Testing iTBS Stimulation against a placebo for bipolar depression

Inclusion

• +Age 18-65;
• +no increase or initiation of psychotropic medication with intention of treating depressive symptoms in the 4 weeks prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →. This excludes targeted treatment of insomnia with trazodone, melatonin, low-dose doxepin \[3-6mg\], low-dose benzodiazepines \[≤2mg lorazepam daily equivalent\], non-benzodiazepine benzodiazepine receptor agonists, or orexin antagonists;
• +The participant must meet all of the inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → to eligible for this clinical trialInterventional studyA study where participants are given something to see what happens.Read more →:
• +Must be deemed to have capacity to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
• +Must be an outpatient
• +Have a DSM 5 diagnosis of bipolar disorder (type I or II), current episode depressed confirmed by Mini-International Neuropsychiatric Interview version 7.0.2 (MINI);
• +failure to achieve a clinical response to ≥1 adequate treatment trial for bipolar depression based on the Antidepressant Treatment History Form - Short Form (ATHF-SF) OR unable to tolerate at least 2 separate inadequate treatment trials for bipolar depression;43
• +moderately severe depression with a score ≥ 15 on the PHQ-9;44
• +not currently experiencing a mixed or manic episode (YMRS ≤10);
• +able to adhere to the treatment schedule;
• +pass the TMS adult safety screening questionnaire.45
• +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
• +An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
• +have a concomitant major unstable medical illness;
• +have active suicidal intent (assessed during HRSD-17 Item 3 and SSRS as imminent intent to act on specific plan, confirmed by psychiatric staff);
• +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 received any rTMS before due to potential to compromise blinding of treatment allocation;
• +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;
• +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;
• +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 screening, 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).
• +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;