A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Bipolar Depression

Not Applicable

Completed

Interventions: Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.

Brief Summary: This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will benefit patients with bipolar depression safely. Based on published studies, this study hypothesizes that rTMS on the left dorsal prefrontal lobe will improve symptoms in some patients who have failed at least two medications.

Detailed Description: Candidate with bipolar depression will be screened after signing informed consent. Those who meet the selection criteria will be treated with daily rTMS for 3 weeks and be followed-up at 2 weeks. Participants will keep their ongoing medication unless a medication significantly increases the possibility of seizure. They must be on the same dose of antidepressant medication for least 4 weeks without improvement of symptoms before being recruited into the study. Mood and other observed mental status will be measured by standard psychological scales.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Rapid cycling bipolar or mixed episode of mood disorder by definition of current DSM criteria
Substantial risk of suicide during the screening period that requires inpatient care
Presence of psychosis
Dual diagnosis of other primary, currently clinically significant severe mental disorders
History of other significant neurological diseases, such as seizure disorder, stroke, brain tumors, abnormalities in the blood vessels in brain, dementia, Parkinson's disease, Huntington's chorea or multiple sclerosis
History of any medical event that may increase the risk of having seizure, such as head trauma with unconsciousness for more than 5 minutes or a family history of seizure
Significant medical complications that may deteriorate during the trial or have increased likelihood of danger consequences
Patients who are pregnant or intend to become pregnant during the study period
Any metallic prosthesis in head, neck or upper body (including cardiac pace maker) that cannot be safely removed during treatment
Current Vagus Nerve Stimulation (VNS) treatment or Electroconvulsive Therapy (ECT) treatment, or with history of failed ECT treatment
Patient's Motor Threshold for TMS cannot be detected
Significant side effects which are intolerable during the screening or any later stage of the trial
Started psychotherapy within the previous 8 weeks or foreseeable psychotherapy will be started or changed in 6 weeks

Arm && Interventions

Group	Intervention	Description
rTMS treatment	Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.	Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression (HAM-D)	5 weeks	Scored Questionnaire 0-52, A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression. The higher score means more severe depression.

Secondary Outcome Measures

Name	Time	Method
Inventory of Depressive Symptomatology	5 weeks	Self reported depression scale range 0-84. Questionnaire administered at 1,2, and 3 weeks (end of treatment). We also did a 5 week follow-up. The higher scores indicate greater or more severe depression.