[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychosis-nos\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychosis-nos":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100613164","phase-3-cognitive-strategies-in-early-psychosis-2-100613164",false,"NCT07263022","Cognitive Strategies in Early Psychosis 2","COSTEP 2","Inclusion Criteria:\n\n* Between the ages of 18 and 35\n* Onset of a psychosis spectrum illness (schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis) within 5 years of enrollment\n* Estimated IQ of 70 or above\n* Proficient at English as determined through interactions with the study team\n* No change in psychiatric medication within a week of enrollment or MRI study visits\n* No clinically significant change in any medications for at least 1 month prior to study participation or MRI study visits, as determined by PI\u002FCo-Is\n\n  * Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have had major increases or decreases in doses, or additions or removal of medication within the past 30 days.\n  * Participants are to have no changes to medications in the past 7 days before drug administration (i.e., must have been on a stable dose for at least 7 days prior to receiving the study drug).\n\nExclusion Criteria:\n\nMedical Criteria:\n\n* Presence of the following medical concerns as determined by the study PI:\n\n  * Major neurological disorder\n  * History of a clinically significant head injury with or without prolonged unconsciousness\n  * Any major medical condition that, in the opinion of the PI, would impede participation in the study or would put the participant at additional risk by participating\n* History of any of the following as reported by the participant:\n\n  * Renal impairment, injury, or disease\n  * Hepatic impairment, injury, or disease\n  * Myocardial infarction or heart disease, or endorsement of history of or of cardiac symptoms at intake:\n\n    * Dyspnea\n    * Palpitations\n    * Orthopnea\n    * Pedal oedema\n    * Significant dizziness\n    * Syncope\n    * Claudication\n  * Low white blood cell count, or is diagnosed with leukopenia, neutropenia, or agranulocytosis\n* Presence of unmanaged hypertension (\\>140\u002F90) or elevated resting heart rate (\\>100 bpm)\n* Abnormal clinical laboratory values:\n\n  * uACR \\> 30 mg\u002Fg\n  * creatinine level \\>0.95 mg\u002FdL\n  * AST or ALT \\> 50 U\u002FL\n  * Bilirubin \\> 1.2 mg\u002FdL\n  * Total Protein \\\u003C 6 g\u002FdL\n* Taking a medication or supplement that has a major drug interaction with any study drugs (e.g., ketamine, MAOIs, clomipramine, diazepam, propranolol, warfarin)\n* Allergies to study drugs\n* Is pregnant, planning to become pregnant, or is breastfeeding\n* Cannot pass the visual acuity test\n* Cannot pass the CMRR Subject Safety Screen due to MRI contraindications\n\nMental health criteria:\n\n* Meets criteria for a severe substance or alcohol use disorder within 3 months of enrollment\n* Lifetime history of a stimulant use disorder\n* Current manic episode as determined by the MINI\n* History of psychiatric hospitalization within 3 months of enrollment\n* Meets criteria for clinical risk of suicidal behavior, as defined by:\n\n  * Clinician judgment\n  * A suicide attempt within 3 months of enrollment\n  * Active suicidal ideation at screening or baseline, as indicated by the C-SSRS Screener\n  * Previous intent to act on suicidal ideation with a specific plan and\u002For preparatory acts within 3 months of enrollment, as indicated by the C-SSRS Screener\n* Symptom severity scores in the severe (6) or extremely severe (7) range on the BPRS for the following items: suicidality, disorientation, bizarre behavior, excitement, elevated mood\n* Any other psychiatric symptoms or conditions that, in the opinion of the PI, would impede participation in the study or put the participant at additional risk by participating\n\nOther criteria:\n\n* Unable or unwilling to provide informed consent\n* Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study\n* Current guardianship\n* Is under civil commitment or under a stay of civil commitment\n* Illiteracy\n* Has engaged in significant cognitive training, in the opinion of the PI, in the last year","ALL","18 Years","35 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this clinical trial is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. Participants will be people who have had symptoms of a psychosis spectrum disorder start within the last five years. The investigators will study how two study agents change decision making in people with psychosis, by asking participants to complete some brain games on the computer before and after taking the study agents. The investigators hope to improve our understanding of psychosis to help people in the future. The main research questions are:\n\n* Does a single dose of modafinil change how people with psychosis play the brain games?\n* Does a single dose of d-serine change how people with psychosis play the brain games?\n* Does a single dose of modafinil change brain activity?\n* Does a single dose of d-serine change brain activity?\n\nParticipants will:\n\n* Complete an interview and self-report questionnaires.\n* Complete safety screening activities, like a blood draw, a urine drug test, and an alcohol breathalyzer test.\n* Complete functional Magnetic Resonance Imaging (fMRI) scans. fMRI uses magnets to take pictures of the brain. There will be six scanning appointments in the study, with two scans each. Appointments will be about a month apart.\n* Take a single dose of a study agent during each scanning appointment. The study agent will be taken after the first fMRI. There are three study agents in total: modafinil, d-serine, and a placebo. Each participant will take each study agent twice during the study.\n* Play brain games on a computer that measure decision making, thinking, and problem solving skills",[27,28,29,30,31,32,33,34,35],"Psychosis","Schizophrenia Disorder","Schizoaffective Disorder","Major Depressive Disorder With Psychotic Features","Bipolar Disorder With Psychotic Features","Psychosis NOS","Schizophreniform Disorder","Psychotic Disorder","Cognition",[35,37,38,39],"Decision Making","fMRI","Psychosis spectrum disorders","RECRUITING","2026-07-22",{"date":43,"type":44},"2026-07-23","ACTUAL",{"date":46,"type":44},"2026-07-17",{"date":48,"type":21},"2030-04-30",{"name":50,"class":51},"University of Minnesota","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":61,"enrollmentInfo":62,"targetDuration":64,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":5},"100647753","transition-care-for-fep-100647753","NCT07713849","Transition Care for FEP","Adapting and Improving Transition Care for First Episode Psychosis","TCT FEP","Inclusion Criteria:\n\n* Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, major depressive disorder with psychotic features, schizophreniform disorder, or psychosis NOS\n* The diagnosis of one of the psychotic disorders has a duration of less than two years.\n* Able to read, speak, and understand English, which will be assessed through observation.\n* Able and willing to provide written informed consent or assent, in cases where caregivers are considered legal guardians. Dr. Shima, co-I of the study, is a forensic psychiatrist, and particularly adept at judging such ability. Drs. Erickson and Keedy have conducted studies in individuals with psychotic disorders, including FEP and in the context of clinical trials, for years, and are similarly competent to judge whether individuals can provide informed consent. Finally, we will also use an Evaluation to Sign Consent form that documents subjects' verbalized understanding of key aspects of the study.\n* have an estimated IQ of \\> 65, assessed by the Wechsler Test of Adult Reading\n* Eligible caregivers\u002Fproxy informants must be identified by the participant or clinical team as being involved in the participant's discharge planning or follow-up care, be able to provide informed verbal consent, and be able to speak and read English sufficiently to complete study questionnaires. Caregivers may include family members, close supports, or legally authorized representatives.\n\nExclusion Criteria:\n\n* Individuals with substance-induced psychosis or psychosis due to a medical condition will not be included in the study. We will use the Structured Clinical Interview for DSM-5 as well as medical records, and if the subject gives permission, caregiver information in this process\n* Individuals who do not meet criteria for a first episode of psychosis","40 Years",{"count":63,"type":21},75,"6 Weeks","OBSERVATIONAL","This study is testing a new approach to help people with first episode psychosis transition successfully from the hospital to outpatient mental health care. Many patients lose contact with services after they leave the hospital, which can lead to worse outcomes. The investigators have developed a Transition Care Team (TCT) that works with patients while they are in the hospital and continues to support them after discharge. The team provides therapy, case management, and coordination with community programs that offer ongoing care. The main goal of the study is to find out if this new program increases the number of patients who successfully begin outpatient treatment after hospitalization, compared to usual care. The investigators will also look at whether the program improves symptoms, functioning, and overall well-being.",[68,31,69,30,32],"Schizoaffective Disorders","Schizophrenia Disorders",[71,72,73,74,75,76],"First Episode Psychosis","Bipolar","Inpatient Unit","Transition Care Team","Schizophrenia","Coordinated Specialty Care","2026-07-14",{"date":79,"type":44},"2026-07-20",{"date":81,"type":44},"2026-05-06",{"date":83,"type":21},"2029-05-06",{"name":85,"class":51},"University of Chicago"]