Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-20 @ 1:53 PM
Study NCT ID:
NCT01849367
Status:
COMPLETED
Last Update Posted:
2015-09-17
First Post:
2013-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Bilateral tDCS for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-15', 'studyFirstSubmitDate': '2013-05-05', 'studyFirstSubmitQcDate': '2013-05-07', 'lastUpdatePostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery Asberg Depression Rating Scale for Depression (MADRS)', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. Mood, cognitive test performance and biomarkers will be measured during the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant meets criteria for a DSM-IV Major Depressive episode.\n2. MADRS score of 20 or more.\n\nExclusion Criteria:\n\n1. Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.\n2. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).\n3. Inadequate response to ECT in the current episode of depression.\n4. Participant is on regular benzodiazepine medication which is not clinically appropriate to discontinue.\n5. Participant requires a rapid clinical response due to inanition, psychosis or high suicide risk.\n6. Neurological disorder or insult, e.g., recent stroke (CVA), which places participant at risk of seizure or neuronal damage with tDCS.\n7. Participant has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.\n8. Female participant who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).\n9. Participants who are not fluent in English will not be included in the trial for safety reasons.'}, 'identificationModule': {'nctId': 'NCT01849367', 'briefTitle': 'Trial of Bilateral tDCS for Depression', 'organization': {'class': 'OTHER', 'fullName': 'The University of New South Wales'}, 'orgStudyIdInfo': {'id': 'HC13052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active tDCS (1)', 'interventionNames': ['Device: Eldith Neuroconn tDCS device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active tDCS (2)', 'interventionNames': ['Device: Eldith Neuroconn tDCS device']}], 'interventions': [{'name': 'Eldith Neuroconn tDCS device', 'type': 'DEVICE', 'armGroupLabels': ['Active tDCS (1)', 'Active tDCS (2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Black Dog Institute / University of New South Wales', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of New South Wales', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Colleen Loo', 'investigatorAffiliation': 'The University of New South Wales'}}}}