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

October 20, 2017 updated by: University of California, Davis

A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment of Bipolar Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95618
        • Center for Mind and Brain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS treatment
Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim
Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.
High frequency repetitive TMS given daily on weekdays for 3 weeks
Other Names:
  • Repetitive Transcranial Magnetic Stimulation (rTMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression (HAM-D)
Time Frame: 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.
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inventory of Depressive Symptomatology
Time Frame: 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.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

October 20, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200715749

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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