NCT00699218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
8.3 years until next milestone

Results Posted

Study results publicly available

July 23, 2018

Completed
Last Updated

July 23, 2018

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

June 4, 2008

Results QC Date

April 11, 2017

Last Update Submit

October 20, 2017

Conditions

Mood DisorderBipolar DisorderMajor DepressionDepression

Keywords

BipolarDepressionTMSrepetitive Transcranial Magnetic StimulationtreatmentEfficacySafety

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 weeks

Secondary Outcomes (1)

  • Inventory of Depressive Symptomatology

    5 weeks

Study Arms (1)

rTMS treatment

EXPERIMENTAL

Active rTMS treatment. Transcranial magnetic stimulation using a device called MagStim

Device: Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.

Interventions

Magnetic Stimulator Rapid2 made by Magstim Company Ltd. U.K.DEVICE

High frequency repetitive TMS given daily on weekdays for 3 weeks

Also known as: Repetitive Transcranial Magnetic Stimulation (rTMS)
rTMS treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Mind and Brain

Davis, California, 95618, United States

Location

Related Links

MeSH Terms

Conditions

Mood DisordersBipolar DisorderDepressive Disorder, MajorDepression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mental DisordersBipolar and Related DisordersDepressive DisorderBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Results Point of Contact

Title
Guohua Xia
Organization
UC Davis
gxia@ucdavis.edu
916-734-3574

Study Officials

  • Guohua Xia, M.D., Ph.D.

    Department of Psychiatry and Behavioral Sciences, UC Davis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 17, 2008

Study Start

May 1, 2008

Primary Completion

July 1, 2009

Study Completion

April 1, 2010

Last Updated

July 23, 2018

Results First Posted

July 23, 2018

Record last verified: 2017-10

Locations

US(1)