Theta-Burst Stimulation for Bipolar Depression

Exclusion Criteria

• •An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
• •1. have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months;
• •2. have a concomitant major unstable medical illness;
• •3. have active suicidal intent (assessed during HRSD-17 Item 3 and SSRS as imminent intent to act on specific plan, confirmed by psychiatric staff);
• •4. are pregnant or intend to get pregnant during the study;
• •5. have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder;
• •6. have psychotic symptoms within the current episode;
• •7. have a MINI anxiety disorder, trauma-related disorder, obsessive compulsive disorder, or personality disorder assessed by a study investigator to be primary and/or causing greater impairment than BD-DE;
• •8. failure of an adequate acute course of ECT as defined by ATHF-SF during the current episode;
• •9. have received any rTMS before due to potential to compromise blinding of treatment allocation;
• •10. 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.);
• •11. 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;
• •12. are participating in psychotherapy for less than 3 months. Patients will be permitted if they have been in stable treatment for at least 3 months prior to study entry, with no anticipated change in the frequency of therapeutic sessions, or focus of therapeutic sessions over the duration of the study;
• •13. are currently taking lorazepam \>2 mg daily (or equivalent) due to the potential to limit rTMS efficacy;
• •14. are currently taking any dose of an anticonvulsant due to the potential to limit rTMS efficacy. If anticonvulsants have been discontinued prior to screening, at least 5 half-lives have elapsed until screening to allow sufficient drug clearance;
• •15. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).