rTMS for Treatment of Depressed Phase of Bipolar Disorder Type II

This study has suspended participant recruitment.
(Suspended due to lack of funding)
Sponsor:
Collaborators:
Stanley Medical Research Institute
Neuronetics
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00447096
First received: March 12, 2007
Last updated: June 4, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: rTMS (Repetitive Transcranial Magnetic Stimulation) for Acute Treatment of Depressed Phase of Bipolar Disorder Type II

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • QIDS-C (Quick Inventory of Depressive Symptomatology-Clinical Rated)

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

Estimated Enrollment: 40
Study Start Date: February 2007
Estimated Study Completion Date: February 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00447096

Locations
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Stanley Medical Research Institute
Neuronetics
Investigators
Principal Investigator: F. Andrew Kozel, MD, MSCR UT Southwestern Medical Center at Dallas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00447096     History of Changes
Other Study ID Numbers: 102006-040
Study First Received: March 12, 2007
Last Updated: June 4, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Bipolar Type II
Depression
rTMS

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014