Phase
Condition
Depression (Major/severe)
Affective Disorders
Depression
Treatment
Transcranial Magnetic Stimulation (TMS) - Standard maintenance rTMS:
Transcranial Magnetic Stimulation (TMS) - Clustered maintenance rTMS:
Transcranial Magnetic Stimulation (TMS) -- Sham maintenance rTMS
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
They met criteria for a DSM-5 diagnosis of a Major Depressive Episode (MDE)during the index episode of depression for which they have received an acuterTMS treatment course.
Meet criteria for either response or remission from their initial depressiveillness. The MINI assessment timeline will be adjusted to allow scoring ofillness symptoms prior to rTMS response. Response to acute course of treatmentis defined as either a MADRS score of <7, or a MADRS score of 7-19, plusevidence of having met response criteria on either the MADRS or anotherstructured depression rating scale. The response is defined as a >50% reductionin the total score from the start to the end of treatment.
Their initial rTMS treatment course must have consisted of at least 15 rTMStreatment sessions.
People between the ages of 18 and 80 at the time of screening. A writtenstatement from the referring physician will be required to confirm that theparticipant demonstrates the capacity to consent.
Able to read, understand, and provide written, dated informed consent prior toscreening. Proficiency in English sufficient to complete questionnaires /follow instructions during TMS-EEG assessments and iTBS interventions. Statedwillingness to comply with all study procedures, including availability for theduration of the study, and to communicate with study personnel about adverseevents and other clinically important information.
In good general health, as evidenced by medical history. 7. Agreement to adhereto Lifestyle Considerations throughout study duration. 8. If a person ofchild-bearing potential is: must take a pregnancy test at the screening visit,with results confirmed as negative by study staff
Exclusion
Exclusion Criteria:
Pregnancy 2. History of or current psychotic disorder or depression withpsychotic features 3. Severe borderline personality disorder based on clinicalassessment. 4. Diagnosis of Intellectual Disability or Autism Spectrum Disorder
Current moderate or severe substance use disorder or demonstrating signs ofacute substance withdrawal 6. Clinically significant suicidal ideation withplan 7. Any history of ECT (greater than 8 sessions) without a clinicalmeaningful response in the current episode.
Recent (during the current depressive episode) or concurrent use ofrapid-acting antidepressant agent (i.e., ketamine or a course of ECT) in thelast 30 days 9. History of significant neurologic disease, including dementia,Parkinson's or Huntington's disease, brain tumor, seizure disorder, subduralhematoma, multiple sclerosis, or history of significant head trauma 10.Untreated or insufficiently treated endocrine disorder. 11. Contraindicationsto receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
Treatment with an investigational drug or other intervention within thestudy period 13. Unstable symptoms between screening and baseline as defined bya ≥ 30% change in MADRS score.
Require a benzodiazepine with a dose > lorazepam 2 mg/day or equivalent or anyanticonvulsant (with the exception of Gabapentin).
Study Design
Connect with a study center
Australian National University
Canberra, Australian Capital Territory 2601
AustraliaActive - Recruiting
University of California, San Diego
San Diego, California 92127
United StatesActive - Recruiting
Weill Cornell Medicine
New York, New York 10065
United StatesActive - Recruiting

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