Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-03-09 @ 7:22 AM
Study NCT ID:
NCT00657735
Status:
UNKNOWN
Last Update Posted:
2012-01-05
First Post:
2008-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double Blind Randomized Controlled, H1 Coil In Subjects With Bipolar Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-04', 'studyFirstSubmitDate': '2008-04-08', 'studyFirstSubmitQcDate': '2008-04-11', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in the Hamilton depression rating scale score', 'timeFrame': '7 weeks'}], 'secondaryOutcomes': [{'measure': 'Clinical antidepressant remission at the end of the treatment, defined as exit Hamilton Depression Rating Scale <10.', 'timeFrame': '7 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bipolar', 'depression', 'prefrontal', 'cortex', 'antidepressant', 'response'], 'conditions': ['Bipolar Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression , currently treated with mood stabilizer and previously unsuccessfully treated with antidepressant medications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:• Outpatients\n\n* Diagnosed by two senior psychiatrists as suffering from bipolar depression (BP1, BP2) episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID), with additional requirement of duration for the current episode ≥ 4 weeks and CGI ≥ 4.\n* Rating on HAM-D (17 items) \\>20 and item 1 ≥2 at the screening visit.\n* Age: 18-65 years.\n* Gave informed consent for participation in the study.\n* Negative answers on safety screening questionnaire for transcranial magnetic stimulation\n* Taking mood stabilizing medication (e.g., lithium) on an acceptable range of dosage according to recent blood examination or antipsychotic medication as mood stabilizers prescribed by their treating physician\n* According to the treating physician the patient is compliant in taking the mood-stabilizing medication.\n* Medication resistance to at least two different antidepressant treatments, defined as resistance to a minimum of 2 antidepressant drug trials of adequate dose and duration in the current episode or previous episodes defined as a minimum level of 3 on the ATHF per antidepressant drug-trial.\n* Patients who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to 3 or more anti-depressant medications in the current or a previous episodes.\n* If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.\n* Able to tolerate psychotropic medication washout and no psychotropics during the H-coil deep brain rTMS other than benzodiazepine at equivalent dose of up to 3 mg lorazepam every day.\n* Right hand dominance.\n\nExclusion Criteria:• Diagnosis as suffering from other diagnosis on axis 1 (like: schizophrenia, geriatric depression).\n\n* Diagnosis as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder.\n* Substantial suicidal risk as judged by the treating psychiatrist.\n* Attempted suicide in the past year.\n* Patients with a bipolar cycle of less than 30 days.\n* History of epilepsy or seizure in first degree relatives.\n* History of head injury.\n* History of any metal in the head (outside the mouth).\n* Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.\n* History of frequent or severe headaches.\n* History of migraine.\n* History of hearing loss.\n* Known history of cochlear implants\n* History of substance abuse within the past 6 months (except nicotine and caffeine) or alcoholism\n* Pregnancy or not using a reliable method of birth control.\n* Unstable Systemic and metabolic disorders.\n* Unstable neurological or medical disease\n* Inadequate communication with the patient.\n* Under custodial care.\n* Participation in current clinical study or clinical study within 30 days prior to this study.'}, 'identificationModule': {'nctId': 'NCT00657735', 'briefTitle': 'Double Blind Randomized Controlled, H1 Coil In Subjects With Bipolar Depression', 'organization': {'class': 'OTHER', 'fullName': 'Shalvata Mental Health Center'}, 'officialTitle': 'A Prospective Double Blind Randomized Controlled Trial To Explore The Tolerability, Safety And Efficacy Of The H1-Coil Deep Transcranial Magnetic Stimulation (TMS) In Subjects With Bipolar Depression', 'orgStudyIdInfo': {'id': 'BR-BIP-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Deep TMS treatment', 'interventionNames': ['Device: H-Coil deep TMS']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': 'inactive stimulation', 'interventionNames': ['Device: sham']}], 'interventions': [{'name': 'H-Coil deep TMS', 'type': 'DEVICE', 'otherNames': ['H1 coil dTMS'], 'description': '20 daily deep rTMS treatments', 'armGroupLabels': ['1']}, {'name': 'sham', 'type': 'DEVICE', 'description': 'inactive treatment', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hod HaSharon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Eiran v Harel, MD', 'role': 'CONTACT'}], 'facility': 'shalvataMHC', 'geoPoint': {'lat': 32.15934, 'lon': 34.8932}}], 'centralContacts': [{'name': 'Yechiel Levkovitz, MD', 'role': 'CONTACT', 'email': 'ylevk@clalit.org.il'}, {'name': 'Oded Meiron, PhD student', 'role': 'CONTACT', 'email': 'odedmei@clalit.org.il'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shalvata Mental Health Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brainsway', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}