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

University of California (UC) Davis

Status

Completed

Conditions

Major Depression

Bipolar Disorder

Depression

Mood Disorder

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00699218

200715749

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

bipolar I or II patients, currently in a depression episode
Patient must have failed at least 2 medication
Score of 21-item Hamilton Rating Scale for Depression (HAM-D)

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