Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-04-13 @ 3:58 PM
Study NCT ID:
NCT02562703
Status:
UNKNOWN
Last Update Posted:
2015-09-29
First Post:
2015-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
tVNS for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-25', 'studyFirstSubmitDate': '2015-09-25', 'studyFirstSubmitQcDate': '2015-09-25', 'lastUpdatePostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Hamilton Depressive Rating Scale version 17 items (HDRS-17)', 'timeFrame': 'Change from baseline in depressive symptoms at 2 weeks', 'description': 'This clinical trial has as primary objective to evaluate the effect of the tVNS on depressive symptoms measured by the Hamilton Depressive Rating Scale version 17 items (HDRS-17) in patients with moderate / severe depressive episode.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '26358492', 'type': 'RESULT', 'citation': 'Trevizol AP, Sato IA, Bonadia B, Liquidato BM, Barros MD, Cordeiro Q, Shiozawa P. Trigeminal Nerve Stimulation (TNS) for Major Depressive Disorder in Pregnancy: A Case Study. Brain Stimul. 2015 Sep-Oct;8(5):988-9. doi: 10.1016/j.brs.2015.07.034. Epub 2015 Jul 23. No abstract available.'}, {'pmid': '25150403', 'type': 'RESULT', 'citation': 'Shiozawa P, Duailibi MS, da Silva ME, Cordeiro Q. Trigeminal nerve stimulation (TNS) protocol for treating major depression: an open-label proof-of-concept trial. Epilepsy Behav. 2014 Oct;39:6-9. doi: 10.1016/j.yebeh.2014.07.021. Epub 2014 Aug 23.'}, {'pmid': '23773978', 'type': 'RESULT', 'citation': 'Cook IA, Schrader LM, Degiorgio CM, Miller PR, Maremont ER, Leuchter AF. Trigeminal nerve stimulation in major depressive disorder: acute outcomes in an open pilot study. Epilepsy Behav. 2013 Aug;28(2):221-6. doi: 10.1016/j.yebeh.2013.05.008. Epub 2013 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive episode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients between 18 and 69 years\n2. patients with a diagnosis of depression according to the SCID\n3. score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode)\n4. agreement to participate in the study as recommended in the IC.\n\nExclusion Criteria:\n\n1. patients with psychiatric indication for hospitalization\n2. patients with psychiatric comorbidity\n3. patients with a diagnosis of personality disorder\n4. presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.'}, 'identificationModule': {'nctId': 'NCT02562703', 'briefTitle': 'tVNS for Depression', 'organization': {'class': 'OTHER', 'fullName': 'Santa Casa Medical School'}, 'officialTitle': 'Transcutaneous Vagus Nerve Stimulation for Treating Major Depressive Disorder: a Phase II, Randomized, Double-blind Clinical Trial', 'orgStudyIdInfo': {'id': 'tVNS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACTIVE tVNS', 'description': 'tVNS will be applied by the external simulator (Monarch). The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 250 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia .The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed over the mastoid process bilaterally. The study protocol will follow the rational of our previous trials with TNS.', 'interventionNames': ['Device: Transcutaneous Vagus Nerve Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'SHAM tVNS', 'description': 'tVNS will be applied by the external simulator (Monarch). The stimulation will be turned off after 60 seconds following previous trials.', 'interventionNames': ['Device: Transcutaneous Vagus Nerve Stimulation']}], 'interventions': [{'name': 'Transcutaneous Vagus Nerve Stimulation', 'type': 'DEVICE', 'description': 'tVNS will be applied by the external simulator (Monarch). The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 250 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia .The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed over the mastoid process bilaterally. The study protocol will follow the rational of our previous trials with TNS.', 'armGroupLabels': ['ACTIVE tVNS', 'SHAM tVNS']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alisson P Trevizol, MD', 'role': 'CONTACT', 'email': 'alisson.trevizol@hotmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santa Casa Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinator - Interdisciplinary Center for Clinical Neuromodulation', 'investigatorFullName': 'Pedro Shiozawa', 'investigatorAffiliation': 'Santa Casa Medical School'}}}}