Phase
Condition
Depression (Major/severe)
Depression
Bipolar Disorder
Treatment
iTBS repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Are a male or female aged 18 to 70 years.
Have a diagnosis of Bipolar Disorder with a current ongoing episode of depression.
Are not currently experiencing a mania.
Have failed to achieve a clinical response or have been unable to tolerate anadequate dose of at least one of the medications used for treating Bipolardepression
Are taking an anti-manic agent (lithium or valproate) or an atypical antipsychotic (quetiapine, lurasidone, aripiprazole, ziprasidone, risperidone, olanzapine), or acombination of the above, or a combination of any of them with lamotrigine 100-400mg daily. Lamotrigine alone for bipolar II disorder is permitted.
current medications have been at a stable dose in the 2 weeks prior to randomization
Are capable of understanding, consenting to, and complying with the requirements ofthe study
Exclusion
Exclusion criteria:
Have an alcohol or substance abuse or dependence within the last 3 months.
Are at a significant risk of harm to themselves or others
Are pregnant or planning on becoming pregnant in near future or lactating.
Have a personal or family history of seizures.
Have a history of unstable or inadequately treated medical illnesses, includingmoderate to severe brain injury or head trauma.
Have a primary diagnosis of other psychiatric disorders (other than Bipolar) orpersonality disorders that are of primary concern and causing greater impairmentother than bipolar disorder.
are currently taking more than 3 of the antipsychotics.
Have failed a course of ECT in the current episode.
History of non-response to rTMS treatment.
If participating in psychotherapy, you must have been in stable treatment for atleast 3 months prior to entry into the study,
Currently (or in the last 4 weeks) taking more than 2 mg daily (or equivalent) oflorazepam or any dose of medication for seizures
Have a pacemaker, or an 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.
Have a non-correctable clinically significant sensory impairment (i.e., cannot hearwell enough to cooperate with interview).
Study Design
Study Description
Connect with a study center
Dr. Alexander McGirr
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
Djavad Mowfaghian Centre for Brain Heath
Vancouver, British Columbia V6T 1Z3
CanadaSite Not Available

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