Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-28 @ 5:43 PM
Study NCT ID:
NCT01353092
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
2011-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-25', 'studyFirstSubmitDate': '2011-04-27', 'studyFirstSubmitQcDate': '2011-05-11', 'lastUpdatePostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton depression rating scale', 'timeFrame': 'Every week for 11 weeks', 'description': 'Interviewer based rating scale to measure severity of depression'}], 'secondaryOutcomes': [{'measure': 'UKU', 'timeFrame': 'Every week for 11 weeks', 'description': 'Side effect scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Randomized Controlled Trial', 'Major depression', 'Hamilton', 'PEMF'], 'conditions': ['Treatment Resistant Depression']}, 'referencesModule': {'references': [{'pmid': '20385376', 'type': 'BACKGROUND', 'citation': 'Martiny K, Lunde M, Bech P. Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression. Biol Psychiatry. 2010 Jul 15;68(2):163-9. doi: 10.1016/j.biopsych.2010.02.017. Epub 2010 Apr 10.'}, {'pmid': '26242577', 'type': 'DERIVED', 'citation': 'Bech P, Timmerby N, Martiny K, Lunde M, Soendergaard S. Psychometric evaluation of the Major Depression Inventory (MDI) as depression severity scale using the LEAD (Longitudinal Expert Assessment of All Data) as index of validity. BMC Psychiatry. 2015 Aug 5;15:190. doi: 10.1186/s12888-015-0529-3.'}]}, 'descriptionModule': {'briefSummary': 'In this study patients with treatment resistant depression, as defined by Harold Sackeim, is subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients are randomized into two groups. In group A patients receive active treatment both morning and afternoon. In group B patients receive one sham and one active treatment. The study is double-blind as neither the assessors or patients are aware of treatment allocation. Each session lasts 30 minutes. Patients are psychometrically assessed weekly for depression severity and side effect. After this intervention period patients are followed for further three weeks without PEMF treatment. Patients are on unchanged medication for the whole of the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment resistant Major depression (grade 3 Sackeim criteria)\n* Age above 18 and below 85\n* Hamilton (17 item version) score above 12\n* Unchanged psychopharmacological treatment for last five weeks.\n\nExclusion Criteria:\n\n* suicidality above 2 on item three on Hamilton scale or,earlier PEMF treatment\n* dementia or similar cognitive impairment\n* psychotic disorder\n* abuse of alcohol or drugs\n* pregnant or lactating women\n* insufficient birth control measures'}, 'identificationModule': {'nctId': 'NCT01353092', 'acronym': 'PEMFII', 'briefTitle': 'Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression', 'organization': {'class': 'OTHER', 'fullName': 'Hillerod Hospital, Denmark'}, 'officialTitle': 'PEMF Treatment in Patients With Treatment Resistant Depression in On-going Antidepressant Drug Therapy. A Randomized, Double-blind, Clinically Controlled, Dose-response PEMF Trial for a Duration of Eight Weeks', 'orgStudyIdInfo': {'id': '26.04.2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active PEMF twice daily', 'description': 'Re5 treatment helmet using Pulsating ElectroMagnetic Field:\n\nIntervention: 30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon', 'interventionNames': ['Device: Re5 Pulsating ElectroMagnetic Fields']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active PEMF once daily', 'description': 'Re5 treatment helmet using Pulsating ElectroMagnetic Field:\n\nIntervention: 30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)', 'interventionNames': ['Device: Re5 Pulsating ElectroMagnetic Fields (PEMF)']}], 'interventions': [{'name': 'Re5 Pulsating ElectroMagnetic Fields', 'type': 'DEVICE', 'otherNames': ['T-PEMF = Transcranially applied PEMF'], 'description': 'Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF):\n\n30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon', 'armGroupLabels': ['Active PEMF twice daily']}, {'name': 'Re5 Pulsating ElectroMagnetic Fields (PEMF)', 'type': 'DEVICE', 'otherNames': ['T-PEMF = Transcranially applied PEMF'], 'description': 'Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF):\n\n30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)', 'armGroupLabels': ['Active PEMF once daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hilleroed', 'country': 'Denmark', 'facility': 'Psychiatric Research Unit, Mental Health Centre North Zealand'}], 'overallOfficials': [{'name': 'Marianne Lunde, Coordinator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mental Health Centre North Zealand Psychiatric Research Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Per Bech', 'investigatorAffiliation': 'Hillerod Hospital, Denmark'}}}}