Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT02383693
Status:
UNKNOWN
Last Update Posted:
2015-03-09
First Post:
2015-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-03', 'studyFirstSubmitDate': '2015-02-24', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "'Hamilton depression rating scale (HDRS)", 'timeFrame': 'one years', 'description': 'The efficacy variables included the HDRS-17 item scores, the CGI changes, the Visual Analog Scale (VAS), the Beck Depression Inventory (BDI) and the Hospital Anxiety Depression (HAD).\n\nThe subjective assessment performed with the VAS consisted of a 100-mm horizontal line oriented with anchors placed at both poles for reassured, sadness, anxiety, and relief. The patients are asked to mark a spot along this line that best indicated the magnitude of their state for each item.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'Repetitive Transcranial Magnetic Stimulation', 'tolerability', 'efficiency', 'TMS', 'refractory'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'number of center : 1\n\n* duration of study : 24 months\n* recruitement time : 23 months\n* Aim :Principal\n\nEvaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients.\n\nSecondary\n\nEvaluate the impact of rTMS on cognitive functions.', 'detailedDescription': 'The study involves 40 TRD patients in a single site trial which consisted of two phases: an acute phase (phase I) in which all the participants receive active high-frequency stimulation during 4 blocks of five consecutive working days (Monday to Friday) in an open-label design and a maintenance phase (phase II) in which responders (\\> 49% HDRS-17 reduction from baseline) at the end of the phase I are randomized in two arms with sham or active high-frequency rTMS maintenance treatment for the eleven following months. The rhythm of rTMS sessions in this maintenance phase is gradually reduced as follows: 3 sessions per week for 2 weeks, 2 session per week for the 2 following weeks, 1 session per week the third (M3) and fourth month (M4) and then 1 session every fortnight the last eight months (M5 to M12).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TRD stage I Thase-Rush\n* HDRS + or = 18\n* Patients age 18 to 70 years.\n* Negative pregnancy test and contraception for women.\n* Informed Consent\n\nExclusion Criteria:\n\n* Patient was treated with mood stabilizer in the previous week\n* Other disorder on axis I of the DSM IV than depressive disorder.\n* Patient with an addiction problem other than tobacco and caféine\n* antécedent of Epilepsy ,other neurological pathology and intra cranial metal diapositive or pacemaker\n* Previous history of head trauma the previous two years.\n* intracranial hypertension.\n* not affiliated to the social security Patient\n* patient under constraint hospitalisation\n* Under legal protection measure'}, 'identificationModule': {'nctId': 'NCT02383693', 'acronym': 'TMS/DEP', 'briefTitle': 'Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre hospitalier de Ville-Evrard, France'}, 'officialTitle': 'Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study', 'orgStudyIdInfo': {'id': '2007-A00244-49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'repetitive transcranial magnetic stimulation', 'description': 'Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks', 'interventionNames': ['Device: Repetitive Transcranial Magnetic Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham comparator', 'description': 'Placebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks', 'interventionNames': ['Device: Repetitive Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'Repetitive Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'otherNames': ['TMS'], 'description': 'Repetitive Transcranial Magnetic Stimulation', 'armGroupLabels': ['Sham comparator', 'repetitive transcranial magnetic stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93330', 'city': 'Neuilly-sur-Marne', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arezki OURRAD, BIOLOGISTE', 'role': 'CONTACT', 'phone': '0143093232'}], 'facility': 'Unité de Recherche Clinique', 'geoPoint': {'lat': 48.85373, 'lon': 2.54903}}], 'centralContacts': [{'name': 'Dominique januel, MD.Phd', 'role': 'CONTACT', 'email': 'domjanuel@gmail.com', 'phone': '0143093232'}], 'overallOfficials': [{'name': 'Rene BENADHIRA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'E.P.S ville Evrard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre hospitalier de Ville-Evrard, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'René BENADHIRA', 'investigatorAffiliation': 'Centre hospitalier de Ville-Evrard, France'}}}}