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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Disease
Mood Disorders
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014