or acute physical illnesses, including traumatic brain injury, intracranial space-occupying or infectious diseases, acute cardiovascular diseases, acute respiratory system diseases, acute hematological disorders, autoimmune disease, etc.\n3. Presence of clearly defined genetic diseases, including tuberous sclerosis, multiple sclerosis, Kleefstra syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome, Klinefelter syndrome (47, XXY), etc.",true,{"count":152,"type":22},200,"3 Months","Schizophrenia is a severe mental illness that seriously affects the health and functioning of patients. Previous studies have found immunoinflammatory abnormalities in the blood, cerebrospinal fluid, central nervous system, and neuroimaging of people with schizophrenia, along with therapeutic effects of anti-inflammatory drugs on schizophrenia. These evidences suggest a close relationship between schizophrenia and immunity and inflammation. Therefore, we consider that the state of immune inflammation is a potential subtype classification basis for schizophrenia, and hypothesize that immune classification based on peripheral-central multidimensional data is related to patient's response to medication and cognition.",[56,30,156],"Mental Disorders",[56,158,159],"immunity","inflammation","2025-04-22",{"date":162,"type":35},"2025-04-24",{"date":164,"type":35},"2025-01-10",{"date":166,"type":22},"2028-12-31",{"name":168,"class":42},"Central South University",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":180,"conditions":181,"keywords":187,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":110},"100512377","sex-psychopharmacology-and-diabetes-100512377","NCT05951660","Sex, Psychopharmacology, and Diabetes","The Effect of Targeted Education on Number, Severity, and Perception of Sexual Side Effects of Patients Suffering From Schizophrenia and Diabetes or Prediabetes.","SECRET","Inclusion Criteria:\n\n* Age ≥ 18 years\n* A diagnosis in the schizophrenic spectrum (ICD10 F2x)\n* One of the following:\n\n  1. A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x)\n  2. A current or previous prediabetes defined as an HbA1c between 39-47 mmol\u002Fmol (both included) measured in at least two blood samples collected with ≥3 months intervals as part of the patient's routine clinical monitoring\n  3. Obesity defined as a Body-Mass Index (BMI) ≥30 kg\u002Fm2\n* Ongoing treatment with at least one antipsychotic agent\n* A SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14)\n\nExclusion Criteria:\n\n* Incapacitated or subject to mental health probation\n* Unable to speak danish",{"count":178,"type":22},256,[94],"The term sexual (SD) dysfunction covers conditions that prevent people from having a satisfactory sex life. SD is a frequent and sometimes debilitating complication of mental illness and a known adverse reaction to psycho-pharmacological treatment. SD is also associated with diabetes, a common somatic comorbidity in psychiatric patients. SD is associated with both reduced quality-of-life and reduced treatment adherence, yet SD is far too rarely addressed between the patient and the healthcare professional in clinical consultations.\n\nThe purpose of the study is to investigate whether targeted education of patients with schizophrenia and diabetes\u002Fprediabetes and\u002For their healthcare professionals in causes and management of SD:\n\n* Increases the number of systematic examinations of sexual side effects,\n* Causes changes in the psycho-pharmacological treatment, and\n* Reduces the severity or perception of sexual side effects.\n\nThe study is a multicenter Randomized Controlled Trial (RCT) with four arms, in which the educational intervention is provided to patients, healthcare professionals, or both groups. The effect of the educational intervention is compared to a non-educated control group. The study is expected to include 192 patients recruited from 16 assertive community treatment centers evenly distributed in four Danish regions.\n\nThe study is part of an interdisciplinary project named SECRET. The educational intervention was developed in an ethnographic pre-study incorporating stakeholder engagement. Parallel to the present RCT, an ethnographic field study will be carried out to broaden the perspective on the effects of the intervention.",[56,30,182,183,184,185,186],"Diabetes Mellitus","PreDiabetes","Sexual Dysfunction","Drug-Related Side Effects and Adverse Reactions","Education",[188,189,190,191],"Randomized Controlled Trial","Treatment Adherence and Compliance","Antipsychotic Agents","Patient Education as Topic","2025-02-07",{"date":194,"type":35},"2025-02-11",{"date":196,"type":35},"2023-08-24",{"date":198,"type":22},"2025-07-31",{"name":200,"class":42},"Zealand University Hospital",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":83},"100562496","the-personalized-psychological-treatment-for-psychosis-100562496","NCT06603922","The Personalized Psychological Treatment for Psychosis","Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis","PERMEPSY","Inclusion Criteria:\n\n1. Inpatients and outpatients with a DSM-IV-R and DSM-5 diagnosis of non-affective psychosis or Clinical High Risk for psychosis.\n2. Presence of positive symptoms during the last year (PANSS delusions, suspiciousness or grandiosity \\>=3).\n3. Adults, 18 - 65 years of age\n4. Stable condition with no expected changes in medication (information from clinical services).\n5. Lack of severe cognitive deficits (global assessment or\u002Fand information from clinical services);\n\nExclusion Criteria:\n\n1. Having received MCT in the previous year.\n2. Neurological disorder, a history of head trauma or premorbid IQ below 70 (based on medical reports and\u002For other sources);\n3. A score above 5 in the \"Hostility\" and the \"Suspiciousness\" items of the PANSS Positive subscale (to preserve group dynamics).\n4. aggressive behavior (reports from clinical services if available)\n5. High risk of suicide (verified with DIAMOND)","65 Years",{"count":211,"type":22},252,[94],"The main aim of the clinical trial is to validate the Machin Learning (ML) predictive model for personalized Metacognitive Training (MCT) by comparing classic MCT to personalized MCT (P-MCT) among patients diagnosed with psychosis who had a history of delusions. More precisely, we will compare classic MCT to P-MCT in a randomized clinical trial.We expect personalised MCT treatment will see more improvement than classical MCT in outcome variables measuring treatment efficacy.",[56,215,30],"Psychosis",[217,218,219,220,221],"personalized medicine","psychological treatment","metacognitive training","machine learning","software platform","2024-09-16",{"date":224,"type":35},"2024-09-19",{"date":226,"type":22},"2024-10-01",{"date":228,"type":22},"2026-05-31",{"name":230,"class":42},"Polish Academy of Sciences",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100554936","vr-based-avatar-therapy-for-treatment-of-auditory-hallucinations-100554936","NCT06505564","VR-based Avatar Therapy for Treatment of Auditory Hallucinations","VR-based Avatar Therapy for Treatment of Auditory Hallucinations in Patients With Schizophrenia 2023-SUD-3446","Inclusion Criteria:\n\n* Diagnosis of schizophrenia spectrum disorder according to DSM-5,\n* Age 18 or older,\n* The fluent use of the spoken language at the site (Hungarian\u002FSpanish\u002FPolish),\n* Informed consent provided by the patient or their caregiver after being informed about the research procedure\n* Stable medication dosage for at least 4 weeks prior to recruitment,\n* Regular psychiatric follow-up,\n* Experience of auditory hallucinations for at least three months (PANSS hallucination score of at least 3 points),\n* Meeting the remission criteria described by Andreasen, except for the score related to auditory hallucinations\n\nExclusion Criteria:\n\n* Inability to identify a single dominant voice that is the subject of the intervention,\n* Lack of cooperation,\n* Intellectual disability based on medical history,\n* Regular substance abuse\n* Central nervous system injury or neurological disease that affects cognitive performance,\n* Suicidal risk\n* Aversion to virtual reality,\n* Severe visual impairment",{"count":239,"type":22},90,[94],"The primary aim of this study is to evaluate the safety and efficacy of AVATAR therapy, developed to address residual auditory hallucinations persisting despite medication in schizophrenia spectrum disorder. The intervention aims to reduce the intensity and frequency of these symptoms, as well as alleviate associated depressive and anxiety symptoms, using a virtual reality (VR)-assisted intervention developed for this purpose by the Danish company HEKA VR. The study will be a pre-post non-invasive, waiting list-controlled study, enrolling 30 patients from three clinical sites (Hungary, Spain, Poland).\n\nThe study centers around administering therapy based on VR over a 12-week period, comprising a total of 7 sessions. These sessions are conducted individually and last 50 minutes each. The psychotherapist leading the sessions adheres to a strict protocol defined by the method's developers.\n\nDuring the intervention, VR technology is used to simulate the source of distressing auditory hallucinations. The therapist facilitates coping with these experiences externalized in this way through simulated conversations, supporting the development of more adaptive responses.\n\nPatients undergo a comprehensive cross-sectional evaluation of their condition before and after the intervention, including assessments of symptom severity, quality of life, and their experience with the method. The intervention is conducted with constant monitoring for possible adverse effects.",[243,30],"Hallucinations, Auditory",[245,246,247,248],"Virtual reality","AVATAR therapy","Auditory verbal hallucation","Schizophrenia spectrum disorder","2024-07-17",{"date":251,"type":35},"2024-07-19",{"date":253,"type":35},"2024-03-01",{"date":255,"type":22},"2025-12-31",{"name":257,"class":42},"Semmelweis University",4]