An Open Label Trial of TMS Therapy for Bipolar Depression

Inclusion Criteria- Phase II:

• Must be at least 18 years old.
• Must meet DSM-5 criteria for bipolar (either I or II) depression by clinical interview and M.I.N.I. The duration of the current depressive episode must be at least 4 weeks and no longer than 3 years in length.
• Should have a MADRS score of at least 20 at screening, an YMRS score of less than 12 and a CGI score of at least 4.
• Must have signed the informed consent document and have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel.
• Must be on a mood stabilizer acceptable to the study physician which is consistent with their diagnosis. The mood stabilizer must be at a stable dose for at least four days before starting TMS treatment.
• If female of childbearing potential, patients must
• have a negative urine pregnancy test at screening, and
• not be nursing or planning a pregnancy, and
• be on a medically acceptable method of birth control acceptable to the principal investigator.

Choices of contraception that meet the study requirements are

• Intrauterine device
• Hormonal contraception (estrogen-containing birth control pills, Vaginal ring, patch, injections or implants)
• Latex condom with spermicide
• Diaphragm with spermicide
• Cervical cap with spermicide

Females of childbearing potential who are abstinent can enroll in the study.

Exclusion Criteria- Phase II:

• May not be directly affiliated with Sheppard Pratt Clinical Research Programs or be immediate family of Research Programs personnel.
• Must not have another primary Axis I diagnosis.
• The subject must not have stopped an antidepressant less than two weeks before starting TMS treatment or unable to discontinue antidepressant therapy.
• Should have no previous history of psychosis or substance dependence or abuse within the six months prior to Screening
• Presence of an Axis II disorder felt by the investigator to potentially interfere with study compliance would exclude a potential participant.
• Should not have prior intolerance of TMS or significant lack of response to adequate trials of TMS.
• Should not have a lifetime history of lack of response to ECT or VNS.
• Should not have any medical condition likely to interfere with safe study participation.
• Women of child-bearing potential who are not using a medically accepted means of contraception when engaging in sexual intercourse are excluded, as well as women who are pregnant or breast-feeding.
• Positive urine screen for any substance of abuse will exclude a patient, with the exception of benzodiazepines. A satisfactory explanation in the opinion of the investigator along with a negative repeat screen prior to Visit 2 is possibly acceptable.
• Current suicide risk, as evidenced:
• It is the judgment of the investigator that the patient may be at risk for suicide
• The patient has rated a "yes" to question 4 or question 5 on the Screening C-SSRS
• The patient has attempted suicide within the past 12 months prior to Screening.
• History of head injury, epilepsy or seizure disorder, non-removable metallic implants or objects in or around the head.

Inclusion Criteria- Phase III Patients who meet MADRS criteria for response or remission will enter Phase III, the six month follow-up phase of the study.