rTMS for Treatment of Depressed Phase of Bipolar Disorder Type II
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: Bipolar Disorder
In brief
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.
Key facts
- Study ID
- NCT00447096
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 0
- Starts
- 2007-02-01
- Expected to finish
- 2010-02-01
- Last updated by the study team
- 2016-06-09
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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