[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"schizophrenia--schizoaffective-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:schizophrenia--schizoaffective-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,79],{"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":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100644968","phase-1-a-cognitive-mobile-intervention-for-motivation-in-psychotic-disorders-100644968",false,"NCT07674914","A Cognitive Mobile Intervention for Motivation in Psychotic Disorders","A User-Informed Digital Therapeutic for Specific Cognitive Disabilities to Improve Mental Health in Schizophrenia and Related Mental Illnesses","Inclusion Criteria:\n\n* diagnosis of schizophrenia, schizoaffective disorder, or a related psychotic disorder\n* own a smartphone\n* English speaking\n* experiencing challenges with cognitive functioning\n* no changes to antipsychotic medication in past month\n\nExclusion Criteria:\n\n* history of neurological disorder\n* traumatic brain injury with loss of consciousness \\> 10 minutes or behavioral sequelae.","ALL","18 Years","60 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The goal of this study is to develop and test the impact of a smartphone-based working memory cognitive training digital therapeutic for individuals with schizophrenia or a related disorder.",[28],"Schizophrenia \u002F Schizoaffective Disorder",[30,31],"schizophrenia","psychosis","NOT_YET_RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":21},"2026-09",{"date":40,"type":21},"2028-08",{"name":42,"class":43},"University of Alabama at Birmingham","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100640709","nst-spark-open-label-phase-1-sttr-ignite-100640709","NCT07593456","NST-SPARK Open-Label Phase 1 STTR (IGNITE)","Investigating a Gamified NegatIve-symptom Therapeutic Based on Evidence-based Cognitive Therapy (IGNITE)","IGNITE","Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder or unspecified psychotic disorder\n* Clinically stable, defined as no acute positive psychotic symptom exacerbation or recent hospitalization or medication changes within the last month.\n* Moderate to severe negative symptoms: CAINS MAP subscale \\>17 (28).\n* Sufficient functioning and capacity to consent and participate in a longitudinal study.\n* Actively engaged in outpatient treatment.\n* Able and willing to use a smartphone and maintain internet connection during use (through wifi or data plan).\n\nExclusion Criteria:\n\n* Safety risk (e.g., suicide attempt or homicidal ideation within 12 weeks)\n* Issues that prevent subject from using the smartphone app: e.g., hearing, vision, or other relevant physical disability\n* IQ \\\u003C 70 based on clinical and historical information\n* Cognitive impairment limiting engagement in study\n* Prominent mood symptoms as defined by active manic, hypomanic or depressive episode.\n* Has previously undergone cognitive behavioral therapy for psychosis or recovery-oriented cognitive therapy for negative symptoms.","65 Years",{"count":55,"type":21},30,[57],"NA","Schizophrenia Spectrum disorders (SSD) are among the most devastating psychiatric disorders. Prominent negative symptoms such as low motivation, anhedonia, asociality, and emotional flattening are experienced by up to 60% of individuals with SSD and are often considered to be the greatest contributors to functional disability. Currently, there are no FDA-approved or cleared medications or therapeutics targeting negative symptoms of schizophrenia. In this phase I proposal, North Shore Therapeutics (NST) is collaborating with the Feinstein Institutes of Medical Research (FIMR; Northwell Health) and the University of Pennsylvania (Penn) to develop a novel augmented reality (AR) therapeutic (NST-SPARK) targeting negative symptoms in individuals with SSD. NST-SPARK is a smartphone application that delivers Recovery-oriented Cognitive Therapy (CT-R) via gamified AR experiences to provide experiential learning that dismantles maladaptive beliefs. Preliminary findings suggest that this approach is feasible, acceptable, and may reduce defeatist beliefs associated with negative symptoms. NST-SPARK v.2.0 is being developed in partnership with a lived experience advisory panel. NST-SPARK v2.0 will deliver a 12-week course of treatment and will be developed over 10 development sprints spanning 9 months. In the second phase, the investigators will introduce NST-SPARK v2.0 to individuals with SSD (n=30) and moderate to severe negative symptoms for 12 weeks in a single-arm open-label study. The primary outcome is the efficacy of NST-SPARK v.2.0 in reducing experiential negative symptoms. Secondary outcomes include efficacy in reducing defeatist beliefs; efficacy in improving functioning; user statistics quantifying adherence to the prescribed sessions; qualitative, semi-structured feedback to guide future product development. This study will set the stage for FDA-informed phase II trials.",[28],[30,61,62,63,64,65,66,67],"recovery-oriented cognitive therapy (CT-R)","cognitive behavioral therapy (CBT)","prescription digital therapeutic","software as a medical device (SaMD)","augmented reality (AR)","negative symptoms","avolition","2026-05-13",{"date":70,"type":36},"2026-05-18",{"date":72,"type":21},"2027-03-01",{"date":74,"type":21},"2028-08-31",{"name":76,"class":77},"North Shore Therapeutics, Inc.","INDUSTRY",2,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":44},"100374761","brain-imaging-of-cognition-inn-schizophrenia-and-depression-100374761","NCT04159662","Brain Imaging of Cognition Inn Schizophrenia and Depression","Inclusion Criteria:\n\n* age 18-60 years\n* current Intelligence Quotient (IQ) \\> 70 as measured by the Wechsler Abbreviated Scale of Intelligence (WASI)\n* the ability to read and speak fluent English\n* a diagnosis of schizophrenia, schizoaffective or major depression disorder\n* stable medication for more than one month\n\nExclusion Criteria:\n\n* significant neurological or other medical disorders that may produce cognitive impairment\n* a recent history of substance abuse or dependence (within the past 3 months)\n* any magnetic resonance imaging (MRI) contraindications (e.g. metallic head implant, history of seizure, pacemaker)\n* decisional incapacity requiring a guardian\n* taking medications that are rated as Anticholinergic Burden (ACB) Score 3 (severe) or taking benzodiazepines on a daily basis\n* Finally, participants could not be severely symptomatic at the time of study enrolment to ensure that they could understand and complete all study assessments. This criterion was defined as a score ≤34 on the Montgomery-Åsberg Depression Rating Scale (MADRS; Montgomery \\& Åsberg, 1979) for the MDD group and a score ≤95 on the Positive and Negative Syndrome Scale (PANSS; Kay et al., 1987) for the SZ group.",{"count":86,"type":21},90,"OBSERVATIONAL","Schizophrenia and depression are among the most disabling disorders in all of medicine. Cognitive deficits play a key role in patients' disability, affecting their capacity to contribute actively to society by sustaining employment or academic activity. Moreover, cognitive difficulties tend to persist even after the stabilization of other clinical symptoms. Verbal memory and emotion regulation are two important cognitive domains that are impaired in schizophrenia and depression and are associated with patients' functional outcomes. In this study, brain imaging is used to investigate the brain mechanisms underlying these cognitive deficits in these populations.",[28,90],"Depression \u002F Major Depressive Disorder","RECRUITING","2026-03-19",{"date":94,"type":36},"2026-03-23",{"date":96,"type":36},"2019-12-12",{"date":98,"type":21},"2026-10-01",{"name":100,"class":43},"The Royal Ottawa Mental Health Centre"]