Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-02 @ 9:12 AM
Study NCT ID:
NCT07159061
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurofeedback to Treat Depression - 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery Asberg Depression Rating Scale (MADRS)', 'timeFrame': '3 months', 'description': "Clinician administered scale to assess the severity of depression. MADRS scores will be compare the effect of real-time neurofeedback vs sham neurofeedback on depression outcome in patients with MDD. A MADRS score of 16 or higher is needed in order to be eligible to be enrolled in the study. The higher the MADRS score, the more depressed the individual will be. A lower MADRS score indicates that the individual's depressive symptoms have improved. A higher MADRS score indicates that the individual's depressive symptoms have worsened."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder (MDD)']}, 'descriptionModule': {'briefSummary': "This study tests the efficacy of a new psychotherapeutic strategy for reducing negative attention bias (and therefore depression severity) in participants with MDD. This real-time fMRI neurofeedback therapy uses cloud-based pattern classification to decode a patient's attentional state and dynamically modulate task stimuli (in a closed loop) based on this state.", 'detailedDescription': 'The investigators will compare cloud based real time fMRI feedback with placebo (sham feedback) in reducing negative attention bias and depressive symptoms. This study will be the first dose-finding test of real-time fMRI effect on negative attention bias. Measures include: Structured Clinical Interview for DSM-5 (SCID), Clinician-administered diagnostic exam, Montgomery Asberg Depression Rating Scale (MADRS), Clinician-administered scale used to assess the severity of depression, State-Trait Anxiety Inventory (STAI), Self-report questionnaire used to measure types of anxiety and mood symptoms, Mood and Anxiety Symptom Questionnaire (MASQ), Negative perseveration during a go/no-go task, Go/no-go task with overlaid face/scene stimuli; brain response triggers next stimulus, Negative gaze, Negative gaze collected in gaze data following each real time fMRI feedback session'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gender, inclusive\n* Adult aged 18 - 65\n* Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for MDD according to the Clinician-Administered MDD Scale for DSM-5 (unipolar depression or bipolar II depressed)\n* Scores at least a minimum score of 16 on Montgomery Asberg Depression Rating Scale (MADRS)\n* Normal cognition\n* Participants must be able to read and understand English\n* Participants must be able to provide consent\n\nExclusion Criteria:\n\n* Pregnancy (female participants)\n* Outside age range\n* MRI contraindications (medical implant, claustrophobia, etc.)\n* Use of psychoactive medication (including antidepressants) or currently in therapy\n* Neurological disorder or any condition that in the view of the PI could impact brain data, cause depression, require medication that could cause depressive symptoms, or otherwise result in participant being unfit for study (for example, co-morbid psychotic, neurological disorders, developmentally or cognitively disabled/impaired, active alcohol or drug abuse/dependence within the past 6 months).\n* Non-English speaking\n* Non-correctable vision loss\n* Refusal to provide informed consent\n* representing an active suicide risk'}, 'identificationModule': {'nctId': 'NCT07159061', 'briefTitle': 'Neurofeedback to Treat Depression - 2', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Reducing Neural Perseveration Through Closed Loop Real Time fMRI Neurofeedback to Alleviate Depressive Symptoms', 'orgStudyIdInfo': {'id': '849298-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Active Neurofeedback', 'description': 'R33 Phase: Three training sessions. Each training session contains 32 minutes of active neurofeedback runs.', 'interventionNames': ['Behavioral: Active Closed Loop Real Time fMRI Neurofeedback']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Comparator: Sham Neurofeedback', 'description': 'R33 Phase: Three training sessions. Each training session contains 32 minutes of sham (placebo) neurofeedback runs.', 'interventionNames': ['Behavioral: Sham Closed Loop Real Time fMRI Neurofeedback']}], 'interventions': [{'name': 'Active Closed Loop Real Time fMRI Neurofeedback', 'type': 'BEHAVIORAL', 'description': 'Active neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)', 'armGroupLabels': ['Active Comparator: Active Neurofeedback']}, {'name': 'Sham Closed Loop Real Time fMRI Neurofeedback', 'type': 'BEHAVIORAL', 'description': 'Sham (placebo) neurofeedback to target neural mechanisms underlying attentional bias in participants with major depressive discover (MDD)', 'armGroupLabels': ['Sham Comparator: Sham Neurofeedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Prociuk', 'role': 'CONTACT', 'email': 'lmari@pennmedicine.upenn.edu', 'phone': '(215) 573-4229'}, {'name': 'Yvette Sheline, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Neuromodulation in Depression and Stress', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Yvette Sheline, M.D.', 'role': 'CONTACT', 'email': 'cndslab@pennmedicine.upenn.edu', 'phone': '(215) 746-2637'}], 'overallOfficials': [{'name': 'Yvette Sheline, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Neuromodulation in Depression and Stress, University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will only be shared amongst the study sites.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'McLure Professor of Radiology, Neurology and Psychiatry', 'investigatorFullName': 'Yvette Sheline', 'investigatorAffiliation': 'University of Pennsylvania'}}}}