[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GrayMatters Health Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100591622","self-neuro-modulation-therapy-for-major-depressive-disorder-mdd-with-anhedonia-100591622",false,"NCT06982820","Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia","A Prospective, Randomized, Double-blind, Controlled Study to Produce Guidelines for Integrating Prism for MDD Therapy (Reward System [RS] Upregulation) and to Demonstrate Its Superiority Over Sham Therapy","Inclusion Criteria:\n\n1. Primary Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM5TR) - HDRS-17 score of ≥20, SHAPS-C score of ≥25.\n2. Fluency in written and spoken English.\n3. Able intellectually to understand the instructions\n4. Ability to give signed, informed consent either written or electronic (via REDCap eConsent).\n5. Normal or corrected-to-normal vision and hearing.\n6. Ability to adhere to the study schedule.\n7. Completed at least one antidepressant treatment course at an adequate dose and duration in the current episode per the ATRQ.\n\nExclusion Criteria:\n\n1. Contraindications to MRI (e.g., metal in the body, claustrophobia).\n2. Any suicidal behavior in the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) assessed using Columbia -Suicide Severity Rating Scale (C-SSRS) prior to screening and during the screening period.\n3. Diagnosis for current moderate or severe substance or alcohol use disorder (SUD\u002FAUD) within the past month (as defined in DSM-5-substance use disorder).\n4. Any unstable medical condition, as per the clinical judgement of the investigator.\n5. Any change in, or initiation of, fluoxetine within the past 8 weeks or of other SSRIs\u002FSNRIs antidepressants, bupropion, stimulants, or other psychiatric medications within the past 4 weeks.\n6. Recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted.\n7. Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.","ALL","22 Years","75 Years",{"count":20,"type":21},170,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this research is to learn more about a new treatment for individuals with Major Depressive Disorder (MDD) with heightened symptoms of anhedonia (i.e. loss of pleasure or interest in activities). The treatment is called Prism, and it is a software device intended for a novel form of neurofeedback training to be used in a clinic setting.\n\nDuring this study, the subject will use different techniques to measure brain activities, including magnetic resonance imaging (MRI) and electroencephalography (EEG).",[27],"Depressive Disorder, Major",[29,30,31],"Major Depressive Disorder (MDD)","Anhedonia","Depression","RECRUITING","2026-04-30",{"date":35,"type":36},"2026-05-01","ACTUAL",{"date":38,"type":36},"2025-06-25",{"date":40,"type":21},"2027-08-30",{"name":42,"class":43},"GrayMatters Health Ltd.","INDUSTRY",3,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":5},"100581747","the-prism-conformity-trial-for-post-traumatic-stress-disorder-in-adolescents-100581747","NCT06854328","The Prism Conformity Trial for Post-Traumatic Stress Disorder in Adolescents","A Prospective, Single Arm, Open Label Trial, to Confirm Safety and Effectiveness of Prism, as an Adjunct to Standard of Care, in Adolescents With Post-Traumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n1. Ages 12 to 21 years.\n2. Any gender.\n3. Diagnosis of PTSD, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).\n4. ≥1 year since index trauma.\n5. For candidate participants under 18 years old: Willingness and ability to provide assent, with the participant's legal guardian able and willing to provide informed consent for their study participation.\n6. For candidate participants 18 years old and above: Willingness and ability to provide informed consent for their study participation.\n7. English speaking, writing and reading.\n8. Normal or corrected-to-normal vision and hearing.\n\nExclusion Criteria:\n\n1. Have completed one or more full courses of trauma-focused therapy in the past (i.e., Eye Movement Desensitization and Reprocessing \\[EMDR\\], Prolong Exposure Therapy etc.), eligibility will be deemed upon the clinical judgement of the investigator.\n2. Diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder.\n3. Any mood or anxiety disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), that has been the primary focus of mental health treatment within the 6 months prior to screening, based on the clinical judgment of the site investigator.\n4. Diagnosis of autism spectrum requiring substantial support, intellectual disability of mild severity at discretion of investigator.\n5. Diagnosis of moderate or severe substance use disorder within the last 3 months of the screening visit (as defined in DSM-5-substance use disorder) or at the screening visit.\n6. Current symptom level of moderate or severe ADHD (as defined in DSM-5 ADHD disorder) or at screening visit.\n7. Any change in- or initiation of- psychotropic medications within the past 4 weeks. At the time of recruitment, subjects must have no intention of changing their medication or psychotherapy during the study duration.\n8. Any suicidal behavior within the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior), prior to screening and during the screening period.\n9. Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy \\[CPT\\], Prolonged Exposure \\[PE\\], Eye Movement Desensitization and Reprocessing \\[EMDR\\]). However, continuation of established maintenance supportive therapy will be permitted.\n10. Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury \\[TBI\\] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days).\n11. Any unstable medical condition, as per the clinical judgement of the investigator.\n12. Enrollment in another interventional clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.\n13. Female subjects who are pregnant, nursing, or who plan to become pregnant while in the trial.","12 Years","21 Years",{"count":55,"type":21},45,[24],"Prism is a software as a medical device (SaMD) to be prescribed by clinicians as an adjunct to the standard of care treatment of patients with PTSD. The Prism software device runs on a laptop using an EEG signal input (g).Nautilos PRO (K171669).\n\nThe primary objective of the study is to extend the use of the FDA cleared Prism for PTSD (K222101) to an adolescent population and to confirm the safety of fifteen (15±3) EEG-NF training sessions using the Prism software in reducing PTSD-related symptoms in adolescents. The study aims to demonstrate the safety profile of Prism, having no device-related serious adverse events (SAEs), consistent with findings in the adult population, throughout the course of Prism treatment in an adolescent population.",[59],"Post-Traumatic Stress Disorder in Adolescence",[61,62],"Neurofeedback","PTSD in adolescent",{"date":64,"type":36},"2026-05-05",{"date":66,"type":36},"2025-06-11",{"date":68,"type":21},"2026-11-01",{"name":42,"class":43},""]