Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 11:46 PM
Study NCT ID:
NCT01502033
Status:
COMPLETED
Last Update Posted:
2016-04-22
First Post:
2011-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'croarkin.paul@mayo.edu', 'phone': '(507) 293-2557', 'title': 'Dr. Paul Croarkin', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Please note that clinical results must be interpreted with caution due to small sample size and study design.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Open Label Active Treatment', 'description': 'All participants had unblinded treatment', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'scalp pain', 'notes': 'One participant had scalp pain with the initial session and discontinued treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'notes': 'Anxiety (related to school expectations)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Anxiety'}, {'term': 'Depression', 'notes': 'Worsening depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Magnetic Stimulation', 'description': "Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.\n\nTranscranial Magnetic Stimulation"}], 'classes': [{'categories': [{'measurements': [{'value': '41.8', 'spread': '13.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days of Treatment 30 or Last Treatment', 'description': "The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Active Treatment', 'description': 'All participants had unblended treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 5 days of Treatment 30 or Last Treatment', 'description': "The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= normal, not ill at all; 7= among the most ill patients; larger number indicates greater severity of symptoms or worse outcome).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Clinical Global Impression - Improvement (CGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Magnetic Stimulation', 'description': "Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.\n\nTranscranial Magnetic Stimulation: 30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment"}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 5 days of 30 treatments or after last treatment in case of early withdrawal', 'description': "The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates improvment of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= very much improved, 7=very much worse) larger number indicates greater severity of symptoms or worse outcome).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transcranial Magnetic Stimulation', 'description': "Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.\n\nTranscranial Magnetic Stimulation"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Milestone (10 participants) met.', 'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Milestone (10 participants) met', 'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': '1 participant had scalp discomfort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': '1 participant had worsening depression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': '1 participant went back to school', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '10 participants recruited(and enrolled) from the Mayo Clinic Child and Adolescent Mood Disorders Clinic.', 'preAssignmentDetails': 'Participants were maintained on stable dosage of antidepressant medication for 4 weeks prior to enrollment and rTMS treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Transcranial Magnetic Stimulation', 'description': "Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.\n\nTranscranial Magnetic Stimulation"}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'spread': '1.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Children's Depression Rating Scale Revised", 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '8.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'description': 'Range of total score is 17-113 Total score of 40 or higher indicates moderate to severe depression (higher scores indicate increased severity of depressive symptoms).\n\nA score below 40 indicates mild or minimal depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2011-12-27', 'resultsFirstSubmitDate': '2015-08-06', 'studyFirstSubmitQcDate': '2011-12-28', 'lastUpdatePostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-20', 'studyFirstPostDateStruct': {'date': '2011-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)", 'timeFrame': '5 days of Treatment 30 or Last Treatment', 'description': "The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items."}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)', 'timeFrame': 'Within 5 days of Treatment 30 or Last Treatment', 'description': "The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= normal, not ill at all; 7= among the most ill patients; larger number indicates greater severity of symptoms or worse outcome)."}, {'measure': 'The Clinical Global Impression - Improvement (CGI-I)', 'timeFrame': 'Within 5 days of 30 treatments or after last treatment in case of early withdrawal', 'description': "The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates improvment of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= very much improved, 7=very much worse) larger number indicates greater severity of symptoms or worse outcome)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adolescent Depression', 'Transcranial Magnetic Stimulation'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '24376426', 'type': 'BACKGROUND', 'citation': 'Wall CA, Croarkin PE, McClintock SM, Murphy LL, Bandel LA, Sim LA, Sampson SM. Neurocognitive effects of repetitive transcranial magnetic stimulation in adolescents with major depressive disorder. Front Psychiatry. 2013 Dec 12;4:165. doi: 10.3389/fpsyt.2013.00165. eCollection 2013.'}, {'pmid': '31634515', 'type': 'DERIVED', 'citation': 'Sonmez AI, Kucuker MU, Lewis CP, Kolla BP, Doruk Camsari D, Vande Voort JL, Schak KM, Kung S, Croarkin PE. Improvement in hypersomnia with high frequency repetitive transcranial magnetic stimulation in depressed adolescents: Preliminary evidence from an open-label study. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Mar 8;97:109763. doi: 10.1016/j.pnpbp.2019.109763. Epub 2019 Oct 18.'}, {'pmid': '26849202', 'type': 'DERIVED', 'citation': 'Wall CA, Croarkin PE, Maroney-Smith MJ, Haugen LM, Baruth JM, Frye MA, Sampson SM, Port JD. Magnetic Resonance Imaging-Guided, Open-Label, High-Frequency Repetitive Transcranial Magnetic Stimulation for Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2016 Sep;26(7):582-9. doi: 10.1089/cap.2015.0217. Epub 2016 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'This research study aims to test the safety and effectiveness of repetitive transcranial magnetic stimulation (rTMS) on teens with depression. The study also seeks to understand how rTMS treatment affects the neurobiology of teens with depression.', 'detailedDescription': 'This study aims to:\n\n1. Evaluate the antidepressant effect and safety of rTMS in adolescents meeting criteria for major depressive disorder, single or recurrent episode.\n2. Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla (3T), the regional specificity \\[anterior cingulate (AC) vs. left dorsolateral prefrontal cortex (L-DLPFC)\\] of cerebral metabolites (glutamate and glutamine) in adolescent depression and study whether glutamine resonances are associated with response or remission of clinical depressive symptoms when rTMS is used to treat adolescent depression.\n3. Evaluate the accuracy of an efficient method for locating the F3 position (i.e., L-DLPFC) through comparison with magnetic resonance imaging (MRI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features\n* Pretreatment CDRS-R Raw score ≥ 40\n* Age is at least 13 and less than 19 years\n* Ongoing, stable dose antidepressant therapy for at least 6 weeks to include the following antidepressants (with dosing range):\n\n * Celexa (citalopram hydrobromide) - 10 to 60mg\n * Cymbalta (duloxetine) - 40mg to 120mg\n * Desyrel (trazodone HCl) - 12.5mg to 150mg\n * Effexor (venlafaxine HCl) - 37.5mg to 300mg\n * Luvox (fluvoxamine maleate) - 25mg to 200mg\n * Lexapro (escitalopram oxalate) - 10mg to 40mg\n * Paxil (paroxetine HCl) - 10mg to 50mg\n * Pristiq (desvenlafaxine) - 50mg to 100mg\n * Prozac (fluoxetine HCl) - 10mg to 80mg\n * Remeron (mirtazapine) - 7.5mg to 45mg\n * Zoloft (sertraline HCl) - 25mg to 200mg\n* Subjects able to attend at least 31 study visits at Mayo Clinic - Rochester\n* Willing to provide informed assent (adolescent) and informed consent (family)\n\nExclusion Criteria:\n\n* Subjects currently on stimulant, antipsychotic, bupropion or tricyclic antidepressant medications.\n* Prior rTMS, vagus nerve stimulation (VNS) or electroconvulsive therapy (ECT)\n* Contraindication to MRI\n* Contraindication to rTMS (history of neurological disorder such as seizures, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \\>15 minutes, history of stroke, family history of epilepsy, intracardiac lines, Anticoagulant, immune suppressive and/or chemotherapy, or those who received any of these therapies within 3 months before enrollment in the study Unstable medication conditions such as hematological or infectious (e.g., human immunodeficiency virus-HIV) disorders, implanted electronic device, metal in the head, or pregnancy)\n* History of schizophrenia, schizoaffective disorder, other \\[non mood disorder\\] psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), bipolar disorder, psychotic features in this or previous episodes, amnestic disorder, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder\n* History of autoimmune, endocrine, viral, or vascular disorder.\n* Unstable cardiac disease, uncontrolled hypertension, or sleep apnea\n* Active suicidal intent or plan, or history of attempt within the past 6 months'}, 'identificationModule': {'nctId': 'NCT01502033', 'briefTitle': 'Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'An Open-Label Eight-Week Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents: Mechanisms of Response', 'orgStudyIdInfo': {'id': '11-004500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial Magnetic Stimulation', 'description': "Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.", 'interventionNames': ['Device: Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'otherNames': ['NeuroStar'], 'description': '30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment', 'armGroupLabels': ['Transcranial Magnetic Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Paul E Croarkin, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paul E. Croarkin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Child and Adolescent Psychiatry', 'investigatorFullName': 'Paul E. Croarkin', 'investigatorAffiliation': 'Mayo Clinic'}}}}