Bipolar Disorder (BPD) Clinical Trials

• The condition under study: Patients who are diagnosed by Bipolar I or II, current episode depressed according to the ICD-10 diagnostic criteria (F31.3, F31.4, F31.5, F31.81) or treatment resistant depression defined below who require a rapid response due to the severity of their psychiatric or medical condition. ICD-10 Diagnostic Criteria for Bipolar Depression is as follows: A disorder characterized by two or more episodes in which the patient's mood and activity levels are significantly disturbed, this disturbance consisting on some occasions of an elevation of mood and increased energy and activity (hypomania or mania) and on others of a lowering of mood and decreased energy and activity (depression). Repeated episodes of hypomania or mania only are classified as bipolar. The patient is currently depressed, as in a depressive episode and has had at least one authenticated hypomanic, manic, or mixed affective episode in the past. Subjects with treatment resistant depression and have severe depression will be enrolled to the study. Severe depression will be defined as Hamilton Depression Severity Rating Scale score above 19 and also treatment resistance is described as a lack of clinically meaningful improvement in depressive symptoms after treatment with at least two different oral antidepressant medications as monotherapy, taken at adequate doses for adequate duration (at least 6 weeks) for their current episode of depression. The previous oral antidepressants could be from the same or different drug classes, which could include SSRIs, SNRIs, tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), or any other oral antidepressants (FDA, 2019). Since its development in 1960 by Dr. Max Hamilton of the University of Leeds, England, Hamilton Depression Severity Rating Scale has been widely used in clinical practice and become a standard in pharmaceutical trials

• Both males and females any race and ethnic group.

• Age range between 22-85 years old.

• Ability to provide informed consent or assent.

• Ability to adhere to the study procedures.

• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one week after the end of ECT/TMS administration. Of note, ECT is indicated in depression during pregnancy and has been safely used for decades but MST's effects on fetus are still unknown

• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

• Has sufficient English in completing self-rated scales.

• Good general health evidenced by obtained medical clearance before the procedures from another provider.

• On a stable drug regimen of psychotropic medication for at least 6 weeks at the time of entry into the study. Medication changes can be made during patient's study participation but would be limited to the clinical judgment of the PI.