Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06982820
Status:
RECRUITING
Last Update Posted:
2025-10-28
First Post:
2025-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D059445', 'term': 'Anhedonia'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind: neither participants nor clinicians assessing them will have information regarding the treatment arm.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, randomized, double-blind, controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-26', 'studyFirstSubmitDate': '2025-04-29', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HDRS-21', 'timeFrame': 'Change from baseline to week 12 (post training visit)', 'description': 'Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression.'}], 'secondaryOutcomes': [{'measure': 'SHAPS-C', 'timeFrame': 'Change from baseline to week 12 (post-training visit)', 'description': 'Snaith-Hamilton-Pleasure scale - is a 14- item self-administered measure of anhedonia symptoms.'}, {'measure': 'HDRS-21', 'timeFrame': 'Change from baseline to 3-month FU visit', 'description': 'Hamilton Rating Scale for Depression - the maximum score is 64. A score above 20 is considered a severe depression.'}, {'measure': 'CGI-I', 'timeFrame': 'Change from baseline to week 12 (post-training visit)', 'description': "Clinical global impression - The 7-point CGI-I scale rates improve with a (1) representing a very much improved' patient and (7) representing a patient who has become 'very much worse' due to treatment. The rating (4) represents a patient displaying no change from the treatment."}, {'measure': 'CGI-I', 'timeFrame': 'Change from week 12 to 3-Month follow-up Assessment', 'description': "Clinical global impression - The 7-point CGI-I scale rates improve with a (1) representing a very much improved' patient and (7) representing a patient who has become 'very much worse' due to treatment. The rating (4) represents a patient displaying no change from the treatment."}, {'measure': 'PHQ-9', 'timeFrame': 'Change from baseline to week 12 (post-Training visit)', 'description': 'Patient Health Questionnaire-9 - The PHQ-9 is a nine-item depressive symptom diagnostic tool.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Major Depressive Disorder (MDD)', 'Anhedonia', 'Depression'], 'conditions': ['Depressive Disorder, Major']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'The study is comprised of the Screening Visit, Baseline Assessment, Pre-training Visit, 20 NF Training Visits (two training visits per week over 10 weeks), two Booster NF Training Visits (Week 16, and Week 20, and the 3-Month Follow-up Assessment Visit (Week 24).\n\nParticipants will receive 20 NF sessions.\n\nThe study will test the following hypothesis:\n\n* H0: M(Anhedonic)RS-EFP = M(Anhedonic)Sham-EFP\n* H1: M(Anhedonic)RS-EFP ≠ M(Anhedonic)Sham-EFP\n\nWhere:\n\nM(Anhedonic)RS-EFP and M(Anhedonic)Sham-EFP are the mean changes from baseline HDRS-17 score in the Active and Sham arms of the Anhedonic MDD participants.\n\n\\*HDRS-21 is administered for cluster analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/AUD) 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/SNRIs 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.'}, 'identificationModule': {'nctId': 'NCT06982820', 'briefTitle': 'Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'GrayMatters Health Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CLP015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active arm', 'description': 'Participants randomized into the Active arm will receive reward system EEG-fMRI pattern (RS-EFP) Neuro Feedback (NF) Prism training as an adjunct to SOC.', 'interventionNames': ['Device: Prism Training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham arm', 'description': 'Participants randomized into the Sham arm will receive a Sham EFP-NF training with the same schedule as the active arm, adjunct to SOC.', 'interventionNames': ['Device: Prism Training']}], 'interventions': [{'name': 'Prism Training', 'type': 'DEVICE', 'otherNames': ['Sham Training'], 'description': 'Participants will complete 20 Prism training sessions. The Prism training sessions take place twice a week over a 10-week period, with a minimum of one night of sleep between sessions. Participants will also receive two single booster sessions, 4 weeks and 8 weeks after their last NF session completed.', 'armGroupLabels': ['Active arm', 'Sham arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35404', 'city': 'Tuscaloosa', 'state': 'Alabama', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mallory C. Bates', 'role': 'CONTACT', 'email': 'mallorybates@novusneuro.com', 'phone': '205-909-7305'}, {'name': 'Timothy W. Prestley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Novus Psychiatry', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Tirrell', 'role': 'CONTACT', 'email': 'ETirrell@Butler.org', 'phone': '401-455-6633'}, {'name': 'Linda Carpenter, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Adar Shani, MSc', 'role': 'CONTACT', 'email': 'adar@graymatters-health.com', 'phone': '+972-54-2347770'}, {'name': 'Jennifer Yarden, PhD', 'role': 'CONTACT', 'email': 'jennifer@graymatters-health.com', 'phone': '+972-52-4897823'}], 'overallOfficials': [{'name': 'Aron Tendler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GrayMatters Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GrayMatters Health Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}