[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Douglas Mental Health University Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":341},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,49,83,116,144,179,201,236,261,286,312],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100473460","investigating-the-neural-correlates-of-cognitive-function-in-psychosis-patients-and-non-psychiatric-controls-with-cannabis-use-100473460",false,"NCT05445180","Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use","Investigating the Neural Correlates of Cognitive Function Associated With Cannabis Abstinence in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use","Inclusion Criteria:\n\n* Able to provide informed consent in English or French\n* Heavy cannabis use (defined as weekly cannabis use for at six months) and\u002For DSM-5 diagnosis of CUD\n* Have a Full-Scale IQ ≥ 75\n* Meet DSM-5 criteria for a psychotic disorder (psychosis patient arm only)\n* Be an outpatient receiving a stable dose of medication(s) for at least two months (psychosis patient arm only)\n* Clinically stable (as measured by the PANSS-6, total score \\\u003C30) (psychosis patient arm only)\n\nExclusion Criteria:\n\n* current SUD (other than CUD)\n* MRI contraindications\n* Positive urine screen for psychoactive substances other than cannabis, nicotine, or caffeine\n* Current suicidal or homicidal ideation\n* Head injury requiring hospitalization or loss of consciousness \\> 5 minutes\n* Current medical diseases that requires hospitalization or regular monitoring\n* Being pregnant\n* DSM-5 Axis 1 diagnosis (other than CUD) (non-psychiatric controls only)\n* Taking psychotropic medication",true,"ALL","16 Years","80 Years",{"count":21,"type":22},134,"ESTIMATED","INTERVENTIONAL",[25],"NA","Cognitive impairment is well established in people with psychosis and is associated with cannabis use. The current study will investigate the neurobiological basis of cognitive change associated with 28-days of cannabis abstinence in people with psychosis and non-psychiatric controls with cannabis use. Participants will be randomized to a cannabis abstinent group or a non-abstinent control group and will undergo magnetic resonance imaging at baseline and following 28-days of abstinence. This study will help characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use and its recovery which may guide the development of novel interventions for problematic cannabis use.",[28,29,30,31,32,33,34,35],"Psychotic Disorders","Cannabis Use Disorder","Cannabis Dependence","Cannabis Use","Schizophrenia; Psychosis","Cognitive Dysfunction","Memory Impairment","Neuroimaging","RECRUITING","2026-05-19",{"date":39,"type":40},"2026-05-22","ACTUAL",{"date":42,"type":40},"2022-04-21",{"date":44,"type":22},"2027-05",{"name":46,"class":47},"Douglas Mental Health University Institute","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100625886","accelerated-neuromodulation-therapy-for-negative-symptoms-of-schizophrenia-100625886","NCT07428460","Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia","Accelerated, Neuronavigated Neuromodulation Therapy for Negative Symptoms of Schizophrenia","TMSNS","Inclusion Criteria:\n\n* Confirmed diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder\n* Duration of illness ≥ 6 months\n* Clinically significant negative symptoms\n* Must have been on a stable pharmacological treatment for at least 4 weeks before entering the study\n* Clinicians will confirm that patients' negative and positive symptoms have been stable per their clinical opinion for at least 3 months.\n* Participants must be able to provide informed consent\n* Ability to undergo MRI scanning\n\nExclusion Criteria:\n\n* Pregnancy, lactation, or an intrauterine device\n* History of electroconvulsive therapy (ECT) in the past 6 months\n* Use of licit or illicit substances (excluding cannabis) during the week of treatment and in the 24 hours prior to fMRI scans\n* Contraindications for TMS\n* Previous treatment with rTMS\n* Documented history of significant intellectual disability\n* Primary diagnosis of psychotic disorder secondary to a medical condition or substance-induced psychosis.","18 Years","65 Years",{"count":60,"type":22},75,[25],"The goal of this clinical trial is to learn if an accelerated form of neuromodulation therapy can help improve negative symptoms of schizophrenia. Negative symptoms can include low motivation, reduced emotional expression, and difficulty with social interaction. The study will also look at how safe and tolerable this treatment is when given over a short period of time.\n\nParticipants will be randomly assigned to receive either active neuromodulation therapy or sham (placebo) stimulation. The study will also compare two different ways of choosing where to place the stimulation.\n\nWe want to learn whether this accelerated treatment approach is safe and feasible for people with schizophrenia, whether negative symptoms improve after treatment, and whether the way the stimulation site is chosen affects outcomes\n\nParticipants will be asked to complete clinical interviews and questionnaires, undergo a brain scan, receive neuromodulation therapy or sham stimulation over five consecutive days, and attend follow-up visits after treatment\n\nThis study is being conducted at three hospitals in Canada and is designed to help plan larger studies in the future.",[64],"Schizophrenia and Predominant Negative Symptoms",[66,67,68,69,70,71,72,73],"Negative symptoms","Neuromodulation therapy","Non-invasive brain stimulation","Accelerated treatment","Schizophrenia spectrum disorders","TMS","Transcranial Magnetic Stimulation","Outpatient treatment","2026-02-19",{"date":76,"type":40},"2026-02-23",{"date":78,"type":22},"2026-02-01",{"date":80,"type":22},"2028-05",{"name":46,"class":47},3,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":16,"sex":17,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":48},"100609343","phase-2-daridorexant-for-alzheimer-disease-prevention-100609343","NCT07213349","Daridorexant for Alzheimer Disease Prevention","Double Blind Clinical Trial of Daridorexant (Dual Orexin Receptor Antagonist) for Alzheimer Disease Prevention","PAD-DORA","Inclusion Criteria:\n\n* Without dementia as determined by: MoCA \\>21 or MMSE \\> 24 or Clinical Dementia Rating \\\u003C1\n* Minimum of 6 years of formal education\n* Stable psychoactive medication for 1 month prior to screening with no intention to change dose during treatment period\n* Capacity to provide written consent in English or French\n\nExclusion Criteria:\n\n* Clinical diagnosis of major neurocognitive disorder\n* Unstable psychiatric condition:\n* Clinically significant active suicidal ideations\n* Unstable medical condition in the opinion of the investigator.\n* Known or suspected history of drug or alcohol dependence or abuse within one year of the screening visit\n* Currently taking a DORA\n* Allergy or significant adverse reaction to DORA\n* Use of benzodiazepines or z-drugs \\> 2 times per week in the last month.\n* Use of major and moderate CYP3A4 inducers and inhibitors\n* Use of strong central nervous system depressants, opioids, strong analgesics, antipsychotics, sedative antidepressants.\n* Active use of cholinesterase inhibitors or memantine\n* Women who are breast feeding or pregnant\n* Severe obstructive sleep apnea (OSA)\\*\n* Clinically significant non-treated rapid eye movement (REM) sleep behavior disorder, restless leg syndrome or parasomnia;\n* Diagnosis of narcolepsy","50 Years","90 Years",{"count":94,"type":22},240,[96],"PHASE2","This study will evaluate whether daridorexant, a DORA sleep medication, can support brain health by promoting the clearance of proteins linked to the development and progression of Alzheimer's disease. The trial is preventive and is open to participants who do not have Alzheimer's disease dementia, regardless of whether or not they experience sleep problems.",[99],"Alzheimer Disease (AD)",[101,102,103,104,105,106,107],"Prevention","Sleep","Amyloid","Tau","Cognitive decline","Dual Orexin Receptor Antagonist (DORA)","Daridorexant","2025-12-15",{"date":110,"type":40},"2025-12-19",{"date":112,"type":40},"2025-10-14",{"date":114,"type":22},"2029-12",{"name":46,"class":47},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":122,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":48},"100593173","spatial-memory-training-and-cognitive-function-100593173","NCT07002996","Spatial Memory Training and Cognitive Function","Inclusion Criteria:\n\n1. Age 55 years and above.\n2. Primary language is English or French.\n3. Individuals having received a diagnosis of Mild Cognitive Impairment (MCI).\n\nExclusion Criteria:\n\n1. Self-reported having either of the following:\n\n   Current post-traumatic stress disorder and\u002For generalized anxiety disorder; Substance use disorder; Significant heart disease (i.e., stroke occurring during 5 years prior to study assessment or cardiac disease non-stabilized with medication); Severe Depression, or a Geriatric Depression Scale (GDS) score greater than 12; Current insomnia disorder.\n2. Current medications for sleep problems, or use of medications that affect sleep.\n3. Use of antidepressant and anti-anxiety medication for less than 3 months prior to study entry.\n4. Use of analgesics with codeine (or other opioids).\n5. Use of antipsychotic medication (past or current).\n6. Having undergone brain surgery or ECT.\n7. Self-reported colour-blindness.\n8. General anesthesia in the past year.\n9. Current smoker.\n10. Suspected or confirmed traumatic brain injury during the last 24 months.\n11. Motion sickness or intolerant to virtual reality tasks.\n12. Cholesterol or hypertension medication for less than 3 months or changes expected within the next 9 months.\n13. History or presence of neurological or psychiatric disorders (other than MCI) that in the opinion of the investigator may compromise patient safety or study objectives.\n14. Current severe medical conditions (e.g. untreated diabetes, cancer) that in the opinion of the investigator may compromise patient safety or study objectives.\n15. For female participants, severe menopausal symptoms, including hot flashes (determined from the Greene climacteric scale - any participants scoring over 15 is excluded).\n16. Use of computer games that are designed to help with memory or general cognition.\n17. Presence of any medical or psychological condition that, in the opinion of the principal investigator, may compromise the study objectives.\n18. Presence of contra-indications for MRI scanning.","55 Years",{"count":124,"type":22},80,[25],"Mild cognitive impairment (MCI) is often considered a transitional stage between normal aging and dementia, particularly Alzheimer's disease (AD). Patients with MCI have subjective memory complaints corroborated by standard neuropsychological tests but remain functionally autonomous. One of the first brain regions to show AD pathology is the hippocampus (HPC). Reduction in HPC volume is a strong predictor of AD dementia. Therefore, improvement or restoration of HPC structure and function is thus an attractive target for improvement in memory and AD prevention strategies. In the current study, the investigators propose to examine the effects of a 3-month long spatial memory program on spatial memory and the hippocampus in patients diagnosed with MCI. Neuropsychological tests are also administered before and after the training to assess the effects of the intervention on cognition. In our previous research, the investigators have shown that spatial memory intervention program (SMIP) improves cognition and hippocampal based spatial memory compared to controls.",[128],"Mild Cognitive Impairment",[130,131,132,133,134,135],"Memory","Spatial Memory","Hippocampus","Cognitive Training","Cognitive Decline","Aging","2025-07-18",{"date":138,"type":40},"2025-07-23",{"date":140,"type":40},"2025-06-15",{"date":142,"type":22},"2030-12-30",{"name":46,"class":47},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":16,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":151,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":154,"conditions":155,"keywords":160,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":48},"100591287","dialog-understanding-disorganisation-a-language-focused-global-initiative-in-psychosis-100591287","NCT06978465","DIALOG: Understanding Disorganisation: A Language-focused Global Initiative in Psychosis","DIALOG","Inclusion Criteria:\n\n\\- English or French speaking participants, male or female; age 18-65 years. Patients who have been previously diagnosed by their treating physician based on the Diagnostic and Statistical Manual of Mental Disorders 5 Edition (DSM 5) criteria for schizophrenia or schizoaffective disorder. Ethnically and socioeconomically diverse individuals from urban catchments. Women are under-represented in psychosis studies but across sexes disorganisation is equally severe. We aim for \\>40% women in our samples via broader inclusion criteria not limited to schizophrenia.\n\nHealthy Controls group-matched with the patients for age (within 2 years), and sex matched to patient sample; and have no personal or first-degree family history of Severe Mental Disorders (SMD).\n\nExclusion Criteria:\n\nPregnancy; substance-induced psychosis with no SMD; neurological speech or auditory impairment, contraindication for MRI; Not able to give informed consent (if this is in doubt at the time of referral, we will formally test it). Not be able to speak French or English for clinical interactions; participants who are not proficient will be excluded.",{"count":152,"type":22},150,"OBSERVATIONAL","Disorganized speech, language and communication, also called 'formal thought disorder,' is a key part of severe mental illnesses like psychosis and mood disorders. When someone's communication is disorganized, it makes social interactions difficult, increases stigma and affect educational and employment opportunities. However, we do not know much about why this happens. This project, called DIALOG, aims to understand the brain's role in disorganization by studying everyday language use instead of traditional clinical ratings. The study will look at how our brain creates predictions during interactions and how these processes break down in psychosis. This international project also includes experts with personal experience of mental illness. The study will look at speech, thinking patterns, symptoms, and brain waves. The goal of the study is to see if brain waves are disrupted in psychosis, especially in language-related problems. Speech tasks, like describing pictures, talking about a significant event, and telling a story are administered. These tasks will be audio-recorded for analysis. Non-invasive brain imaging technologies such as Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) are utilized. MRI creates images of the brain's structure, while MEG records magnetic activity from neurons, shown as brain waves. The MRI machine uses a large magnet to create images, and MEG captures small magnetic field changes from brain activity. Participants will also undergo clinical and neurocognitive assessments. The study will combine Large Language Models (LLM) applied to speech recordings with large scale participant data from neuroimaging tools (MRI\u002FMEG). The goal of DIALOG is to pioneer a computationally informed, molecular-to systems-level account of disorganisation, identifying the precise mechanisms that can be targeted with novel treatments. This project aims to gather speech and neuroimaging data from Montreal \\[100 healthy volunteers and 50 patients with psychosis\\], Groningen \\[17 synaptic density PET scans\\], Cardiff \\[600 participants\\] and Marburg \\[1600 participants\\] with schizophrenia, schizoaffective disorder or mood disorders and user acceptability data at Pavia and Melbourne.",[156,157,158,159],"Psychosis","Schizophrenia Disorders","Bipolar Affective Disorder","Depressive Disorder",[161,162,163,164,165,166,167,168,169],"disorganization","MEG","language disorder","neural activity","MRI","formal thought disorder","large language models","natural language processing","psycholinguistics","NOT_YET_RECRUITING","2025-05-11",{"date":173,"type":40},"2025-05-18",{"date":175,"type":22},"2025-05-19",{"date":177,"type":22},"2030-04-30",{"name":46,"class":47},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":82},"100591320","predicting-psychotic-relapse-using-speech-based-early-detection-100591320","NCT06978894","Predicting Psychotic Relapse Using Speech-Based Early Detection","MOTS+","Inclusion Criteria:\n\n* Age must be 16 years and older\n* Diagnosis must meet DSM-5 criteria for psychotic disorders, including schizophrenia, schizoaffective disorder, or related conditions\n* Fluency in English or French\n* Must be currently receiving treatment through an EPI program\n\nExclusion Criteria:\n\n* Severe comorbid speech or language disorders (e.g., aphasia)\n* Primary diagnosis of non-psychotic disorders\n* Inability to provide consent or complete assessments",{"count":187,"type":22},250,"Psychotic disorders, including schizophrenia and affective psychosis, are severe mental health conditions marked by recurrent episodes that contribute to long-term disability. Relapses, characterized by the re-emergence of psychotic symptoms after remission, are a critical factor in the progression of these disorders, increasing risks such as suicide, cognitive impairment, and unemployment. This study aims to develop a novel, speech-based digital model to predict relapses in individuals with psychosis. Building on previous research into language abnormalities in schizophrenia, the study will employ a longitudinal design across Early Psychosis Intervention (EPI) clinics in Ontario and Quebec to advance relapse prediction",[156],[191,168,192,193,194],"psychosis","relapse","speech","relapse prediction",{"date":173,"type":40},{"date":197,"type":40},"2024-05-27",{"date":199,"type":22},"2029-07-01",{"name":46,"class":47},{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":16,"sex":17,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":212,"studyType":153,"phases":4,"briefSummary":213,"conditions":214,"keywords":221,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":235,"locationsCount":48},"100591286","behavioural-development-long-term-outcomes-and-opportunities-to-optimize-youth-mental-health-trajectories-100591286","NCT06978452","Behavioural Development, Long-term Outcomes and Opportunities to Optimize Youth Mental Health Trajectories","BLOOM","Inclusion Criteria:\n\nYouth between 9 to 25 years of age at inclusion, who are able to read and understand either French or English, with at least one parent or legal guardian available to consent for those under 18 years of age.\n\nSpecific eligibility criteria:\n\nHelp-seeking group: At least one help-seeking contact made with a primary care clinical service provider or agency (e.g, paediatric\u002Ffamily physician clinic, CLSC or Aire Ouverte) for a mental health concern (i.e., clinical needs).\n\nNon help-seeking group:\n\nAt least one of the birth parents or siblings have received psychiatric care for a diagnosis of DMDs (i.e., family needs) OR Being in contact with community agencies that provide youth-centred social services for food, housing, social discrimination (e.g., racialized youth, LGBTQ2SIA+) (i.e., social needs) OR Having a diagnosed chronic physical illness that is expected to require treatment for \\>12 months (e.g., diabetes, asthma to name a few) (i.e., physical health needs)\n\nExclusion Criteria:\n\n* Due to the requirements of assessment procedures, youth who cannot communicate verbally due to known neurological conditions or intellectual disabilities will not be included. Youth who are already diagnosed with one of the DMDs by a physician and currently prescribed a treatment targeting the diagnosed condition (pharmacological or psychotherapeutic interventions), will not be eligible for inclusion.\n\nImportantly, no one will be excluded based on sex, gender, health insurance status, ethnicity, income status, ability to travel or living arrangements. If a participant initially approached through the referral pathways for non help-seeking individuals turns out to have had at least one help-seeking contact for a mental health concern (i.e., clinical needs), the participant will still be included but classified as part of the help-seeking group. We anticipate non help-seeking referrals to satisfy more than one criteria. Their occurrence and distribution will be recorded in detail as part of our assessment procedure.","9 Years","25 Years",{"count":211,"type":22},560,"5 Years","Behavioural Development, Long-term Outcomes and Opportunities to Optimize Youth Mental Health (BLOOM) is a project that aims to overcome age and diagnostic boundaries to generate person-specific longitudinal profiles of mental health in youth aged 9 to 25. The overarching objective is to lay the informational foundation to accurately predict both clinical outcomes and opportunities to optimize health trajectories. This project will recruit youth in need without any mental health diagnosis and follow them annually for 5 years. The present study includes assessment of antecedents, opportunities and outcomes that will establish eligibility for preventive interventions",[215,216,156,217,218,219,220],"Depression - Major Depressive Disorder","Bipolar","Eating Disorder NOS","ADHD","Substance Use Disorder (SUD)","OCD",[222,223,224,225,226,227,228,193,229,230],"antecedents","mental health prevention","resilience","access to care","help-seeking","youth in needs","biomarker","language","cognition",{"date":173,"type":40},{"date":233,"type":40},"2024-07-01",{"date":199,"type":22},{"name":46,"class":47},{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":16,"sex":17,"minAge":57,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":246,"conditions":247,"keywords":248,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":48},"100591313","hyeeg-discourse-in-psychosis-a-neurobehavioural-study-100591313","NCT06978803","HYEEG Discourse in Psychosis: A Neurobehavioural Study","DISCOURSE-NB","Inclusion Criteria:\n\n1. English or French-speaking participants (as dyads matched for language preference).\n2. Ages 18-60 years.\n3. Patients meeting the operational criteria for schizophrenia or schizoaffective illness as previously diagnosed by their treating psychiatrist, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria (Zipursky et al., 2020).\n4. Patients with less than 5 years of illness onset, based on the time of starting treatment with antipsychotic medication.\n\nExclusion Criteria:\n\n1. Participants should not have a primary diagnosis of Alcohol or Drug abuse or addiction (however, co-morbid substance abuse with a primary diagnosis of psychotic disorder is not an exclusion criterion).\n2. Participants should not have a severe medical disorder that would explain psychotic symptoms.\n3. Participants should not have a past or current history of a primary neurological disorder that can affect speech output\n4. Participants with IQ below 70 or a concurrent pervasive developmental disorder (e.g., autism) will also be excluded.","60 Years",{"count":245,"type":22},110,"This multimodal study explores the mechanisms underlying social dysfunction in individuals with schizophrenia. It focuses on the relationship between disorganized communication and social interaction, aiming to identify measurable markers of disorganized communication and link them to clinical symptoms and social functioning.\n\nKey Research Questions:\n\nHow do neural and behavioural synchrony contribute to social impairments in schizophrenia?\n\nWhat roles do interbrain synchrony, motor imitation, reaction time, and verbal coherence play in disorganized communication?\n\nParticipants will:\n\n1. Engage in structured and semi-structured real-time social interactions while undergoing dual-brain electroencephalogram (EEG) hyperscanning to measure neural and behavioural activity.\n2. Perform nonverbal tasks such as motor imitation and reaction time assessments to investigate coordination and behavioural synchrony patterns.\n3. Participate in a clinical interview that evaluates verbal production, thought coherence, and speech organization.\n\nBy combining these assessments, the study aims to advance our understanding of how social and communication impairments manifest in schizophrenia. The findings will contribute to developing improved diagnostic tools and targeted interventions, ultimately supporting patients in achieving better social functioning and quality of life.",[156,157],[249,191,250,251,252,253,254,168],"hyperscanning eeg","imitation tasks","interbrain synchrony","motor imitation","motor behaviour","speech disorganization",{"date":173,"type":40},{"date":257,"type":40},"2024-01-16",{"date":259,"type":22},"2026-12-31",{"name":46,"class":47},{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":17,"minAge":268,"maxAge":243,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":48},"100487795","vr-cbt-with-inuit-in-quebec-100487795","NCT05631743","VR-CBT With Inuit in Quebec","A Virtual Reality-assisted Cognitive Behavior Therapy With Inuit in Quebec - a Proof-of-concept Randomized Controlled Trial","Inclusion Criteria:\n\n1. Self-identify as Inuk\n2. Live in Montreal\n3. be between 14 to 60 years of age\n4. be proficient in English or French\n5. No history of cardiac conditions\n6. No history of epilepsy\n7. Can provide an emergency contact\n8. Tolerance of VR headset\n9. Tolerance of sensors\n10. Has no current suicidal or homicidal risk\n11. No history of psychosis or schizophrenia\n12. Current stable mood\n13. Is generally mentally stable\n14. Score less than 8 on the Alcohol Use Disorders Identification Test C\n15. Score less than 3 on the Drug Abuse Screen Test (10 item version)\n16. Not have had any change in psychoactive medications during 4 weeks preceding screening and inclusion to the study\n\nExclusion Criteria:\n\n1. does not identify as Inuk\n2. youth below the age of 14 and adults above the age of 60.\n3. self-reported history of psychosis or schizophrenia\n4. current substance abuse, as measured by two screens (AUDIT-C, DAST-10)\n5. other mental or physical condition that might preclude them from the trial (i.e., pre-existing heart conditions, convulsions, acute mental health risk).","14 Years",{"count":270,"type":22},40,[25],"The study design is a two-arm randomized controlled pilot trial. The investigators will recruit Inuit in Montreal and randomly assign them to two treatment groups (n=20 each). The active psychotherapy group will receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at the clinic and guided by a psychotherapist. The VR-CBT will aim at improving emotion regulation. The comparison group will use a VR self-management program, Calm Place, for guided relaxation during ten weeks at home. To evaluate outcome in both groups, the researchers will measure self-reports of emotion regulation, affect, distress and well-being, as well as a psychophysiological reactivity paradigm pre-post treatment.",[274],"Emotion Regulation",[276,277],"virtual reality","cognitive behavioural therapy","2025-02-10",{"date":280,"type":40},"2025-02-12",{"date":282,"type":40},"2023-07-15",{"date":284,"type":22},"2025-12-31",{"name":46,"class":47},{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":296,"briefSummary":297,"conditions":298,"keywords":301,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":311},"100490078","promoting-cognitive-health-in-schizophrenia-100490078","NCT05661448","Promoting Cognitive Health in Schizophrenia","Promoting Cognitive Health in Schizophrenia: A National Collaborative Effort to Implement Online Psychological Interventions","iCogCA","Inclusion Criteria:\n\n* Diagnosis of affective or non-affective psychosis or related disorder;\n* Follow-up and treatment by a clinician at one of the services mentioned above;\n* Participants symptomatically stable and capable of using the online platforms and participating in intervention groups, as judged by their primary clinicians (i.e., psychiatrist, case manager);\n* Participants must have access to a private space (i.e., a room where the participant can be alone) to ensure confidentiality for the group;\n* Participants must be able to nominate an emergency contact and to agree to allow researchers to contact their clinician and\u002For emergency services in the event of an emergency during study procedures.\n\nExclusion Criteria:\n\n* Intellectual disability;\n* Hospitalization at the time of recruitment;\n* Inability to speak or read English or French;\n* High suicide risk as per evaluation.",{"count":295,"type":22},390,[25],"The goal of this clinical trial is to effectively implement virtually-delivered interventions in mental health institutions nationwide to improve the cognitive health of individuals living with schizophrenia. The main objectives are:\n\n* To determine the clinical effectiveness of two virtual cognitive health interventions (i.e., Action-Based Cognitive Remediation or MetaCognitive Training).\n* To evaluate our implementation strategy involving the virtual delivery of cognitive health interventions combined with a digital learning platform to train mental health practitioners.\n\nParticipants will be assessed for the severity of symptoms, cognitive performance, and overall functioning before and after receiving the intervention. Qualitative interviews will also be conducted with participants and therapists to evaluate the implementation strategies.",[299,300],"Schizophrenia","Cognition",[302,303,304,191],"intervention","cognitive remediation","metacognition",{"date":280,"type":40},{"date":307,"type":40},"2023-04-15",{"date":309,"type":22},"2029-08-31",{"name":46,"class":47},5,{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":16,"sex":17,"minAge":57,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":23,"phases":322,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":82},"100406210","phase-3-brexpiprazole-treatment-for-bipolar-i-depression-100406210","NCT04569448","Brexpiprazole Treatment for Bipolar I Depression","Low-Dose Adjunctive Brexpiprazole in the Treatment of Bipolar I Depression: An Open-Label Study","Patient Inclusion Criteria:\n\n* Age: 18-75\n* Male or female\n* Bipolar Disorder type I or type II\n* Current treatment-resistant depressive episode (with MADRS \\>\u002F= 24 and item 2 (reported sadness) \\>\u002F= 3) for a minimum of 2 weeks but \\\u003C\u002F= 52 weeks at screening visit and baseline visit\n* Patients must have failed at least one other treatment for the current depressive episode\n* If female and of childbearing potential, is using an adequate method of contraception. Adequate methods of contraception include abstinence; oral contraceptive pill or surgically implanted device; intra-uterine device; condom plus spermicidal foam or jelly; or tubal ligation\n* Is treated with a mood stabilizer (lithium and\u002For valproate and\u002For lamotrigine and\u002For quetiapine \\\u003C\u002F= 100mg\u002Fday)\n* The following laboratory values are within normal limits at Screening: CBC with differential; ferritin; extended electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); thyroid function test(s); kidney function tests; hemoglobin A1c; lipid profile; prolactin\n* Normal EKG at Screening\n* Patient is able to give his(her) consent\n\nPatient Exclusion Criteria:\n\n* Is at high risk of suicide as defined by a score of \\>\u002F= 3 to item 10 of MADRS and\u002For in the clinical opinion of the investigator\n* Hypo(mania) episode with YMRS \\>\u002F= 8\n* Psychotic symptoms as defined by a score of \\>\u002F= 4 to item 8 (content) of YMRS and\u002For in the opinion of the investigator\n* Is treated with fluoxetine OR carbamazepine\n* Is treated with risperidone OR olanzapine OR quetiapine \\> 100mg\u002Fday OR ziprazidone OR any other antipsychotic\n* Is pregnant or lactating or absence of contraceptive treatment\n* Drug abuse or dependence as per DSM-V (MINI)\n* Unstable medical condition\n* Other unstable and\u002For untreated psychiatric condition, organic brain disorder, unstable and\u002For untreated medical condition such as hypothyroidism, hyperthyroidism, diabetes, cardiac condition, hypertension\n* Deficit in vitamin B12 or folate\n* Rapid cycling (more than 4 mood episodes per year)\n* Active or history of difficulty to swallow\n* Seizures not currently controlled with medications\n* Orthostatic hypotension defined as a drop in systolic blood pressure of at least 20 mmHg or of diastolic BP of at least 10 mmHg within 3 minutes of standing\n* A history of clinically significant cardiovascular disorders and cardiac arrhythmias\n* A low white blood cell count\n* Known eye disease\n* Involuntary, irregular muscle movements, especially in the face\n* Known hypersensitivity to Brexpiprazole and any components of its formulation\n* Known lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption, because Brexpiprazole and placebo tablets contain lactose (a disaccharide of glucose and galactose)\n* Active inflammatory disease including lupus, colitis, Crohn's disease, psoriasis, irritable bowel syndrome (IBS)\n* Mild or major neurocognitive disorder\n* Previous history of sensitivity\u002Flow tolerance to medications metabolized by CYP 2D6 inhibitors, or CYP 3A4 inducers\n\nControl Inclusion Criteria:\n\n* Age: 18-75\n* Male or female\n* No current or past history of any psychiatric disorder\n* Patients must have failed at least one other treatment for the current depressive episode\n* If female and of childbearing potential, is using an adequate method of contraception. Adequate methods of contraception include abstinence; oral contraceptive pill or surgically implanted device; intra-uterine device; condom plus spermicidal foam or jelly; or tubal ligation\n* The following laboratory values are within normal limits at Screening: CBC with differential; ferritin; extended electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); thyroid function test(s); kidney function tests; hemoglobin A1c; lipid profile; prolactin\n* Normal EKG at Screening\n* Patient is able to give his(her) consent\n\nControl Exclusion Criteria:\n\n* Alcohol or drug abuse\n* Deficit in vitamin B12 or folate\n* Seizures not currently controlled with medications\n* History of clinically significant cardiovascular disorders and cardiac arrhythmias\n* Mild or major neurocognitive disorder\n\nPatient\u002FControl Exclusion Criteria for MRI:\n\n* Pacemaker\n* Heart\u002Fvascular clip\n* Metal prosthesis\n* Metal fragments in body\n* Transdermal patch\n* Aneurysm clip\n* Prosthetic valve\n* Claustrophobia\n* Pregnant","75 Years",{"count":321,"type":22},58,[323],"PHASE3","Bipolar disorder (BD) is a frequent and lifelong recurrent mood disorder with treatment-resistant depressive episodes. Importantly, depressive symptoms and cognitive decline are major determinants of functionality and quality of life in this clinical population. There is robust evidence that individuals with BD have neurocognitive deficits (especially in memory and executive functioning domains) compared to the healthy population. These deficits are present in all mood states and can greatly affect patients' functional capacity, often more so than mood symptoms themselves. Many pharmacological treatments for BD adversely affect cognition, and those that are beneficial can be difficult to use. There is thus a pressing need to identify a safe, easy-to-use medication that can target both cognitive deficits and depressive symptoms in BD. It is expected that Brexpiprazole adjunctive treatment will be efficacious in treating BD type I and type II depression by improving mood symptoms, as well as cognitive capacity and global functioning, and that such changes will be accompanied by concurrent alterations in associated brain structures.",[326],"Bipolar Depression",[328,329,300,330,331,132,332],"Brexpiprazole","Treatment-resistant depression","Functioning","Rest-Activity rhythm","CRP","2024-08-05",{"date":335,"type":40},"2024-08-07",{"date":337,"type":40},"2021-05-10",{"date":339,"type":22},"2025-02",{"name":46,"class":47},""]