Testing MagPro X100/R30 stimulator, Cool-B70 for bipolar depression depressed phase

Exclusion

• −have a concomitant major unstable medical illness;
• −have active suicidal intent;
• −have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder;
• −have psychotic symptoms within the current episode;
• −have a MINI anxiety disorder, trauma-related disorder, obsessive compulsive disorder, or personality disorder assessed by a study investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → to be primary and/or causing greater impairment than BD-DE;
• −failure of an adequate acute course of ECT as defined by ATHF-SF during the current episode;
• −have any clinically significant neurological disorder (e.g., recent major cerebrovascular accident), or any history of seizure except those therapeutically induced by ECT or with clear precipitant (e.g., febrile seizure of childhood, alcohol withdrawal, etc.);
• −have any intracranial implant (e.g., aneurysm clips, shunts, stimulators,) 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 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study;
• −have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
• −are currently taking lorazepam ≥2 mg daily (or equivalent) due to the potential to limit rTMS efficacy;
• −are currently taking, any dose of an anticonvulsant due to the potential to limit rTMS efficacy;
• −if anticonvulsants have been discontinued prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, at least 5 half-lives have elapsed until screening to allow sufficient drug clearance;
• −have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
• −participant was withdrawn from the TRIBE study due to safety concerns or at the discretion of the PI.
• −any history of substance use in the last 4 weeks which poses a safety concern to undergo rTMS as assessed by the PI's review of responses to the trial's 'Substance Use Screening Questions Form'.
• −are pregnant or intend to get pregnant during the study;
• −have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months;