A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Bipolar Depression (TMS-BD)
This study has been completed.
Sponsor:
University of California, Davis
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Guohua Xia, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00699218
First received: June 4, 2008
Last updated: October 10, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mood Disorder Bipolar Disorder Major Depression Depression |
Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K. |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment of Bipolar Depression |
Resource links provided by NLM:
Further study details as provided by University of California, Davis:
Primary Outcome Measures:
- Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Baseline, weekly during treatment, and at 2-week follow-up ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Inventory of Depressive Symptomatology [ Time Frame: Base line, weekly during treatment, and at 2-week follow-up ] [ Designated as safety issue: Yes ]
| Enrollment: | 15 |
| Study Start Date: | May 2008 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental
Active rTMS treatment
|
Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.
High frequency repetitive TMS given daily on weekdays for 3 weeks
Other Name: Repetitive Transcranial Magnetic Stimulation (rTMS)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699218
Locations
| United States, California | |
| Center for Mind and Brain | |
| Davis, California, United States, 95618 | |
Sponsors and Collaborators
University of California, Davis
National Alliance for Research on Schizophrenia and Depression
Investigators
| Principal Investigator: | Guohua Xia, M.D., Ph.D. | Department of Psychiatry and Behavioral Sciences, UC Davis |
More Information
Additional Information:
No publications provided
| Responsible Party: | Guohua Xia, Principal Investigator, University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00699218 History of Changes |
| Other Study ID Numbers: | 200715749-1 |
| Study First Received: | June 4, 2008 |
| Last Updated: | October 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Davis:
|
Bipolar Depression TMS repetitive Transcranial Magnetic Stimulation |
treatment Efficacy Safety |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Depressive Disorder, Major |
Mood Disorders Affective Disorders, Psychotic Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013