Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-04 @ 3:30 PM
Study NCT ID:
NCT05985356
Status:
COMPLETED
Last Update Posted:
2025-11-04
First Post:
2023-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromodulation for Comorbid Hoarding Disorder and Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067836', 'term': 'Hoarding Disorder'}, {'id': 'D060845', 'term': 'Hoarding'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-02', 'studyFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Savings Inventory -- Revised', 'timeFrame': 'change from baseline to 8 weeks', 'description': 'self-reported symptoms of hoarding disorder'}, {'measure': 'Hamilton Rating Scale for Depression', 'timeFrame': 'change from baseline to 8 weeks', 'description': 'depression symptom severity'}], 'secondaryOutcomes': [{'measure': 'Hoarding Rating Scale', 'timeFrame': 'change from baseline to 8 weeks', 'description': 'self-reported symptoms of hoarding disorder'}, {'measure': 'Patient Health Questionnaire - 9', 'timeFrame': 'change from baseline to 8 weeks', 'description': 'self-reported symptoms of depression'}, {'measure': 'Neuropsychological Global Deficit Score', 'timeFrame': 'change from baseline to 8 weeks', 'description': 'neurocognition composite'}, {'measure': 'resting state functional connectivity', 'timeFrame': 'change from baseline to 4 weeks', 'description': 'connectivity between subgenual nucleus accumbens and dorsolateral prefrontal cortex as measured by functional magnetic resonance imaging'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['TMS', 'Transcranial magnetic stimulation'], 'conditions': ['Hoarding Disorder', 'Hoarding', 'Depression']}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to evaluate whether intermittent theta burst stimulation (iTBS) is effective for treating depression in people who have depression and chronic hoarding disorder (HD). The study will also evaluate whether this treatment can improve HD symptoms, cognitive performance, and brain region connectivity. The study team will investigate how the treatment works for depression, as well as other factors that can enhance or hinder treatment, such as pre-treatment level of depression, cognitive performance, or brain region connectivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male, female, or non-gender conforming individuals (i.e. those who do not identify as male or female)\n4. All racial and ethnic groups\n5. Ages 18 to 70\n6. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per HAM-D and DIAMOND.\n7. Meets criteria for current Hoarding Disorder, per SIHD\n8. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms\n9. Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period\n10. No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)\n11. No contraindications to MRI (passes MRI safety screening questionnaire)\n12. Able to commit to the treatment schedule\n13. Able to complete assessment procedures in English\n14. Intact decision-making capacity and ability to provide voluntary informed consent\n\nExclusion Criteria:\n\n1. History of other neurological condition including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy\n2. Implanted medical devices that are not explicitly recognized as MRI safe, including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed\n3. Active manic or psychotic illness per DIAMOND\n4. Current substance use disorder per DIAMOND\n5. Current active suicidal or spontaneously disclosed homicidal ideation. Active suicidal ideation for this study is defined as a score of 3 or greater on the HAMD-17 and/or 3 or more on the PHQ-9.\n6. Pregnant or intending to become pregnant within the study period; breastfeeding\n7. Other sensory conditions or illnesses precluding participation in assessments or treatment\n8. Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy\n9. Taking medication that lowers seizure threshold\n10. Previous failed treatment with rTMS, iTBS, or ECT"}, 'identificationModule': {'nctId': 'NCT05985356', 'briefTitle': 'Neuromodulation for Comorbid Hoarding Disorder and Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Neuromodulation for Comorbid Hoarding Disorder and Depression', 'orgStudyIdInfo': {'id': 'RG106837'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iTBS', 'description': 'intermittent Theta Burst Stimulation (a form of transcranial magnetic stimulation) targeting the left dorsolateral prefrontal cortex', 'interventionNames': ['Device: iTBS']}], 'interventions': [{'name': 'iTBS', 'type': 'DEVICE', 'otherNames': ['rTMS'], 'description': 'iTBS targeting the left dorsolateral prefrontal cortex; 20 sessions over 4 weeks.', 'armGroupLabels': ['iTBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Elizabeth Twamley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data can be de-identified and made available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Elizabeth Twamley', 'investigatorAffiliation': 'University of California, San Diego'}}}}