A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment of Bipolar Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mood Disorder
- Sponsor
- University of California, Davis
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Hamilton Rating Scale for Depression (HAM-D)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Hamilton Rating Scale for Depression (HAM-D)
Time Frame: 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 Outcomes
- Inventory of Depressive Symptomatology(5 weeks)