Phase
Condition
Borderline Personality Disorder
Depression
Schizotypal Personality Disorder (Spd)
Treatment
N/AClinical Study ID
Ages 18-65 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Are voluntary and competent to consent to treatment.
Have met DSM-5 diagnostic criteria for borderline personality disorder, AND
Have met DSM-5 diagnostic criteria of MDD single or recurrent, or Bipolar Disorderwith a current Major Depressive Episode at the time of their consultation for rTMS.
Are females 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 of > 3 in the currentepisode OR have been unable to tolerate at least 2 separate trials of antidepressantsof inadequate dose and duration (ATHF 1 or 2)
have a score ≥18 on the HRSD-17 item
able to adhere to the treatment schedule
pass the TMS safety-screening questionnaire
have normal thyroid functioning and no clinically significant abnormalities on CBC, onpre-study blood work.
are already under the care of a psychiatrist who agrees to provide continuity of allnon-rTMS aspects of care throughout the study.
Exclusion
Exclusion Criteria:
Pregnancy
A lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis ofschizophrenia, schizoaffective disorder, schizophreniform disorder, delusionaldisorder, or current psychotic symptoms
A MINI diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder,social anxiety disorder, panic disorder), or dysthymia, assessed by a studyinvestigator to be primary and causing greater impairment than current MDDcurrent MDDor BPD
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 induced byECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis,significant head trauma with loss of consciousness for greater than or equal to 5minutes.
Have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlearimplants, or electrodes) or any other metal object within or near the head, excludingthe 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 the frequencyof therapeutic sessions, or the therapeutic focus over the duration of the study
Medication: currently (or in the last 4 weeks) taking more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMSefficacy. Medication regimen should be stable for at least 4 weeks prior to first rTMStreatment.
Alcohol or substance use: severe substance use disorder (based on DSM-5 diagnosticcriteria) assessed by the study investigator to be primary and causing greaterimpairment than MDD or BPD.
Non-correctable clinically significant sensory impairment (i.e., cannot hear wellenough to cooperate with interview).
Serious suicide attempt that necessitate medical intervention during the last 3months.
Study Design
Study Description
Connect with a study center
Toronto Western Hospital
Toronto, Ontario M5T2S8
CanadaSite Not Available

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