Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-04-08 @ 2:21 PM
Study NCT ID:
NCT01890356
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2013-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance Transcranial Electrical Stimulation for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-25', 'studyFirstSubmitDate': '2013-06-26', 'studyFirstSubmitQcDate': '2013-06-26', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery Asberg Depression Rating Scale for Depression (MADRS)', 'timeFrame': '9 months'}]}, 'conditionsModule': {'keywords': ['Depression', 'Treatment', 'Transcranial electrical stimulation', 'Maintenance'], 'conditions': ['Major Depressive Disorder', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'Transcranial electrical stimulation (TES) techniques offer a novel treatment approach for depression and have shown promising efficacy. However, there is no published data to date on their effectiveness as a maintenance treatment. This study will investigate ways of using TES as a maintenance treatment to prevent relapse in depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants will be ≥ 18 years old.\n* Participants must have experienced a significant clinical response, defined as ≥ 50% decrease from baseline scores on the Montgomery Asberg Depression Rating Scale (MADRS).\n\nExclusion Criteria:\n\n* Inadequate response to acute trial of TES.\n* Suicidality.\n* Clinically defined neurological disorder or insult.\n* Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.\n* Pregnancy (women of childbearing age will be asked to undergo a urine pregnancy test prior to starting the study).\n* Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.\n* Treatment for depression is changed during months 3-9 of the trial.'}, 'identificationModule': {'nctId': 'NCT01890356', 'briefTitle': 'Maintenance Transcranial Electrical Stimulation for Depression', 'organization': {'class': 'OTHER', 'fullName': 'The University of New South Wales'}, 'officialTitle': 'A Study of Transcranial Electrical Stimulation (TES) as a Maintenance Treatment for Depression', 'orgStudyIdInfo': {'id': 'HC12499'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial electrical stimulation', 'interventionNames': ['Device: Transcranial electrical stimulation']}], 'interventions': [{'name': 'Transcranial electrical stimulation', 'type': 'DEVICE', 'armGroupLabels': ['Transcranial electrical stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Randwick, Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Black Dog Institute / University of New South Wales'}], 'overallOfficials': [{'name': 'Colleen Loo, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New South Wales'}]}, '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'}}}}