[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizophrenia-spectrum-disorders-ssd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizophrenia-spectrum-disorders-ssd":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,60,86,108],{"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":35,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100642980","feel-good-a-multicenter-trial-of-a-mindfulness-based-group-therapy-in-young-adults-with-early-psychosis-100642980",false,"NCT07645443","FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis","Mindfulness-based Group Therapy in Young Inpatients With Acute Early Psychosis (FEEL-GOOD)","FEEL-GOOD","Inclusion Criteria:\n\n* Age 16 to 35 years\n* Clinical diagnosis of early psychosis, defined as first psychotic episode within the last 5 years as assessed with the Structural Clinical Interview for DSM-5 Research Version (SCID-5-RV)\n* DSM-5 schizophrenia spectrum or other psychotic disorder confirmed with SCID-5-RV (DSM-5: 297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) Currently receiving inpatient\u002Fday clinic treatment with a planned stay of at least 4 weeks\n* Interested in and willing to participate in FEEL-GOOD and\u002For TAU.\n\nExclusion Criteria:\n\n* Insufficient German language abilities\n* Acute suicidality or acute threat to others","ALL","16 Years","35 Years",{"count":21,"type":22},252,"ESTIMATED","INTERVENTIONAL",[25],"NA","FEEL-GOOD is a prospective multi-site single-blinded randomized controlled trial in young inpatients with acute early psychosis. Participants are randomized 1:1 to FEEL-GOOD plus treatment as usual (TAU) or TAU alone. The intervention consists of one individual preparatory session and eight modularized group sessions delivered over four weeks involving four to eight participants at each session and including practice and homework tasks. Outcomes are assessed at baseline, 4 weeks post-intervention, and 6 months follow-up, with the primary outcome being observer-rated total psychopathology as measured with the assessed by the total score of the Positive and Negative Syndrome Scale (PANSS) post-treatment (4 weeks post baseline).",[28,29,30,31,32,33,34],"Early Onset Psychosis","First Psychotic Episode Within the Last 5 Years","First-episode Psychosis","Schizophrenia Spectrum Disorders (SSD)","Psychosis","Psychosis NOS","Randomized Controlled Trial (RCT)",[36,37,38,39,40,41,42,43,44,32,45,46],"Randomized controlled trial","Emotion regulation","Ecological momentary assessment","Early psychosis","First-episode psychosis","Mindfulness-based intervention","PANSS","EMA","Schizophrenia spectrum disorder","Mindfulness","observer-rated","RECRUITING","2026-06-09",{"date":50,"type":51},"2026-06-12","ACTUAL",{"date":53,"type":51},"2026-05-27",{"date":55,"type":22},"2028-12-31",{"name":57,"class":58},"Stephanie Mehl","OTHER",8,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":68,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":23,"phases":71,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100620672","multimodal-physical-exercise-program-physical-exercise-for-psychosis-for-people-with-psychosis-treated-with-long-acting-injectable-antipsychotics-100620672","NCT07360665","Multimodal Physical Exercise Program (Physical Exercise for Psychosis) for People With Psychosis Treated With Long-Acting Injectable Antipsychotics","PEP - Physical Exercise for Psychosis: A Study Protocol","PEP","Inclusion Criteria:\n\n* Age 18 years or older;\n* Clinical diagnosis of psychosis;\n* Currently undergoing treatment with long-acting injectable antipsychotics (LAIs);\n* Follow-up at the Antipsychotic Clinic of ULSTMAD;\n* Certificate of autonomy issued by the treating psychiatrist, confirming the participant's capacity to engage in the study procedures;\n* Ability to provide written informed consent, either personally or through a legal representative;\n* (Experimental group only) Residence within a reasonable distance from the physical exercise intervention site to allow attendance at supervised sessions.\n\nExclusion Criteria:\n\n* Attendance below 85% of the supervised exercise sessions (experimental group);\n* Failure to complete the four main assessment time points;\n* Withdrawal or lack of informed consent at any stage of the study;\n* Not prescribed long-acting injectable antipsychotics (LAIs);\n* Not affiliated with or followed at the Antipsychotic Clinic of ULSTMAD.","18 Years",{"count":70,"type":22},44,[25],"People with psychotic disorders, such as schizophrenia, often experience significant difficulties in daily functioning, physical health, and quality of life. Long-acting injectable antipsychotics are an important part of treatment, but they can be associated with metabolic side effects and reduced physical fitness. Physical exercise has shown potential benefits for mental and physical health in this population; however, structured exercise programs implemented in real-world psychiatric services are still limited.\n\nThe purpose of this study is to evaluate the feasibility and clinical impact of a structured, multimodal physical exercise program for adults with psychosis who are receiving long-acting injectable antipsychotic treatment. The study aims to determine whether participation in a supervised exercise program can improve physical functioning, psychological well-being, and selected biological markers related to brain health and metabolism.\n\nThis study will be conducted in an outpatient psychiatric setting in Portugal and will include adults diagnosed with psychosis who are currently treated with long-acting injectable antipsychotics. Participants will be allocated to either an exercise group or a control group receiving usual care. The exercise program will last 24 weeks and will include aerobic, strength, mobility, and flexibility exercises, with supervised sessions conducted by qualified professionals.\n\nParticipants will be assessed at baseline, during the intervention, after completion of the program, and at follow-up. Assessments will include measures of physical function, body composition, psychological well-being, quality of life, and blood-based biomarkers such as brain-derived neurotrophic factor, dopamine, serotonin, and metabolic indicators.\n\nThe main hypothesis of this study is that individuals who participate in the physical exercise program will show improvements in physical function, mood, and overall well-being compared with those receiving usual care alone. The results of this study are expected to provide practical evidence to support the integration of structured physical exercise as an adjunct to routine psychiatric care for people with psychosis.",[74,31,75],"Psychotic Disorders","Severe Mental Illness","2026-04-28",{"date":78,"type":51},"2026-04-29",{"date":80,"type":51},"2026-01-01",{"date":82,"type":22},"2026-11-30",{"name":84,"class":58},"University of Trás-os-Montes and Alto Douro",1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":68,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":106,"locationsCount":85},"100613330","oxytocin-augmented-group-psychotherapy-for-patients-with-schizophrenia---an-oxytocin-dose-comparison-100613330","NCT07265180","Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison","Oxytocin-Augmented Mindfulness-Based Group Psychotherapy for Patients With Schizophrenia Spectrum Disorders - an Oxytocin-dose Comparison (OXYMIND2.0)","OXYMIND2","Inclusion Criteria:\n\n* Declaration of consent\n* Psychiatric diagnosis of schizophrenia (ICD-10: F2x.x spectrum) for group of patients\n* Mild to moderate positive symptoms (5 ≤ Positive symptoms on individual items using P-PANSS)\n* German should either be the native language or spoken at a native level\n* No change in systematically recorded psychopharmacological medication in the last 2 weeks before study inclusion\n\nExclusion Criteria:\n\n* Acute psychotic episode with severe positive symptoms (ICD-10: F2 spectrum, 6 ≥ positive symptoms on individual items using P-PANSS)\n* Acute suicidality\n* Acute consumption phase of a substance dependence, except nicotine\n* No severe physical impairments, neurological diseases and e.g. severe craniocerebral trauma e.g. early childhood brain damage\n* Pregnancy and breastfeeding\n* Current acute electroconvulsive therapy\n\nIf one of the following criteria applies to the participants, we will conduct an individual consultation in advance to determine whether participation in the study is possible:\n\n* Overweight or underweight (body mass index (BMI) \\\u003C 17.5 or \\> 30)\n* Disease of the endocrine system\n* Impaired kidney or liver function\n* Metabolic diseases\n* Asthma\n* Change in blood potassium or sodium levels","75 Years",{"count":96,"type":22},120,[25],"The effectiveness of current treatment options for sociocognitive deficits and negative symptoms (NS) in schizophrenia spectrum disorders (SSD) remains limited. The cause of NS is thought to be an interference between the mesocorticolimbic dopamine system for social reward expectancy and the network for socioemotional processes. Oxytocin (OXT) may enhance functional connectivity between these neuronal networks. Lower plasma OXT levels correlate negatively with NS severity and deficits in social cognition in SSD. It has been shown that intranasal OXT administration improves social cognition in healthy subjects but in SSD results are inconsistent. According to the social salience hypothesis, the effect of OXT varies depending on the social context and individual factors. Also, OXT-mediated effects on psychopathology and NS may depend on genetic variants of OXT receptors (OXTR). In a pilot study, the investigators demonstrated lower NS by OXT administration in a positive social context of mindfulness-based group psychotherapy (MBGT) in SSD. The investigators also demonstrated that symptoms improved after MBGT. A more recent study suggests that, compared to placebo, administering OXT in a positive social context via MBGT leads to significant between-group differences favoring OXT, particularly in NS, affect, and stress. Building on these findings, the present study investigates the stability of these effects, along with psychological and biological markers, in a larger sample of individuals with SSD. The main hypothesis to be tested is that the use of OXT compared to placebo prior to MBGT in patients with SSD will result in a greater reduction in NS with a higher OXT dosage. The research design is based on an experimental, triple-blind, randomized, placebo-controlled trial.",[31],"2025-11-24",{"date":102,"type":51},"2025-12-04",{"date":104,"type":51},"2025-09-08",{"date":82,"type":22},{"name":107,"class":58},"Charite University, Berlin, Germany",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":68,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":85},"100583859","phase-2-enhancing-social-skills-in-schizophrenia-spectrum-disorders---oxytocin-as-add-on-to-psychosocial-treatment-100583859","NCT06881810","Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment","Enhancing Social Skills in Schizophrenia Spectrum Disorders - Two-arm, Double-blind, Randomized Clinical Trial Investigating Oxytocin vs. Placebo as an add-on to an Individualized Psychosocial Treatment (OXY-APS)","OXY-APS","Inclusion Criteria:\n\n1. Age 18 to 64 years\n2. Written informed consent (must be available before enrolment in the clinical trial)\n3. ICD-11 diagnosis of schizophrenia or other primary psychotic disorders (6A20-6A25) confirmed by the MINI-DIPS-OA Interview\n4. At least one symptom of moderate severity or worse in the PANSS negative subscale (a score ≥ 4 for one or more symptoms from N1-N7 at baseline).\n5. In- or outpatient psychosocial treatment on a regular basis at least twice a week during the study\n6. Male participants and female participants who are not capable of bearing children or female patients of childbearing potential who use a highly effective birth control method that is medically approved by the health authority at screening.\n\n1\\. Age 18 to 64 years 2. Written informed consent (must be available before enrolment in the clinical trial) 3. ICD-11 diagnosis of schizophrenia or other primary psychotic disorders (6A20-6A25) confirmed by the MINI-DIPS-OA Interview 4. At least one symptom of moderate severity or worse in the PANSS negative subscale (a score ≥ 4 for one or more symptoms from N1-N7 at baseline). 5. In- or outpatient psychosocial treatment on a regular basis at least twice a week during the study 6. Male participants and female participants who are not capable of bearing children or female patients of childbearing potential who use a highly effective birth control method that is medically approved by the health authority at screening.\n\nExclusion Criteria:\n\n1. Patients who are not suitable for the study in the opinion of the investigator (including acutely suicidal patients)\n2. Coercive treatment at the time of study inclusion\n3. Diagnosis of primary substance dependency other than nicotine: exclusion alcohol dependency via AUDIT-screening (Bohn, Babor et al. 1995; Babor et al. 2001) and ICD- 11 criteria (MINI-DIPS-OA); exclusion of other drug dependencies other than alcohol and nicotine: drug screening of urine and ICD-11 criteria (MINI-interview: patient fulfilling early (\\> 3 months) or sustained (\\>12 months) remission criteria and\u002For with low severity of substance use disorder according to MINI (ICD-11) are eligible for the study).\n4. Documented intolerance to the study drug or any of its ingredients.\n5. Pregnancy (incl. positive urine or blood pregnancy test) \u002F breastfeeding (female patients) or lactating individuals\n6. Severe endocrinological disorder besides diabetes\n7. Endometriosis\n8. Concurrent participation","64 Years",{"count":118,"type":22},98,[120],"PHASE2","Research on schizophrenia spectrum disorders (SSD) patients with social impairment is essential for improving treatment, enhancing the lives of affected individuals, reducing stigma, and advancing our understanding of this complex psychiatric disorder. A clinical trial focusing on the improvement of social skills in SSD has the potential to transform clinical practice and support systems to better meet the needs of those living with SSD. Because of the role of oxytocin in regulating social behaviors and emotions, the investigator hypothesizes that it is beneficial in addressing the social cognition deficits observed in SSD when combined with psychosocial interventions.",[31],"2025-03-18",{"date":125,"type":51},"2025-03-21",{"date":127,"type":51},"2024-08-29",{"date":129,"type":22},"2028-03-31",{"name":131,"class":58},"Central Institute of Mental Health, Mannheim"]