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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00699218
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : October 12, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Mood Disorder Bipolar Disorder Major Depression Depression Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K. Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment of Bipolar Depression
Study Start Date : May 2008
Primary Completion Date : July 2009
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :
  1. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Baseline, weekly during treatment, and at 2-week follow-up ]

Secondary Outcome Measures :
  1. Inventory of Depressive Symptomatology [ Time Frame: Base line, weekly during treatment, and at 2-week follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699218

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
Principal Investigator: Guohua Xia, M.D., Ph.D. Department of Psychiatry and Behavioral Sciences, UC Davis
More Information

Additional Information:
Responsible Party: Guohua Xia, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00699218     History of Changes
Other Study ID Numbers: 200715749-1
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012

Keywords provided by Guohua Xia, University of California, Davis:
repetitive Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Depressive Disorder, Major
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Bipolar and Related Disorders