A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Bipolar Depression
Sponsored by University of California, Davis
About this trial
Last updated 7 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 15 years ago
What is this trial about?
What are the participation requirements?
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