Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT00287703
Status:
COMPLETED
Last Update Posted:
2009-05-29
First Post:
2006-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-28', 'studyFirstSubmitDate': '2006-01-31', 'studyFirstSubmitQcDate': '2006-02-06', 'lastUpdatePostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Rating Scale score (depression)', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'AQT, measure of concentration', 'timeFrame': 'weekly'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Major depression', 'Treatment resistant', 'PEMF', 'AQT', 'Hamilton'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '20385376', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'About 30% of patients with major depression are treatment resistant to pharmacological treatment. In the search for new methods to treat depression a great interest has been put into the use of electromagnetic fields. This study tests the hypothesis that ultra-weak electromagnetic fields with a specific wave pattern (PEMF = pulsed electro magnetic fields) can alleviate the symptoms of depression.', 'detailedDescription': 'In this study, a patient with treatment resistant depression, as defined by Harold Sackeim, is subjected to 5 weeks of treatment with active or sham PEMF treatment for 30 minutes on every working day. The pharmacological treatment for depression is maintained unaltered throughout the study. Depression severity is measured at the beginning of the study and at each weekly visit. Side effects are closely observed. The ability to concentrate is measured by the AQT test (Alzheimers Quick Test). Personality is assessed by use of the SCID-II-instrument (DSM-IV axis II).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major depression\n* Treatment resistance\n* Age above 18 years\n* Hamilton 17 item score above 13\n* Unaltered pharmacological treatment in last 4 weeks\n\nExclusion Criteria:\n\n* Psychotic disorder\n* Mental retardation\n* Suicidality\n* Earlier treatment with PEMF\n* Abuse of alcohol or other substances\n* Patient not able to come to appointed visits\n* Antisocial, borderline or schizotypic personality disorder\n* Women lactating or pregnant\n* Unreliable contraception'}, 'identificationModule': {'nctId': 'NCT00287703', 'briefTitle': 'Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression', 'organization': {'class': 'OTHER', 'fullName': 'Hillerod Hospital, Denmark'}, 'officialTitle': 'Pulsed Electro Magnetic Fields (PEMF) Treatment in Patients With Treatment-Resistant Major Depression in Ongoing Pharmacological Treatment of Depression', 'orgStudyIdInfo': {'id': 'Final version 26 Oktober 2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Active Pulsating Electro Magnetic Fields (PEMF) treatment', 'interventionNames': ['Device: Pulsating Electro-Magnetic Fields']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': '5 days a week for 5 weeks for 30 minutes Sham PEMF', 'interventionNames': ['Device: Pulsating Electro-Magnetic Fields sham']}], 'interventions': [{'name': 'Pulsating Electro-Magnetic Fields', 'type': 'DEVICE', 'description': '5 days a week for 5 weeks 30 minutes', 'armGroupLabels': ['1']}, {'name': 'Pulsating Electro-Magnetic Fields sham', 'type': 'DEVICE', 'description': 'sham PEMF', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Municipality of Frederiksberg', 'country': 'Denmark', 'facility': 'Speciallægerne Falkoner Allé'}], 'overallOfficials': [{'name': 'Klaus Martiny, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychiatric Research Unit Fredericksburg General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Lundbeckfoundation', 'class': 'UNKNOWN'}, {'name': 'Biofields', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Klaus Martiny', 'oldOrganization': 'Psychiatric Research Unit, Hillerod Hospital'}}}}