[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"first-episode-psychosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:first-episode-psychosis":324},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,43,87,113,143,159,183,214,243,267,289,307],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100575602","digital-strategies-to-advance-help-seeking---aim-3-100575602",false,"NCT06774417","Digital Strategies to Advance Help-Seeking - Aim 3","Digital Strategies to Advance Help-Seeking in Youth at Clinical High Risk for Developing Psychosis","Inclusion Criteria:\n\n* Ages 12-29 years\n* Living within a 50-mile radius of a US based AMP-SCZ site\n* Able to complete the English language PQ-B on MHA's screening platform","ALL","12 Years","29 Years",{"count":20,"type":21},25000,"ESTIMATED","INTERVENTIONAL",[24],"NA","This proposal aims to establish a Digital Laboratory focused on advancing help-seeking and expediting treatment initiation in youth ages 12-29 who are at Clinical High-Risk (CHR) for developing psychosis. Leveraging the Health Action Process Approach (HAPA) model, this study will identify help-seeking subtypes in 25,000 youth who screen positive for psychosis-risk on Mental Health America's national online screening platform, iteratively develop and test theory and data-driven, personalized strategies to advance help-seeking using Micro-Randomized Trials and a Sequential Multiple Assignment Randomized Trial, identify the most accurate CHR screening threshold in an online environment, and link youth, when indicated, to local clinical care via AMP-SCZ, a NIH funded national network of CHR programs throughout the US. This academic-industry partnership aims to curate one of the largest datasets of youth with CHR, and to develop effective strategies to enhance early help-seeking, in a population where help-seeking is critical and a significant barrier to care.",[27,28,29],"Clinical High Risk","Early Psychosis","First Episode Psychosis","RECRUITING","2026-06-16",{"date":33,"type":34},"2026-06-18","ACTUAL",{"date":36,"type":34},"2026-02-02",{"date":38,"type":21},"2028-05-31",{"name":40,"class":41},"Columbia University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":65,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100642980","feel-good-a-multicenter-trial-of-a-mindfulness-based-group-therapy-in-young-adults-with-early-psychosis-100642980","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","16 Years","35 Years",{"count":54,"type":21},252,[24],"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).",[58,59,60,61,62,63,64],"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)",[66,67,68,69,70,71,72,73,74,62,75,76],"Randomized controlled trial","Emotion regulation","Ecological momentary assessment","Early psychosis","First-episode psychosis","Mindfulness-based intervention","PANSS","EMA","Schizophrenia spectrum disorder","Mindfulness","observer-rated","2026-06-09",{"date":79,"type":34},"2026-06-12",{"date":81,"type":34},"2026-05-27",{"date":83,"type":21},"2028-12-31",{"name":85,"class":41},"Stephanie Mehl",8,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100468792","biomarkers-predictive-of-thymic-evolution-and-therapeutic-response-at-2-years-in-patients-with-a-first-psychotic-episode-100468792","NCT05384392","Biomarkers Predictive of Thymic Evolution and Therapeutic Response at 2 Years in Patients With a First Psychotic Episode","PEPAMARKER","Inclusion Criteria:\n\n* Patient with a first episode of psychosis,\n* Aged between 15 and 30 years,\n* Able to consent and having signed a consent form (parental consent for minors).\n\nExclusion Criteria:\n\n* Introduction or increase of antipsychotic and\u002For antidepressant and\u002For thymoregulatory treatment in the last month,\n* Mother tongue other than French,\n* Psychotic episode due to an organic disorder,\n* Psychotic episode induced by the use or withdrawal of toxic substances with severe dependence ,\n* Intellectual deficit,\n* Chronic inflammatory disease,\n* Immunomodulatory treatment,\n* Contraindication to MRI,\n* Pregnant or breastfeeding woman,\n* Patient under court protection, guardianship, curatorship or deprived of liberty.","15 Years","30 Years",{"count":97,"type":21},217,[24],"Psychosis is a severe, common, and disabling psychological disorder. An epidemiological study conducted in England reported an incidence of 34 new cases per 100,000 person-years, with a peak between 16 and 19 years of age. Following a first psychotic episode, two clinical evolutions are possible: thymic psychosis (17%) and non thymic psychosis (83%). The first includes bipolar disorders with a psychotic component and major depressive disorders with a psychotic component; the second, other psychotic disorders, mainly schizophrenia. One of the major difficulties encountered is the frequent impossibility of specifying the type of psychosis at the beginning of the psychotic episode. However, these disorders require different therapies, particularly medication. This leads to a delay in diagnosis with a high risk of relapse.\n\nThe semiological study of these diseases being carried out within the framework of interviews, it seems interesting to be able to record these and to obtain a quantitative and objective measurement through the study of language. The use of machine learning has made it possible to distinguish patients with schizophrenia from those with bipolar disorder by graphical analysis of language in a more efficient way than with clinical scales.Moreover, it is possible to identify linguistic markers: thus, an alteration of syntactic structures and prosody would be more present in non-thymic than in thymic psychoses.\n\nParaclinical markers are also emerging. In particular, the link between inflammation and mental disorders.For example, an increase in IL-8 has been found only in thymic psychoses.\n\nIn this context, it seems essential to be able to distinguish these disorders as early as possible through the combined use of clinical and paraclinical markers, and to be able to better understand their pathophysiology.",[60],[102,103],"Bipolar Disorder","Schizophrenia",{"date":105,"type":34},"2026-06-11",{"date":107,"type":34},"2025-03-27",{"date":109,"type":21},"2030-03",{"name":111,"class":41},"University Hospital, Brest",5,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":52,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":42},"100602363","recovery-with-exogenous-ketones-and-antipsychotics-100602363","NCT07122531","Recovery With Exogenous Ketones and Antipsychotics","Metabolic and Clinical Evaluation of Medium-Chain Triglyceride-Based Exogenous Ketone Supplementation as an Adjunctive Treatment for First-Episode Psychosis","RECAP","Inclusion Criteria:\n\n* Referred or self-referred to the PEP Clinic of the Estrie region, either as an outpatient or inpatient.\n* Currently receiving a second- or third-generation antipsychotic at a stable dose for at least 4 weeks.\n* Able to read and communicate in French or English.\n* Capable of understanding and signing the informed consent form.\n\nExclusion Criteria:\n\n* Pregnancy, childbirth within the past 6 months, or breastfeeding.\n* any use of MCT oil, ketone salts, or a ketogenic diet within the past year.\n* Previous diagnosis of type I or type II diabetes.\n* Uncontrolled acute suicidal ideation at the time of inclusion in the PEP clinic.\n* Other conditions that may interfere with participation, as determined by the qualified physician.\n* Pancreatitis (inflammation of the pancreas) or liver failure.\n* Metabolic condition affecting fat metabolism or inherited carnitine deficiency and its related enzymes.\n* Porphyria.\n* Pyruvate kinase deficiency.\n* Neurodevelopmental disorder of unknown etiology or rare genetic disease.","18 Years",{"count":123,"type":21},15,[24],"The RECAP project will evaluate the clinical and metabolic effects of adding exogenous ketones to antipsychotic (AP) treatment in young adults with a first episode of psychosis (FEP).\n\nFEP requires early intervention to limit relapse, chronic symptoms, cognitive decline, and reduced life expectancy. Symptoms include positive (hallucinations, delusions), negative (amotivation, anhedonia), cognitive (attention, working memory), and mood disturbances. Standard care combines second- or third-generation APs with psychosocial interventions. However, many patients have persistent symptoms despite optimal treatment.\n\nPsychosis is linked to increased cardiovascular and obesity risk. APs can cause insulin resistance, type 2 diabetes, and dyslipidemia, but some metabolic abnormalities-both systemic and cerebral-may precede AP use, suggesting an intrinsic metabolic dysfunction. Brain energy metabolism is often impaired, with altered insulin signaling, glucose transport, and ATP production. Glucose hypometabolism in the prefrontal cortex correlates with negative and cognitive symptoms, even before medication, resembling patterns in Alzheimer's, bipolar disorder, and depression.\n\nKetones, especially beta-hydroxybutyrate, provide an alternative to glucose for brain energy. Ketogenic diets have therapeutic potential but are difficult to maintain, particularly in psychiatric populations. Exogenous ketones, such as medium-chain triglycerides (MCTs), can raise circulating ketone levels without major dietary changes. MCT supplementation has been shown to improve brain metabolism and cognition in other conditions, but no studies have tested it in FEP.\n\nThis uncontrolled, prospective pilot study will provide 15 g of MCT oil twice daily for 12 weeks, in addition to participants' usual diet and treatment. The primary objective is to assess changes in circulating ketone levels and metabolic markers (glucose, insulin, HbA1c). Secondary objectives include feasibility, acceptability, effects on real-time glucose metabolism (via continuous glucose monitoring), clinical symptoms (negative, cognitive), quality of life, other metabolic biomarkers, and general systemic markers.\n\nThis is the first study to test exogenous ketones in FEP. It will assess safety, tolerability, and potential metabolic and clinical benefits, offering preliminary mechanistic insights and guiding future integrative mental health strategies.",[29],[128,103,129,130,131,132,133],"first episode psychosis","metabolism","ketone","medium triglyceride","antipsychosis","glucose","2026-05-19",{"date":136,"type":34},"2026-05-22",{"date":138,"type":34},"2025-08-26",{"date":140,"type":21},"2027-08-15",{"name":142,"class":41},"Université de Sherbrooke",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":148,"targetDuration":4,"studyType":149,"phases":4,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":158,"locationsCount":42},"100575603","digital-strategies-to-advance-help-seeking-aim-1-and-2-100575603","NCT06774430","Digital Strategies to Advance Help-Seeking Aim 1 and 2",{"count":20,"type":21},"OBSERVATIONAL","This proposal aims to establish a Digital Laboratory focused on advancing help-seeking and expediting treatment initiation in youth ages 12-29 who are at Clinical High-Risk (CHR) for developing psychosis. Leveraging the Health Action Process Approach (HAPA) model, this study will identify help-seeking subtypes in 25,000 youth who screen positive for psychosis-risk on Mental Health America's national online screening platform, iteratively develop and test theory and data-driven, personalized strategies to advance help-seeking using Micro-Randomized Trials and a Sequential Multiple Assignment Randomized Trial, identify the most accurate CHR screening threshold in an online environment, and link youth, when indicated, to local clinical care via Accelerating Medicines Partnership - Schizophrenia (AMP-SCZ), a NIH funded national network of CHR programs throughout the US. This academic-industry partnership aims to curate one of the largest datasets of youth with CHR, and to develop effective strategies to enhance early help-seeking, in a population where help-seeking is critical and a significant barrier to care.",[27,28,29],"2026-04-30",{"date":154,"type":34},"2026-05-05",{"date":156,"type":34},"2025-04-07",{"date":38,"type":21},{"name":40,"class":41},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":52,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":42},"100390753","normobaric-oxygen-therapy-for-individuals-with-first-episode-psychosis-100390753","NCT04368039","Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis","* Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5.\n* Less than 5 years since the onset of frank psychotic symptoms as determined using the Symptom Onset in Schizophrenia Inventory .\n* No evidence of a pre-existing intellectual disability defined as a premorbid IQ \\>70 as estimated using the Reading subtest of the Wide Range Achievement Test-4.\n* Ages 15-35\n* Non-smoker for past six months\n* Absence of suicidal ideation or behavior over the past month as assessed by the Columbia Suicide Severity Rating Scale\n* The American Association for Respiratory Care notes that \"no absolute contraindications to oxygen therapy exist when indications \\[for oxygen therapy\\] are present.\"",{"count":166,"type":21},20,[24],"Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.",[62,103,60],[171,172,173],"psychosis","treatment","normobaric hyperoxia","2026-02-23",{"date":176,"type":34},"2026-02-25",{"date":178,"type":34},"2019-12-04",{"date":180,"type":21},"2026-12-07",{"name":182,"class":41},"Nicholas Breitborde",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":191,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":204,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":4},"100622752","phase-1-on-track-for-wellness-otw-stepped-wedge-cluster-randomized-trial-100622752","NCT07387705","On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial","On Track for Wellness: Stepped-wedge Cluster Randomized Trial of a Fitbit Enhanced Health Intervention for Early Onset Psychosis","OTW","Inclusion Criteria: client at First Episode psychosis program -\n\nExclusion Criteria: not a client at a First Episode psychosis program\n\n\\-",true,{"count":193,"type":21},365,[195],"PHASE1","This study will evaluate a program called On Track for Wellness (OTW) which is being adopted by the Illinois Department of Human Services' Division of Behavioral Health \\& Recovery (DBHR) for use in all state-funded early psychosis programs in Illinois. OTW combines use of Fitbit activity trackers with health education, goal setting to promote health activation, and ongoing support for maintaining healthy lifestyles. Successful completion of this research will gauge the effectiveness of this program in improving sleep hygiene and increasing physical activity among people recently diagnosed with schizophrenia or other psychotic disorders.",[198,199,29],"Sleep","Physical Activity",[201,202,203],"sleep","physical activity","first episode psychosis treatment","NOT_YET_RECRUITING","2026-01-29",{"date":207,"type":34},"2026-02-04",{"date":209,"type":21},"2026-06-01",{"date":211,"type":21},"2030-12-01",{"name":213,"class":41},"University of Illinois at Chicago",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":227,"conditions":228,"keywords":231,"overallStatus":204,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"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":224,"type":21},250,[226],"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.",[62,29,229,230],"Psychotic Disorders","Psychotic Episode",[232,128],"Cannabidiol","2025-12-04",{"date":235,"type":34},"2025-12-12",{"date":237,"type":21},"2026-02",{"date":239,"type":21},"2029-02",{"name":241,"class":41},"University of Oxford",17,{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":42},"100430809","pilot-rct-of-self-stigma-treatment-for-first-episode-psychosis-100430809","NCT04889911","Pilot RCT of Self-stigma Treatment for First Episode Psychosis","Development of a Stage-specific Adaptation of a Self-stigma Intervention for People Recovering from a First Episode of Psychosis","NECT-YA","Inclusion Criteria:\n\n1. Meets criteria for FEP youth based on the following definition: age 15-24, onset of psychotic symptoms within the last 5 years, and an absence of a primary substance use or mood disorder that could be causing the psychotic symptoms (confirmed by program eligibility);\n2. Meets criteria for moderate (defined as a mean score of 1-1.5 on the 0-3 scale of the Internalized Stigma of Mental lllness Scale \\[ISMI\\]) or elevated (defined as a mean score of 1.5-3 on the 0-3 scale of the ISMI) self-stigma;\n3. Speaks English well enough to complete assessments and participate in groups;\n4. Is able to provide informed consent to participate.\n\nExclusion Criteria:\n\nDoes not meet any of the above inclusion criteria.","24 Years",{"count":253,"type":21},40,[24],"The overall purpose of the proposed exploratory intervention development application, is to conduct research that will inform the adaptation and preliminary testing of NECT modified for youth (aged 15-24) with first episode psychosis (FEP), targeting self-concept and illness conceptions to increase treatment engagement. The specific aims of the project are to: 1) adapt NECT to be responsive to the needs and preferences of youth with FEP, and 2) Assess the feasibility, acceptability and preliminary effectiveness of the modified intervention (NECT-YA) combined with coordinated specialty care (CSC) services, compared to CSC services alone, in a small (n = 40) RCT.",[29,257],"Youth","2025-03-19",{"date":260,"type":34},"2025-03-24",{"date":262,"type":34},"2023-08-01",{"date":264,"type":21},"2025-08",{"name":266,"class":41},"John Jay College of Criminal Justice, City University of New York",{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":222,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":276,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":112},"100366071","phase-4-artificial-intelligence-to-measure-adherence-to-oral-medication-100366071","NCT04046497","Artificial Intelligence to Measure Adherence to Oral Medication","Early-phase Schizophrenia: Practice-based Research to Improve Outcomes (ESPRITO) - Using Artificial Intelligence to Measure Adherence to Oral Medication","Inclusion Criteria:\n\n* Enrolled in a CSC program\n* Prescribed an oral antipsychotic\n\nExclusion Criteria:\n\n* none",{"count":275,"type":21},200,[277],"PHASE4","The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients with first episode psychosis.",[29],"2024-09-10",{"date":282,"type":34},"2024-09-19",{"date":284,"type":34},"2020-11-20",{"date":286,"type":21},"2024-12-31",{"name":288,"class":41},"Northwell Health",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":191,"sex":16,"minAge":94,"maxAge":222,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},"100362913","phase-4-disengagement-in-csc-identifying-those-at-risk-and-addressing-their-needs-100362913","NCT04005378","Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs","Inclusion Criteria:\n\n* Enrolled into a CSC program\n\nExclusion Criteria:\n\n* None",{"count":296,"type":21},300,[277],"Maintaining treatment engagement is critical for first episode psychosis patients to experience gains possible with coordinated specialty care (CSC). This study is designed to identify CSC participants still receiving care but at high risk for disengagement and to intervene to prevent\u002Fdelay disengagement.",[29],{"date":282,"type":34},{"date":302,"type":34},"2020-07-01",{"date":304,"type":21},"2024-11-30",{"name":288,"class":41},3,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":222,"enrollmentInfo":314,"targetDuration":4,"studyType":149,"phases":4,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":42},"100362835","early-phase-schizophrenia-practice-based-research-to-improve-outcomes-100362835","NCT04004364","Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes","ESPRITO","Inclusion Criteria:\n\n* Enrolled in CSC program\n\nExclusion Criteria:\n\n* none",{"count":315,"type":21},700,"The goal if the project is to develop a learning health network devoted to the treatment of first episode psychosis.",[29],{"date":282,"type":34},{"date":320,"type":34},"2020-04-01",{"date":322,"type":21},"2025-03-31",{"name":288,"class":41},"First-Episode Psychosis"]