[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychotic-episode\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychotic-episode":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,71,103],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100506925","pilot-and-descriptive-study-of-the-effects-of-setting-up-computer-assisted-music-cam-remediation-groups-on-the-cognitive-functioning-of-young-patients-with-a-first-episode-psychosis-pep-100506925",false,"NCT05880719","Pilot and Descriptive Study of the Effects of Setting up Computer-assisted Music (CAM) Remediation Groups on the Cognitive Functioning of Young Patients With a First Episode Psychosis (PEP)","Pilot and Descriptive Study of the Effects of the Implementation of Computer Assisted Music Remediation Groups on the Cognitive Functioning of Young Patients Presenting a First Episode Psychosis","MAOPEP","Inclusion Criteria:\n\n* Patient aged 18 to 30 years.\n* Consult for a first psychotic episode according to the criteria of the DSM-V\n* Francophone patient\n* With at least one memory deficit highlighted at the neuropsychological assessment of entry into the EMSI\n* Benefiting from a follow-up within the EMSI\n* Affiliated to the social security system\n* Clinically stabilized patient one month away from psychiatric hospitalization\n* Patient who has been informed of the study and has given his informed consent.\n\nExclusion Criteria:\n\nInability to give the patient informed information\n\n* Not meeting the criteria of the DSM-V of first episode of psychosis\n* Absence of memory cognitive disorders at the neuropsychological assessment of entry into the EMSI department.\n* Patient who has already had cognitive remediation in his EMSI management.\n* Patients under judicial protection measure (guardianship or curatorship).","ALL","18 Years","30 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","The use of music in the field of cognitive remediation is growing and much research has focused on the relevance and effectiveness of its use in care. Studies have therefore made it possible to show the relevance of the use of musical material in the remediation of patients with various pathologies with cognitive disorders (head trauma, stroke, Alzheimer's disease). Although cognitive remediation has been widely studied in patients with schizophrenia, few studies suggest the effects of remediation in patients with a first psychotic episode. No study currently demonstrates the relevance of this material in the remediation of young people presenting a first psychotic episode.\n\nThe Mobile Intensive Care Team of the Adult Psychiatry Service of the CHU de Caen (EMSI) takes care of patients who have presented with a first psychotic episode. Young people entering an emerging psychosis frequently exhibit cognitive impairment. These attacks are variable and can concern memory, attentional and executive functioning. The most frequent disorders concern memory functioning and it is important to deal with them early in order to improve the functional prognosis of the young person.\n\nWe therefore propose the establishment of cognitive remediation groups through the MAO with patients treated by EMSI. These groups would aim to heal memory, attention and executive functions through exercises and musical practice through the Ableton © software. We therefore propose a study that would assess the effects of these workshops on the cognitive functioning of patients with memory difficulties. Attentional and executive functioning as well as self-esteem and negative symptoms will also be assessed.\n\nThis remedy will be offered in groups of 4. In this feasibility study, 30 patients will be included depending on the inclusion and monitoring capacities of the center. Ten weekly sessions of one hour per group over a period of 3 months will be applied. To assess the beneficial effects of this group remediation, assessments will be carried out at the start of the study and at the end of the 10 sessions.\n\nThe aim of this study is to assess the effects of an CAM remediation group on cognitive functioning, mood and self-esteem in patients who presented with a first psychotic episode.",[28],"Psychotic Episode",[30,31,32,33],"Music","Computer Aided Music","Memory","First Psychotic Episode","RECRUITING","2026-06-17",{"date":37,"type":38},"2026-06-22","ACTUAL",{"date":40,"type":38},"2023-05-25",{"date":42,"type":22},"2028-06-30",{"name":44,"class":45},"University Hospital, Caen","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100448212","evaluation-of-the-impact-of-case-manager-intervention-on-the-3-year-psychotic-episode-recurrence-rate-in-patients-aged-16-to-30-years-with-a-first-psychotic-episode-100448212","NCT05116514","Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.","Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode. Randomized, Open-label, Multicenter Controlled Study With Blinded Evaluation.","PEPsy-CM","Inclusion Criteria:\n\n* The patient or their close relative must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n* The patient is available for a 3-year follow-up.\n* Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by:\n\n  * Presence of positive psychotic symptoms (delusion(s) and\u002For hallucination(s) and\u002For conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ;\n  * Never having taken a neuroleptic treatment with antipsychotic aim (except for an antipsychotic treatment started for the current episode for example by the general practitioner before being referred to psychiatry);\n  * A disorder meeting the DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder greater than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder greater than 7 days, other specific or nonspecific schizophrenic spectrum disorder or other psychotic disorder, bipolar I or II disorder with congruent and non-mood congruent psychotic features, bipolar disorder with congruent and non-mood congruent psychotic features induced by a substance, major depressive disorder with congruent and non-mood congruent psychotic features.\n* Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service.\n* At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission.\n\nExclusion Criteria:\n\n* The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study\n* The subject, or one of the parents for minor patients, refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* The patients has an IQ less than or equal to 55\n* The patient has a first psychotic episode linked to a psychotic problem triggered by a medication of other medical condition\n* The patient is pregnant or breastfeeding","16 Years",{"count":57,"type":22},256,[25],"The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding. The intervention of case managers according to the recommendations of good practices will make it possible to propose the fundamental principles of early intervention to young patients and their families on a large scale throughout the territory, namely: personalized and proactive accompaniment, psycho-education of the pathology and treatments, involvement and support of the families, and support for socio-professional reintegration",[28],"2025-12-29",{"date":63,"type":38},"2025-12-31",{"date":65,"type":38},"2021-09-27",{"date":67,"type":22},"2028-11",{"name":69,"class":45},"Centre Hospitalier Universitaire de Nīmes",6,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100575921","phase-3-stratification-and-treatment-in-early-psychosis-study---enhance-100575921","NCT06778564","Stratification and Treatment in Early Psychosis Study - ENHANCE","Augmentation With Cannabidiol in First Episode Psychosis: a Double-blind, Randomised Controlled Trial","STEP-ENHANCE","Inclusion criteria:\n\n1. The participant is 16 to 40 years of age, willing and able to provide written informed consent\u002Fassent.\n2. The participant is currently being treated with an antipsychotic for at least 3 weeks but no longer than 16 weeks.\n3. The participant should be receiving at least the minimum dose of this antipsychotic for FEP according to modified Maudsley guidelines, as listed in Appendix B. The clinician should judge the participant to be a non-responder to this treatment and that increasing the dose further is unacceptable to the clinician and\u002For participant.\n4. The compliance score associated with this antipsychotic medication is 4 or more on the Clinician Rating Scale (CRS).\n5. The participant meets DSM-5 criteria for schizophrenia, schizoaffective disorder or schizophreniform disorder, as confirmed through the SCID-5-RV.\n6. The participant does not meet modified Andreasen criteria for symptomatic remission (time requirement does not apply).\n7. Participants of childbearing potential (\\*) must be willing to ensure that they use highly effective contraception during the trial and as per the requirements in the protocol\\*\\*.\n8. In the Investigator's opinion, is able and willing to comply with all trial requirements.\n9. Willing to allow their General Practitioner and\u002For consultant, if required by local guidelines\u002Fregulations, to be notified of participation in the trial.\n10. For participants who take part in the optional MRI scans: they must be eligible for MRI scanning as per local requirements, for example concerning e.g. implants, braces etc.\n\nThere is inadequate information on the effects of cannabidiol on the foetus in humans. Participants of childbearing potential\\* should use a highly effective method of contraception\\*\\* for the duration of the trial and for 3 months after the last time the trial intervention was used.\n\n\\*A person is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n\n\\*\\* Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: 1) combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral; intravaginal; transdermal); 2) progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; implantable); 3) intrauterine device (IUD); 4) intrauterine hormone-releasing system (IUS); 5) bilateral tubal occlusion; 6) vasectomised partner; 7) sexual abstinence (abstinence should only be used as a contraceptive method if it is in line with the participants' usual and preferred lifestyle).\n\nPeriodic abstinence (calendar, symptothermal, post-ovulation methods) is not an acceptable method of contraception. The participant agrees to use an acceptable method of contraception\\* for the duration of the study and for 3 months after any study drug administration, unless surgically sterile or postmenopausal (no menses for 12 months without an alternative medical cause).\n\nThe age range for eligibility has been applied as this corresponds to the usual age range for first episode psychosis; individual cases outside of this age range may have a different aetiology and\u002For prognosis which could impact on the study outcomes.\n\nExclusion criteria:\n\n1. Having been previously treated with a different antipsychotic (to the current one) at an adequate dose\\* for 4 weeks or longer.\n2. Current or previous treatment with clozapine and\u002For current treatment with sodium valproate, valproate semisodium, or clobazam. In cases of current use of these medicines, participation is only permitted if they can and will be discontinued or switched to a suitable alternative medication prior to randomisation.\n3. Hypersensitivity to the active substance, sesame oil, sesame seed or any of the excipients of the intervention.\n4. Known hepatic insufficiency and\u002For transaminase elevations levels exceeding the upper limit of normal 2 times or more and bilirubin greater than 1.5 times the upper limit of normal.\n5. Previous neurosurgery or neurological disorder, including epilepsy, which may affect the study procedures\\*\\*.\n6. IQ \\\u003C70.\n7. Pregnancy or breastfeeding.\n8. The patient has a current diagnosis of 'Substance or medication induced psychotic disorder' or 'Psychotic disorder due to another medical condition' as determined through the SCID-5-RV.\n9. Current active suicidal ideation within the last 2 weeks, defined as a score of 1 or higher on CDSS question 8, followed by an assessment by the treating clinician who determines it is not safe for the patient to participate in the study\\*\\*\\*.\n10. Meeting DSM-V criteria for substance use disorder, with the exception of nicotine use disorder (mild, moderate, and severe allowed). Mild cannabis use disorder is allowed (i.e. can meet up to but no more than 3 criteria on the SCID) as long as the subject patient has not consumed cannabis on average more than three times a week in the past 30 days. Mild alcohol use disorder is also allowed.\n11. Patient has participated in another clinical trial in which they received an experimental or investigational drug or agent within 3 months before Visit 0. Patients who have participated in Type A studies (e.g. trials of standard and within-label treatments including antipsychotic medication) or non CTIMP studies (e.g. studies of exercise therapy) must have completed the intervention but may be included if permitted by the protocol of the other trial.\n12. The participant refuses any mandatory safety checks during the trial, specifically, refusal of: urine pregnancy test (those of child-bearing potential only); safety blood test; reporting of adverse events; and assessment of suicidality.\n13. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.\n\n    * Adequate doses are provided in Appendix B. \\*\\*Minor neurological disorders such as migraine, other minor headache disorders, sleep disorders or nerve palsies which are unlikely to affect study outcomes including neuroimaging measures are permitted.\n\n      * The decision to include the patient is at clinician's discretion. The clinician can conclude that it is safe for the patient to participate after the patient is evaluated, in which case this exclusion criterion does not apply and the patient can participate. Either way, the treating clinician needs to record his\u002Fher evaluation of suicidal risk in the source documentation or medical file, including his\u002Fher considerations, and notify the site PI of the decision.","40 Years",{"count":81,"type":22},250,[83],"PHASE3","The purpose of this study is:\n\n* To investigate whether the response to antipsychotic treatment can be enhanced by adding cannabidiol (CBD) to the existing treatment, compared to placebo, in participants with a first episode of psychosis, who have had a suboptimal or no response to their first antipsychotic treatment.\n* To confirm the safety of CBD in people with psychosis.\n\nThe study is a randomized, double-blind, placebo-controlled, multi-centre, clinical trial. Individuals with a diagnosis of first-episode psychosis, who have had a suboptimal or no response to their first antipsychotic treatment will be recruited. These participants are randomised to treatment with CBD oral solution 500mg twice daily, or a matching placebo for 6 weeks, as an adjunct to their existing antipsychotic treatment. By using a battery of clinical outcome assessments, the trial will also assess several biomarkers to determine if they can be used to predict clinical outcomes and response to treatment with CBD. Biomarkers are being assessed as an exploratory outcome measure. Participants will be invited to provide blood and stool samples, and may be asked to complete neuroimaging assessments at certain eligible sites.",[86,87,88,28],"Psychosis","First Episode Psychosis","Psychotic Disorders",[90,91],"Cannabidiol","first episode psychosis","NOT_YET_RECRUITING","2025-12-04",{"date":95,"type":38},"2025-12-12",{"date":97,"type":22},"2026-02",{"date":99,"type":22},"2029-02",{"name":101,"class":45},"University of Oxford",17,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":70},"100501761","impact-of-an-early-identification-program-for-first-episode-psychosis-on-the-duration-of-untreated-psychosis-100501761","NCT05813457","Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis","Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis. Multicenter, Randomized Stepped-wedge Study","PRESTO","Inclusion Criteria:\n\n* Patients with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or brief psychotic disorder established according to DMS 5\n* Never having taken neuroleptic treatment for antipsychotic purposes, except for the current episode and for a duration of \\\u003C 6 month\n* Oral consent of the patient or, for minors, of his\u002Fher parents to participate in the study\n\nExclusion Criteria:\n\n* Patients already treated and followed for FPE\n* Brief psychotic state not requiring specific management","15 Years","35 Years",{"count":114,"type":22},416,[25],"The First-Episode Psychosis (FPE) is a severe disorder that can include delusions, cognitive disorders and suicidal behavior. In the majority of cases (more than 80%) it evolves into schizophrenia. Numerous studies show that the rapidity of the initial management of FPE would reduce the risk of negative evolution and would have a decisive impact on the short and long term prognosis. The rapidity of this management can be measured by the duration of untreated psychosis, or DUP (Duration of Untreated Psychosis), the time interval between the appearance of the first frank psychotic symptoms and the initiation of adequate psychiatric care. The objective of this study is to show the impact of an intervention facilitating access to specialized care for PEP on the reduction of DUP. This intervention consists of an early identification program for FPE, the PRESTO program, specifically targeting 3 determining steps in the reduction of DUP:\n\n* Informing the general population about psychotic disorders\n* Knowledge of front line actors (APL: general practitioners, school and university medicine, teenager's house, associative networks educators, emergency services, firefighters, etc.) about FPE and its management\n* Articulation between APL and specialized psychiatric care",[28],[119,120,121,122],"Schizophrenia","Psychiatric centers","psychiatric illnesses","psychiatric care","2025-11-21",{"date":125,"type":38},"2025-11-24",{"date":127,"type":38},"2023-06-06",{"date":129,"type":22},"2027-04",{"name":131,"class":45},"Centre Hospitalier Universitaire de Saint Etienne"]