[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clinical-high-risk-for-psychosis-chr\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clinical-high-risk-for-psychosis-chr":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,70,99,122,146,166,198,221,249],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100585980","mobile-thinking-intervention-a-inital-test-100585980",false,"NCT06909422","Mobile Thinking Intervention: A Inital Test","A Mobile Intervention to Enhance Your Mood: A Test of the Acceptability and Efficacy","Inclusion Criteria:\n\n* Diagnosis of schizophrenia or related psychotic disorder OR\n* Identified as being at clinical high risk for psychosis in symptom interviews\n\nExclusion Criteria:\n\n* Recent changes in mental health treatment in past month or two months if on depot","ALL","18 Years","65 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study will test the inital efficacy of a brief mobile intervention targeting biased thinking.",[27,28],"Schizophrenia","Clinical High Risk for Psychosis (CHR)","NOT_YET_RECRUITING","2026-06-25",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":21},"2026-12",{"date":37,"type":21},"2028-12",{"name":39,"class":40},"University of Alabama at Birmingham","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100610385","phase-1-a-study-exploring-changes-in-a-variety-of-biomarkers-following-dosing-with-mt1988-in-participants-at-clinical-high-risk-for-psychosis-100610385","NCT07226895","A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis","A Study to Explore Changes in Cognitive, Clinical, Biological and Digital Measures Following 8 Weeks of Twice-daily Dosing of MT1988 and to Evaluate Safety & Tolerability of MT1988, in Participants at Clinical High Risk (CHR) for Psychosis","Inclusion Criteria:\n\n* Aged 17 to 30 years at time of consent.\n* Capacity to provide informed consent. (For patients under 17 years, participants must assent and informed consent provided by one parent or legal guardian).\n* Meet diagnostic criteria for Clinical High Risk of Psychosis (CHR).\n* For females of reproductive potential - not pregnant or nursing and willing to comply with contraceptive requirements.\n\nExclusion Criteria:\n\n* Clinically significant medical disorder or laboratory test abnormality at Day 1.\n* History of or current condition which may prevent participant from complying with study procedures.\n* Past or current schizophrenia, other disorder with symptoms of psychosis, major cognitive disorder resulting from traumatic brain injury.\n* Received antipsychotic medication equivalent to a total lifetime haloperidol dose \\>50 mg.\n* Current use of medications which could interfere with the study endpoints - to be assessed by the Investigator at screening.\n* Unable to abstain from nicotine (e.g. cigarettes, vape) for two hours before cognitive testing.\n* Unable to abstain from marijuana use on test day prior to test completion.\n* History of suicide attempt or behavior in previous 12 months, or risk of suicidal behavior during the study.","17 Years","30 Years",{"count":52,"type":21},150,[54,55],"PHASE1","PHASE2","The goal of this clinical trial is to learn how tests undertaken by people at high risk of developing psychosis (aged 17 to 30 years old) change when those people are given the study drug MT1988 daily for 8 weeks. This will help identify tests that could be used in later trials developing treatments for symptoms in people at high risk of developing psychosis, to measure whether those new treatments are effective.\n\nThe main question this trial aims to answer is:\n\nCan any of the tests (biomarkers) used in this study detect changes in participants dosed with one of two different dose levels of MT1988?\n\nResearchers will compare the results from two dose levels of MT1988 to a placebo group. Researchers do not expect to see the test results change in participants taking placebo and this will be compared to changes expected in test results in participants taking MT1988.\n\nParticipants will:\n\n* take a dose of MT1988 or placebo twice per day for 8 weeks\n* attend clinic appointments every two weeks to undertake assessments\n* report any side effects they experience to the researchers",[28],"RECRUITING","2026-06-04",{"date":61,"type":33},"2026-06-08",{"date":63,"type":33},"2026-03-03",{"date":65,"type":21},"2027-10",{"name":67,"class":68},"Monument Therapeutics Limited","INDUSTRY",15,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":49,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100566005","french-validation-of-schizophrenia-proneness-instrument--child-youth-100566005","NCT06649552","French Validation of Schizophrenia Proneness Instrument- Child Youth","SPI-CY-Fr","Inclusion Criteria :\n\n* Patients (men or women) followed at one of the 3 following structures in France : CLIP-Ado Nancy, CH Alpes-Isère, CHRU Lille for a suspected mental state at risk of developing psychosis, as determined by the CAARMS scale and\u002For the SPI-CY scale.\n* Age between 12 and 17 years and 11 months\n* Affiliation with a social security scheme or beneficiary of such a scheme.\n* Native language: French.\n* Adolescents who have been informed of the study, have received the study information note and have not objected to participating in the study\n* At least one of the holders of parental authority having been informed of the study, having received the relevant information note and not having objected to the adolescent participation\n* Consent to audio recording of the SPI-CY scale administration: for the adolescent and at least one parent.\n\nExclusion Criteria:\n\n* Pregnant woman, parturient or nursing mother\n* Person deprived of liberty by judicial or administrative decision\n* Person in a life-threatening emergency\n* Impairment of the subject that makes it difficult, if not impossible, to participate in the trial or to understand the information provided.\n* Abuse or dependence on any substance according to DSM V criteria, excluding cannabis","12 Years",{"count":79,"type":21},52,[24],"The clinical concept of a at risk mental state of developing psychosis is based on the identification of attenuated psychotic symptoms during the prodromal phase of psychoses (Schmidt et al., 2015). Early detection and support of these symptoms can delay the risk of transition to a first psychotic episode (van der Gaag, van den Berg, \\& Ising, 2019).\n\nThe Basic Symptom approach enables detection at the earliest stage of the prodromal phase. It postulates that subtle, subjective manifestations predating attenuated psychotic symptoms are present very early in the prodromal phase of psychosis and also have predictive value for the risk of developing psychosis (F. Schultze-Lutter, 2009). Basic symptoms are assessed using the Schizophrenia Proneness Instrument, available in an adult (SPI-A) and child\u002Fadolescent (SPI-CY) version. These scales are part of the international recommendations for the assessment of patients with a Clinical State at High Risk of Psychosis (CHR-P) (Schmidt et al., 2015; F Schultze-Lutter et al., 2015). The SPI-A is validated in French under the name \"Outil d'Evaluation du Risque Schizophrénique version adulte (OERS-A)\" (Schultze-Lutter et al., 2007. French translation by JR. Teyssier with the collaboration of F. Gamma and P. Loulergue), but no French version of the SPI-CY has yet been validated.\n\nIn collaboration with Dr. Frauke Schultze-Lutter, the investigators have recently published a French translation of the SPI-CY (Schizophrenia Predisposition Instrument - Version for Children and Adolescents, F. Schultze-Lutter, M. Marshall, E. Koch, 2021. French translation by F. Bernardin and C. Dondé). This French translation must now be validated to ensure the inter-rater fidelity of the interview.\n\nWe therefore propose to study the inter-rater reliability of the French version of the SPI-CY by comparing ratings between clinicians who have undergone training in basic symptoms and in administering the SPI-A and SPI-CY tools by Dr. Schultze-Lutter. This validation will be carried out by comparing, on the one hand, the rating of the SPI-CY by a clinician A who has administered it to the patient and, on the other hand, the blind rating of a clinician B on the basis of the interview recorded by clinician A with his patient.\n\nThe investigators will also explore the links between the SPI-CY and other clinical scales such as the Multisensory Hallucination SCale (MHASC) (Demeulemeester et al., 2015), the Prodromal Questionnaire 16 (PQ-16) (Lejuste et al., 2021), the Audiograph (Giersch, Huard, Park, \\& Rosen, 2021) and the Perceptual and Cognitive Aberrations (PCA) (McDonald et al., 2019).",[28],[84,85,86,87,88],"SPI-CY","Basic Symptoms","Psychosis","Clinical High Risk","Ultra High Risk","2026-04-21",{"date":91,"type":33},"2026-04-24",{"date":93,"type":33},"2025-02-13",{"date":95,"type":21},"2027-02-01",{"name":97,"class":40},"Centre Psychothérapique de Nancy",3,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100591198","phase-1-a-multimodal-imaging-study-of-dopamine-in-early-psychosis-100591198","NCT06977308","A Multimodal Imaging Study of Dopamine in Early Psychosis","MISDEP","Inclusion Criteria:\n\n1. Males or females between 18 and 30 years old\n2. Capacity to give informed consent\n3. Clinical High Risk (i.e., APSS, GRDS, BIPS)\n4. Antipsychotic free for 3 weeks before the PET scan\n5. Clinically stable enough for the study\n\nExclusion Criteria:\n\n1. Any substance use disorder, of any severity, within the previous month (before PET scan; not including nicotine or caffeine)\n2. Any current use of substance of abuse besides THC\u002Fmarijuana\u002Fcannabis\u002Fnicotine\u002Fcaffeine (on day of PET only)\n3. Daily tobacco use\n4. Pregnancy\n5. Lactation\n6. Presence of insulin-dependent diabetes\n7. IQ \\\u003C 70 (i.e., WTAR \\\u003C 6)\n8. Acute risk for suicide (i.e., score of 4-5 within the previous month or 6 within the previous 3 months on the CSSRS) or violence, or history of severe violent behavior that may be exacerbated by methylphenidate\n9. Presence of metallic objects in the body\n10. Lifetime exposure to radiation in the workplace (i.e., being badged for radiation exposure), or exposure to radiation in the context of research protocol within the previous year that exceeds annual limits\n11. More than one risk factor for coronary artery disease (e.g., smoking, hyperlipidemia, sedentary lifestyle)\n12. Hypertension\n13. Presence of clinically significant brain abnormalities. \\[For PET Scan Only\\]\n14. Previous adverse reaction to stimulants that would preclude receiving methylphenidate\n15. Presence or positive history of any cardiovascular disease, medical or neurological condition that would preclude methylphenidate administration or participation in this study\n16. A history of bipolar disorder Type 1, or any history of syndromal psychosis\n17. Lack of effective birth control",{"count":107,"type":21},115,[54],"The development of new treatments for psychosis, a psychiatric condition that is prevalent and highly disabling despite antipsychotic medications, has been limited, in part, by a lack of information from brain imaging studies during the period that leads to the development of psychotic symptoms. In this project the investigators will use Positron Emission Tomography (PET) and neuromelanin-sensitive magnetic resonance imaging (NM-MRI) to examine a brain chemical that is involved in schizophrenia called dopamine and where it first becomes abnormal. The investigators will use multimodal PET\u002FMR imaging (i.e., \\[11C\\]raclopride w\u002FMPH challenge and NM-MRI) in the same CHR patients. The investigators will recruit 115 clinical high risk individuals. All subjects will undergo \\[11C\\]raclopride w\u002Fmethylphenidate challenge and neuromelanin-MRI imaging along with clinical assessments. Patients will be followed every 3 months for two years or until conversion to psychosis, whichever comes first, to assess for conversion to psychosis and clinical outcomes.",[28],[112],"clinical high risk for psychosis","2026-04-06",{"date":115,"type":33},"2026-04-08",{"date":117,"type":21},"2026-06-01",{"date":119,"type":21},"2030-10-01",{"name":121,"class":40},"New York State Psychiatric Institute",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":129,"maxAge":50,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100631381","experience-of-uhr-and-pep-individuals-during-mindfulness-a-qualitative-phenomenological-study-100631381","NCT07499934","Experience of UHR and PEP Individuals During Mindfulness: a Qualitative Phenomenological Study","EMIP","Inclusion Criteria:\n\n* People aged between 15 and 30 years who meet the criteria for UHR or PEP status on the CAARMS scale and have a social functional impact (SOFAS score less than 50 or a decrease of more than 30% in the score)\n\nExclusion Criteria:\n\n* \\- Previous episode of schizophrenia, schizoaffective disorder, or bipolar disorder\n* Previous antipsychotic treatment for more than 12 months\n* Organic mental disorder or intellectual disability\n* Serious suicide\u002Fhomicidal risk (but admissible if this risk has been resolved)\n* Insufficient French language skills\n* Adult unable to give consent and not under legal guardianship\n* Protective measure (guardianship\u002Fconservatorship\u002Fjudicial protection) or under judicial supervision\n* Person deprived of liberty by judicial or administrative decision (including actual involuntary hospitalization)\n* Persons in a life-threatening emergency\n* Not affiliated with a social security scheme\n* Minors without parental authorization\n* Person who refused the audio recording of the interview","15 Years",{"count":131,"type":21},20,[24],"The goal of this qualitative study is to explore and describe the lived experiences of individuals at ultra-high risk (UHR) or first episode of psychosis (FEP) who have participated in a group-based mindfulness-based intervention. Secondary objectives include identifying potential adverse effects of a group-based mindfulness-based intervention among UHR or FEP.",[28],[86,136],"mindfulness","2026-03-24",{"date":139,"type":33},"2026-03-30",{"date":141,"type":33},"2026-01-19",{"date":143,"type":21},"2027-07-19",{"name":97,"class":40},2,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":145},"100582975","efficacy-of-mindfulness-in-preventing-progression-to-psychosis-in-individuals-with-an-ultra-high-risk-for-psychosis-100582975","NCT06870305","Efficacy of Mindfulness in PREventing Progression to Psychosis in Individuals With an Ultra High Risk for Psychosis","EM-PREPS","Inclusion Criteria:\n\n* People aged between 18 and 30 validating the criteria for UHR or PEP status on the CAARMS scale and having a social functional impact (SOFAS score below 50 or a reduction of more than 30% in the score)\n\nExclusion Criteria:\n\n* Previous episode of schizophrenic disorder, schizoaffective disorder or bipolar disorder\n* Previous antipsychotic treatment for more than 12 months\n* Organic mental disorder or intellectual disability\n* Serious suicidal\u002Fhomicidal risk (but admissible if this risk has been resolved)\n* Insufficient French language skills\n* Adult incapable of giving consent and not under legal protection\n* Protection measure (guardianship\u002Fcuratorship\u002Fcourt supervision) or under court supervision\n* Person deprived of liberty by judicial or administrative decision (including forced hospitalisation)\n* Persons in a life-threatening emergency\n* Not affiliated to a social security regime",{"count":154,"type":21},270,[24],"The main objective is to evaluate the efficacy of a group-based mindfulness therapy programme in reducing distress associated with symptoms of UHR (Ultra High Risk) or FEP (first psychotic episode) compared with usual treatment. The secondary objectives were to study the efficacy of a group-based mindfulness intervention: on the reduction of psychotic symptoms; on the maintenance over time (6 months of follow-up) of the efficacy of the intervention on the distress associated with the symptoms of the UHR or PEP state; and on various dimensions associated with care: cognitive functions, anxiety, quality of life.",[28],[86,136],{"date":160,"type":33},"2026-03-25",{"date":162,"type":21},"2029-04",{"date":164,"type":21},"2029-12",{"name":97,"class":40},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":174,"sex":16,"minAge":77,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100626387","phase-3-stratification-and-treatment-in-early-psychosis-study---promote-100626387","NCT07434973","Stratification and Treatment in Early Psychosis Study - PROMOTE","ImPRoving OutcoMes in Individuals at Clinical High Risk fOr Psychosis Using Cannabidiol: a Double-blind, Randomised conTrollEd Trial","STEP-PROMOTE","CHR-P patients:\n\nInclusion Criteria\n\n1. 12 to 35 years of age inclusive, willing and able to provide written informed consent\u002Fassent.\n2. Meet criteria for either the Attenuated Psychotic Symptoms (APS) or Brief Limited Intermittent Psychotic Symptoms (BLIPS) subgroups of the CHR-P state, defined using the CAARMS (PSYSCAN version), which also integrates the SIPS criteria. Inter-rater reliability will be ensured throughout via an ongoing training programme for the researchers at each site.\n3. The participant is currently not participating and is not expecting to start participation during the current trial in another intervention trial (e.g. medication, medical device, psychological intervention).\n4. Participants of childbearing potential\\* must be willing to ensure that they use highly effective contraception during the trial as per the requirements in the protocol\\*\\*\n5. For participants who take part in the optional MRI scans: they must be eligible for MRI scanning as per local requirements, for example concerning implants or braces.\n6. For participants who take part in optional CSF collection: they must be aged 18 years or over, have excluded intracranial hypertension through MRI, be within the reference ranges in coagulation tests, have a BMI ≤32kg\u002Fm2, and have no medical or surgical conditions in which a lumbar puncture is contraindicated.\n\nThe age range for eligibility has been applied as this corresponds to the usual age range for a clinical high-risk state; individual cases outside of this age range may have a different aetiology and\u002For prognosis which could impact on the trial outcomes.\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. There is no special requirement for male participants to use highly effective contraception as there are no known safety concerns in males, such as sperm toxicity, as per the investigator's brochure. This trial will also not be collecting male participant partner pregnancy data.\n\n\\*A person is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal 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 trial and for 3 months after any trial drug administration, unless surgically sterile or postmenopausal (no menses for 12 months without an alternative medical cause).\n\nExclusion Criteria\n\n1. Previous neurosurgery or neurological disorder, including epilepsy, which may affect the trial procedures;\\*\n2. Pregnancy or breastfeeding;\n3. The participant is unable to fully comprehend the purpose of the trial or make a rational decision whether or not to participate;\n4. IQ\\\u003C70 as measured by a validated IQ test e.g. WASI, WAIS, WISC, as approved for local languages and appropriate for the participant's age;\n5. Meeting DSM-5 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-5-RV) as long as the subject has not consumed cannabis on average more than three times a week in the past 30 days. Mild alcohol use disorder is also allowed;\n6. Antipsychotic exposure: any antipsychotic medication in the two weeks before screening at doses adequate for treating FEP (≥ minimum effective dose); or antipsychotic medication for longer than a cumulative total of 30 days in the 3 months before screening at doses adequate for treating FEP (≥ minimum effective dose);\\*\\*\n7. Any past episode of frank psychosis (excluding BLIPS);\n8. Hypersensitivity to the active substance, sesame oil, sesame seed, or any of the excipients listed in section 3.3 of the IB;\n9. Current treatment with valproate (including valproic acid, sodium valproate, valproate semisodium);\n10. Current treatment with clobazam;\n11. Known hepatic insufficiency and\u002For transaminase levels exceeding the upper limit 2 times or more and bilirubin greater than 1.5 times the upper limit of normal;\n12. Active suicidal ideation within the past 2 weeks (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 trial) or presence of risk (e.g. violence) \\*\\*\\*;\n13. The participant has participated in another research study in which the participant received an experimental or investigational drug or intervention within 3 months before Visit 0;\n14. The participant refuses or cannot do any mandatory safety checks during the trial, specifically, refusal of: pregnancy test (those of childbearing potential only); safety blood tests; reporting of adverse events; or assessment of suicidality;\n15. Those of childbearing potential not willing to use a highly effective form of contraception during participation in the trial. There is inadequate information on the effects of cannabidiol on the foetus. Participants of childbearing potential should use a highly effective method of contraception for the duration of the main trial and for 3 months after any administration of trial intervention;\n16. Traumatic brain injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument.\n\n    * Minor neurological disorders such as migraine, other minor headache disorders, sleep disorders or nerve palsies that are unlikely to affect trial or biomarker outcomes can be permitted.\n\n      * If at screening, a potential participant is prescribed an antipsychotic at a dose ≥ minimum effective dose for treating FEP, they may be re-screened for trial participation at a later date if the dose is subsequently reduced below threshold for at least 2 weeks. Any decision to do so will be the responsibility of the treating clinician and must ensure that it is both safe and ethical to do so. Specialist advice will be made available and be provided by clinicians experienced in managing CHR-P at University of Oxford and King's College London.\n\n        * The decision to include the patient is at the clinician's discretion. In case of a score of 1 or higher in CDSS question 8, 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.\n\nHealthy controls:\n\nInclusion Criteria\n\n1. 12 to 35 years old;\n2. Written informed consent\u002Fassent;\n3. Be assessed for the CHR-P state but do not meet CHR-P criteria: Attenuated Psychotic Symptoms (APS) or Brief Limited Intermittent Psychotic Symptoms (BLIPS) defined using the CAARMS;\n4. Be assessed with the SCID-5-RV and do not meet any diagnostic criteria of any Axis I psychiatric disorder.\n\nExclusion Criteria\n\n1. Lifetime history of a DSM Axis-I psychiatric disorder as determined by the SCID-5-RV;\n2. Lifetime history of meeting CHR-P state criteria;\n3. First-degree relative with a lifetime history of affective or non-affective psychosis (defined by treatment or diagnosis);\n4. Previous intake of antipsychotic medication at any dosage;\n5. Current intake of psychoactive medication;\n6. Previous neurosurgery or neurological disorder, including epilepsy, which may affect the trial procedures;\n7. Pregnant or breastfeeding;\n8. Participant is unable to fully comprehend the purpose of the trial or make a rational decision whether or not to participate;\n9. IQ\\\u003C70 as measured by a validated IQ test e.g. WASI, WAIS, WISC, as approved for local languages and appropriate for the participant's age;\n10. Any contraindications for MRI;\n11. Refusing to have their blood drawn and\u002For their MRI performed.",true,"35 Years",{"count":177,"type":21},586,[179],"PHASE3","The purpose of this trial is:\n\n* To investigate whether cannabidiol (CBD), compared to placebo, can reduce the severity of attenuated psychotic symptoms in individuals at clinical high risk for psychosis.\n* To confirm the safety of CBD in individuals at clinical high risk for psychosis.\n\nThe trial is a randomised, double-blind, placebo-controlled, multi-centre, international clinical trial. Individuals meeting clinical high risk for psychosis criteria will be recruited for the trial intervention component of the trial. Participants are randomised to treatment with oral CBD 300mg (oral solution 100 mg\u002FmL) twice daily, or a matching placebo, for 104 weeks. By using a battery of clinical outcome assessments, the trial will be able to assess several biomarkers to predict clinical outcomes and response to treatment with CBD. Participants will be invited to provide blood samples, stool samples, cerebrospinal fluid samples (if aged 18 years or over) and complete neuroimaging assessments. Individuals who are not found to have mental illness as defined by DSM-5 criteria will be recruited to a healthy control group, to validate the biomarker component of the trial.\n\nAdditionally, a control group of healthy volunteers will be recruited who will not take the trial intervention to aid calibration between datasets from sites acquiring MRI data and to inform and validate any possible multivariate signature associated with the CHR-P state, course or outcome by understanding how these measures are different in controls. Healthy controls will also be used for secondary case-control comparisons. Healthy controls will undergo clinical and biomarker assessments only.",[28,182,183],"Clinical High Risk for Psychosis","Clinical High Risk for Developing Psychosis",[172,185,186,182,187],"PROMOTE","CHR-P","psychosis","2026-02-19",{"date":190,"type":33},"2026-02-27",{"date":192,"type":21},"2026-05-01",{"date":194,"type":21},"2031-12-01",{"name":196,"class":40},"University of Oxford",19,{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":205,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":41},"100513675","telehealth-cognitive-behavioral-therapy-for-youth-at-risk-for-psychosis-100513675","NCT05968560","Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis","Telehealth Adaptation of Group and Family-Based Cognitive Behavioral Therapy for Youth at Risk for Psychosis","Inclusion criteria:\n\n* Age 14-25\n* Ability to participate in assessments and treatment in English\n* Meets criteria for psychosis-risk on SIPS\n* Stable on medications; no changes within 1 month prior to enrollment\n* Identification of one \"family member\" with \\>4 hours\u002Fweek contact who is willing to participate (\"Family member\" can be any blood relative, spouse, significant other, or close friend whom the subject identifies as a consistent and important person in their life).\n\nExclusion criteria:\n\n* Intellectual disability (IQ\\\u003C70)\n* Medical condition known to cause psychosis\n* Moderate or severe substance use disorder and active use within the past 30 days.","14 Years","25 Years",{"count":208,"type":21},72,[24],"This study aims to evaluate the feasibility and effectiveness of telehealth interventions for individuals at clinical high risk for psychosis (CHR). Psychosis typically emerges during late adolescence or early adulthood, significantly impacting long-term functioning. While CHR programs have the potential to reduce illness severity, individuals often face barriers such as stigma and limited access to services. Telehealth interventions could address these barriers and improve treatment accessibility and engagement. The study will focus on Group and Family-Based Cognitive Behavioral Therapy, Family-Based CBT, and individual CBT, adapted for telehealth delivery (GF-CBT-TH, F-CBT-TH, and I-CBT-TH). Participants aged 14-25 who meet CHR criteria will be randomly assigned to one of these interventions. Feasibility will be measured by recruitment rate, attendance, and retention. The study will assess the impact of the interventions on cognitive biases, social connectedness, family emotional climate, and proficiency in CBT skills. The three intervention groups will be compared in terms of psychosocial functioning, symptom severity, rates of remission from CHR, and rates of transition to psychosis. Additionally, factors like patient treatment preference, family emotional climate, and sociodemographic factors will be explored as potential moderators of treatment outcomes. Qualitative interviews will be conducted with participants and clinicians to inform dissemination efforts.",[28],"2026-01-16",{"date":214,"type":33},"2026-01-20",{"date":216,"type":33},"2023-07-21",{"date":218,"type":21},"2026-12-31",{"name":220,"class":40},"Icahn School of Medicine at Mount Sinai",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":205,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":41},"100560880","interventions-for-clinical-high-risk-youth-in-tunisia-100560880","NCT06582901","Interventions for Clinical High Risk Youth in Tunisia","Cognitive Training vs. Treatment as Usual to Improve Functioning and Reduce Transition Rates in Tunisian CHR Youth: A Feasibility Study","CHRTUNISIA","Inclusion Criteria:\n\n* Meets Comprehensive Assessment for At Risk Mental States (CAARMS) criteria for Clinical High Risk\n* If under the age of 18, the subject has a parent or guardian who can sign consent forms\n* Premorbid Intelligence Quotient not less than 70\n* Sufficient fluency in Arabic, French, or English to avoid invalidating research measures\n* Residence likely within commuting distance of Razi University Hospital\n\nExclusion Criteria:\n\n* Evidence of known neurological disorder, e.g. epilepsy or significant head injury that could account for the CHR symptoms\n* Evidence of significant and habitual alcohol or substance use in the 6 months prior to study entry\n* Evidence that the clinical high-risk symptoms were substance-induced","28 Years",{"count":231,"type":21},54,[24],"Study participants will take part in one of the two types of treatments aimed at improving daily functioning as follows: either a Cognitive Training (CT) Program or an Enhanced - Treatment as Usual (E-TAU) Group. All group treatments will be provided at Razi Hospital and one of the sessions will be conducted at home. The Cognitive (thinking skills) Training and Neuropsychological Education Approach to Remediation (CT-NEAR) is a form of cognitive (thinking skills) training that consists of computer-game like brain exercises, learning about thinking skills strategies, and a \"bridging group\" to help participants use what is learned in daily life. Cognitive exercises are generally fun and playful and are done on a computer. The aim is to train thinking skills and ability to function better in daily life such as at school, university, or at work, or with friends and family. The program lasts 12 weeks with two weekly sessions in groups of 3 to 4 participants. Each session is 1½ hours in length and one of the sessions is which lasts 30 minutes is conducted at home using a tablet that will be provided by the study investigators.",[28],[236,237,238,239],"clinical High Risk youth","cognitive training","enhanced treatment as usual","transition to psychosis","2025-11-21",{"date":242,"type":33},"2025-11-25",{"date":244,"type":33},"2023-09-01",{"date":246,"type":21},"2026-08-31",{"name":248,"class":40},"University of California, Los Angeles",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":256,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":263,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":41},"100587480","digital-dialectical-behavioural-therapy-d-dbt-for-youth-at-clinical-high-risk-chr-for-psychosis-100587480","NCT06928935","Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis","Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis: An Exploratory Multi-Methods Study","Inclusion Criteria:\n\n1. Be 16-29 years old.\n2. Being competent and willing to consent to study participation.\n3. Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS) within the past 3 years.\n\nExclusion Criteria:\n\n1. Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features)\n2. Diagnosis of intellectual disability\n3. Severe developmental disorder\n4. Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care).\n5. Receiving any additional psychotherapy interventions or structured digital mental health support during the study period.","16 Years","29 Years",{"count":259,"type":21},60,[24],"This study examines the feasibility and acceptability of a digital dialectical behavior therapy (d-DBT) intervention for youth at clinical high risk (CHR) for psychosis. The study aims to assess the acceptability of the intervention to the CHR population, the feasibility of conducting a larger-scale clinical efficacy trial and the potential benefits in improving emotional regulation, reducing psychiatric symptoms, and enhancing overall functioning. Participants will be randomized to receive either the d-DBT intervention or treatment as usual over eight weeks.",[28],[264,265,266,267,268,112],"digital therapy","dialectical behavioural therapy","emotional dysregulation","mental health intervention","digital mental health","2025-04-08",{"date":271,"type":33},"2025-04-15",{"date":273,"type":21},"2025-04-28",{"date":275,"type":21},"2028-01-01",{"name":277,"class":40},"Centre for Addiction and Mental Health"]