Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-06 @ 5:14 AM
Study NCT ID:
NCT06422559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-18', 'studyFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2024-05-18', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of severity of manic symptoms before and after treatment', 'timeFrame': 'One year for completion of the study', 'description': 'We will use Young Mania Rating Scale.\\_Young Mania Rating Scale:assess severity of manic symptoms, clinician rated,\\<=12(remission)13\\_19(minimal symptoms)20\\_25(mild mania)26\\_37(moderate mania)38\\_60 severe mania'}, {'measure': "Comparison of the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis.", 'timeFrame': 'One year for completion of the study', 'description': "We will use Clinical Global Impression Severity Scale.\\_Clinical Global Impression Severity Scale:rate the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis,1 normal not at all ill,2 borderline mentally ill,3 mildly ill,4 moderately ill,5 markedly ill,6 severely ill,7 extremely ill"}, {'measure': 'Comparison of severity and impact of insomnia before and after treatment', 'timeFrame': 'One year for completion of the study', 'description': 'We will use Insomnia Severity Index scale.\\_Insomnia Severity Index:assess the nature, severity and impact of insomnia,0\\_7(absence insomnia) 8\\_14(subthreshold insomnia)15\\_21(moderate insomnia)22\\_28(severe insomnia)'}, {'measure': 'Comparison of depressive symptoms before and after treatment', 'timeFrame': 'One year for completion of the study', 'description': 'We will use Hamilton Depression Rating Scale.\\_Hamilton Depression Rating Scale:assess the severity of depressive symptoms, clinician rated,0\\_7(normal range)8\\_16(mild severity)17\\_23(moderate severity)\\>23(severe depression)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '33224435', 'type': 'BACKGROUND', 'citation': 'Chang J, Chu Y, Ren Y, Li C, Wang Y, Chu XP. Maintenance treatment of transcranial magnetic stimulation (TMS) for treatment-resistant depression patients responding to acute TMS treatment. Int J Physiol Pathophysiol Pharmacol. 2020 Oct 15;12(5):128-133. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/33224435/', 'label': 'PMC 7675193'}]}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to learn if accelerated Intermittent Theta Burst Stimulation can improve symptoms of 30 participants with Unipolar depression in higher manner than symptoms of 30 participants with bipolar depression', 'detailedDescription': 'We will apply stimulatory TMS protocol for participants with Unipolar depression and participants with bipolar depression using MagVenture MagPro R30 stimulator with the Cool-B65 coil'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age:18\\_65 years\n* Sex:male and female\n* Patients with Unipolar depression and bipolar depression diagnosis confirmed by SCID according to DSM5\n* No pharmacological change in the last 4 weeks before the beginning of the stimulantion cycle\n* Pharmacological resistance\n\nExclusion Criteria:\n\n* Patients complaining of psychosis.Substance Use Disorder.current suicidal ideation.major medical and neurological disorder\n* Patients complaining of epilepsy\n* pregnancy and breastfeeding\n* peacemaker spinal or bladder stimulator\n* History of skull surgery and trauma\n* presence of metallic foreign body'}, 'identificationModule': {'nctId': 'NCT06422559', 'briefTitle': 'Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression', 'orgStudyIdInfo': {'id': 'MD.22.12.731'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with unipolar depression', 'description': 'Participants with Unipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks', 'interventionNames': ['Device: Transmagnetic stimulation', 'Device: TMS']}, {'type': 'EXPERIMENTAL', 'label': 'Participants with bipolar depression', 'description': 'Participants with bipolar depression will receive 30 sessions of TMS.10 sessions a week for 3 weeks', 'interventionNames': ['Device: Transmagnetic stimulation', 'Device: TMS']}], 'interventions': [{'name': 'Transmagnetic stimulation', 'type': 'DEVICE', 'description': 'Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil', 'armGroupLabels': ['Participants with bipolar depression', 'Participants with unipolar depression']}, {'name': 'TMS', 'type': 'DEVICE', 'description': 'Stimulatory TMS protocol using MagVenture MagPro R30 stimulator with the Cool-B65 coil', 'armGroupLabels': ['Participants with bipolar depression', 'Participants with unipolar depression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'contacts': [{'name': 'Institutional R. Board', 'role': 'CONTACT', 'email': 'IRB.MFM@hotmail.com', 'phone': 'Egypt +2050-2202773:2202746'}, {'name': 'Warda F. Aboelez', 'role': 'CONTACT', 'phone': '01018186408'}, {'name': 'Shaimaa E. Mohamed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Shaimaa E. Mohamed', 'role': 'CONTACT', 'email': 'shaimaa_eldesokey151990@yahoo.com', 'phone': 'Egypt 01014947026'}, {'name': 'Warda F. Aboelez', 'role': 'CONTACT', 'phone': '01018186408'}], 'overallOfficials': [{'name': 'Hala A. El-boraie', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor'}, {'name': 'Ibrahim H. Rashed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant professor'}, {'name': 'Hassan M. Sonbol', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}