rTMS for Treatment of Depressed Phase of Bipolar Disorder Type II (rTMS)

June 8, 2016 updated by: University of Texas Southwestern Medical Center

rTMS (Repetitive Transcranial Magnetic Stimulation) for Acute Treatment of Depressed Phase of Bipolar Disorder Type II

This research study evaluates an experimental device for the treatment of the depressed phase of Bipolar Disorder Type II. Repetitive Transcranial Magnetic Stimulation (rTMS) is an experimental procedure where a device delivers an alternating magnetic field to a focal area of the brain. When the coil is placed against the scalp on the left frontal area of the head, the magnetic field is focused to a region of the brain that is thought to be involved in depression. This study is intended to test if rTMS can affect this region of the brain in a way that improves the symptoms of depression related to Bipolar Disorder Type II. The purpose of this study is to obtain safety and efficacy information regarding the use of rTMS(Repetitive Transcranial Magnetic Stimulation) for patients in the depressed phase of Bipolar Disorder Type II.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind randomized controlled trial of rTMS for outpatients in the depressive phase of BD-II. Participants will be evaluated at UT Southwestern Medical Center at Dallas. Forty eligible subjects will be randomized to either active treatment (n=20) or sham (no stimulation, n=20). Each subject will receive treatment 5 days per week for a total of 6 weeks. At the end of the 6 weeks, those who remain depressed will have the option of receiving 6 additional weeks of open rTMS treatment. We require these participants to meet the same eligibility criteria in the open phase (i.e. MADRS ≥15, YMRS <12) as in the initial double blind phase. At the completion of treatment, a follow-up appointment will be scheduled with a study physician to ensure that the participant is properly transitioning to clinical care and is not having a significant change in clinical status. Those who do not already have a treating physician will be referred to a new provider.

Study Type

Interventional

Phase

  • Phase 2

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
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center at Dallas

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:

  • Male and female outpatients aged 18-55 years old
  • Meet DSM-IV criteria for Bipolar Affective Disorder Type II, depressed phase without psychosis as determined by Structured Clinical Interview for DSM-IV
  • A MADRS ≥ 15 at Initial Visit, and at Prior to TMS Evaluation
  • A Young Mania Rating Scale < 12 at Initial Visit and at Prior to TMS Evaluation
  • Duration of current episode of depression >2 months but ≤ 1 year of unsuccessful treatment
  • On stable medication and/or psychotherapy for 1 month and clinically appropriate to maintain for duration of trial
  • Cognitively intact (Folstein MMSE score >24).
  • Clinically competent to give informed written consent

Exclusion Criteria:

  • History of epilepsy or seizure disorder, mass brain lesions, cerebrovascular accident, metal in the skull, a history of major head trauma, or any neurologic condition likely to increase risk of rTMS.
  • Suicidal risk that precludes safe participation defined as score of 5 or 6 on MADRS item 10 Suicidal Thoughts or clinical impression that the subject is at significant risk for suicide.
  • History of any DSM-IV Axis I diagnosis other than Bipolar Affective Disorder Type II, depressed phase, simple phobia and generalized anxiety disorder (GAD) in the last year
  • Lifetime history of schizophrenia, schizoaffective, or other psychotic disorder, bipolar disorder type I, dementia, dissociative disorders, and sexual and gender identity disorder
  • Personality disorder that makes participation in the trial difficult
  • Greater than or equal to 8 episodes of mood disturbance in the previous 12 months
  • Greater than 4 unsuccessful treatments in current episode
  • History of Substance Abuse or Dependence (DSM-IV) in the last year except nicotine and caffeine
  • Positive urine drug test during screening
  • Taking any medication that significantly lowers the seizure threshold (e.g. lithium, stimulants, bupropion, TCAs, antipsychotics, theophylline, etc.)
  • Unstable medical conditions that precludes safe participation in rTMS treatment trial
  • Known or suspected pregnancy
  • Women of child-bearing potential not using medically accepted form of contraception when engaged in sexual intercourse
  • Any metal or device implants that would increase risk of rTMS
  • Unable to determine the motor threshold in the subject
  • History of Vagus Nerve Stimulation
  • Currently in another investigational study
  • Prior electroconvulsive therapy failure

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Treatment arm will receive treatment 5 days a week for 6 weeks. Repetitive transcranial magnetic stimulation (rTMS) treatment.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Repetitive transcranial magnetic stimulation (rTMS).
Sham Comparator: Sham Arm
Sham Arm will not receive any stimulation 5 days a week for 6 weeks. Sham transcranial magnetic stimulation.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Repetitive transcranial magnetic stimulation (rTMS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
QIDS-C (Quick Inventory of Depressive Symptomatology-Clinical Rated)
Time Frame: 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
MADRS(Montgomery Asberg Depression Rating Scale)
Time Frame: 3 year
3 year
IDS-C (Inventory of Depressive Symptomatology- Clinician Rated)
Time Frame: 3 year
3 year
QIDS-SR (Quick Inventory of Depressive Symptomatology-Self Report)
Time Frame: 3 year
3 year
YMRS (Young Mania Rating Scale)
Time Frame: 3 year
3 year
Neuropsychological Testing
Time Frame: 3 year
3 year
rTMS safety/adverse events
Time Frame: 3 year
3 year

Collaborators and Investigators

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

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Stanley Medical Research Institute
Neuronetics

Investigators

  • Principal Investigator: F. Andrew Kozel, MD, MSCR, UT Southwestern Medical Center at Dallas

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

February 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 14, 2007

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102006-040

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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