Phase
Condition
Depression
Depression (Major/severe)
Affective Disorders
Treatment
Sham iTBS
Active iTBS
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
are outpatients
are voluntary and competent to consent to treatment
have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis ofMDD, single or recurrent
are between the ages of 18 and 65
have failed to achieve a clinical response to an adequate dose of an antidepressantbased on an Antidepressant Treatment History Form (ATHF) score for thatantidepressant trial of > 3 in the current episode OR have been unable to tolerateat least 2 separate trials of antidepressants of inadequate dose and duration (ATHFscore of 1 or 2 on those 2 separate antidepressants)
have a score > 18 on the HRSD-17 item
have had no increase or initiation of any psychotropic medication in the 4 weeksprior to screening
able to adhere to the treatment schedule
Pass the TMS adult safety screening (TASS) questionnaire
have normal thyroid functioning based on pre-study blood work.
Exclusion
Exclusion Criteria:
have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis ofsubstance dependence or abuse within the last 3 months
have a concomitant major unstable medical illness, cardiac pacemaker or implantedmedication pump
have active suicidal intent
are pregnant
have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis ofbipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniformdisorder, delusional disorder, or current psychotic symptoms
have a MINI diagnosis of obsessive compulsive disorder, post-traumatic stressdisorder (current or within the last year), anxiety disorder (generalized anxietydisorder, social anxiety disorder, panic disorder), or dysthymia, that is assessedby a study investigator to be primary and causing greater impairment than MDD
have a diagnosis of any personality disorder, and assessed by a study investigatorto be primary and causing greater impairment than MDD
have failed a course of ECT in the current episode or previous episode
have received rTMS for any previous indication due to the potential compromise ofsubject blinding
have any significant neurological disorder or insult including, but not limited to:any condition likely to be associated with increased intracranial pressure, spaceoccupying brain lesion, any history of seizure except those therapeutically inducedby ECT or a febrile seizure of infancy, cerebral aneurysm, Parkinson's disease,Huntington's chorea, multiple sclerosis, significant head trauma with loss ofconsciousness for greater than 5 minutes
have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlearimplants, or electrodes) or any other metal object within or near the head,excluding the mouth, that cannot be safely removed
if participating in psychotherapy, must have been in stable treatment for at least 3months prior to entry into the study, with no anticipation of change in thefrequency of therapeutic sessions, or the therapeutic focus over the duration of thestudy
clinically significant laboratory abnormality, in the opinion of the one of theprincipal investigators or study physicians
currently take more than lorazepam 2 mg daily (or equivalent) or any dose of ananticonvulsant due to the potential to limit rTMS efficacy
non-correctable clinically significant sensory impairment (i.e., cannot hear wellenough to cooperate with interview).
Study Design
Study Description
Connect with a study center
University of British Columbia
Vancouver, British Columbia V6T2A1
CanadaSite Not Available
CAMH
Toronto, Ontario M6J1H4
CanadaSite Not Available

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