Bipolar Disorder, Depression, Major Depression, Mood Disorder
Conditions
Keywords
Bipolar, Depression, TMS, repetitive Transcranial Magnetic Stimulation, treatment, Efficacy, Safety
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.
Interventions
DEVICEMagnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.
High frequency repetitive TMS given daily on weekdays for 3 weeks
Sponsors
National Alliance for Research on Schizophrenia and Depression
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Active rTMS treatment
Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.: High frequency repetitive TMS given daily on weekdays for 3 weeks | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 50 years |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 3 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Hamilton Rating Scale for Depression (HAM-D)
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.
Time frame: 5 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Hamilton Rating Scale for Depression (HAM-D) | Week 1 | 18.4 units on a scale | Standard Deviation 8.7 |
| Experimental | Hamilton Rating Scale for Depression (HAM-D) | Week 2 | 13.4 units on a scale | Standard Deviation 6.8 |
| Experimental | Hamilton Rating Scale for Depression (HAM-D) | Week 3 | 12.4 units on a scale | Standard Deviation 6.8 |
| Experimental | Hamilton Rating Scale for Depression (HAM-D) | Week 5 | 13.7 units on a scale | Standard Deviation 7.4 |
Secondary
Inventory of Depressive Symptomatology
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.
Time frame: 5 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Inventory of Depressive Symptomatology | Week 1 | 41.1 units on a scale | Standard Deviation 10.2 |
| Experimental | Inventory of Depressive Symptomatology | Week 2 | 34.3 units on a scale | Standard Deviation 15.5 |
| Experimental | Inventory of Depressive Symptomatology | Week 3 | 30.5 units on a scale | Standard Deviation 16.1 |
| Experimental | Inventory of Depressive Symptomatology | Week 5 | 31.9 units on a scale | Standard Deviation 15.2 |