Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT00370058
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2006-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Influence of Electroconvulsive Therapy (ECT) on Homocysteine Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D019305', 'term': 'Epilepsy, Rolandic'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2006-08-29', 'studyFirstSubmitQcDate': '2006-08-29', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Homocysteine serum levels'}], 'secondaryOutcomes': [{'measure': 'Cognitive functioning (e.g. concentration, memory tasks, etc.)'}, {'measure': 'Depressive symptomatology'}, {'measure': 'Measures of Seizure quality (duration, threshold, postictal suppression index, ...)'}]}, 'conditionsModule': {'keywords': ['ect', 'depression', 'homocysteine', 'mthfr genotype'], 'conditions': ['Depressive Disorder, Major']}, 'descriptionModule': {'briefSummary': 'Elevated homocysteine levels are associated with depression and cognitive impairment. When depression ameliorates due to treatment, homocysteine serum levels often normalize. Aim of the present study is to investigate, whether repeated ECT treatment leads to changes in homocysteine levels and if these changes are associated with the occurrence of cognitive impairment after ECS.\n\n10 patients suffering from therapy-resistant depression shall be enrolled. Patients are treated with repeated ECT (three times the week). Before, directly after and one day after ECT treatment, blood samples are drawn and patients receive cognitive testing. Depressive symptomatology is checked with different rating scales.', 'detailedDescription': 'BACKGROUND:\n\nElevated homocysteine levels have been found in depressive disorders. The modulating effects of homocysteine on glutamatergic neurotransmission have been discussed to be an underlying cause of depression and can also lead to cognitive impairment and may facilitate seizures. Electroconvulsive therapy is the most effective treatment for depression, but often leads to cognitive impairments.\n\nHYPOTHESIS:\n\nHomocysteine levels normalize during rECT. This normalization is associated with the clinical improvement of depression. Short term changes in homocysteine levels (i.e. increase directly after ECT) may explain the cognitive impairments of the patients.\n\nMETHOD:\n\n10 patients with therapy-resistant depressive disorder are to be enrolled into the trial. Patients are treated with rECT, two to three times a week. Blood withdrawal and psychometric analysis will be performed before, directly after and one day after ECT treatment 1,4,7,10,(13). Necessity of further treatment will be checked after the first 6 ECTs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Men and women aged 18 years or above\n* Diagnosis of major depressive disorder (according to DSM IV)\n* Secured therapy resistance (at least two trials with antidepressive medication of different classes for more then 4 weeks in adequate dosage)\n* Written, informed consent\n\nKey Exclusion Criteria:\n\n* Major neurological or other diseases\n* Current medication with antiepileptic drugs\n* History of major head trauma\n* Any medical condition not allowing anesthesia'}, 'identificationModule': {'nctId': 'NCT00370058', 'briefTitle': 'Study on the Influence of Electroconvulsive Therapy (ECT) on Homocysteine Levels', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Modulation of Homocysteine-Plasma Levels by ECT - Association With Clinical Response. A Pilot Study in Patients With Major Depression', 'orgStudyIdInfo': {'id': 'ECT and Homocysteine'}, 'secondaryIdInfos': [{'id': 'Homocystein'}, {'id': 'ECT'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ECT treatment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Stefan Bleich, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Erlangen-Nuremberg'}, {'name': 'Wolfgang Sperling, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Erlangen-Nürnberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}}}}