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Pilot Accelerated Theta Burst in Treatment-Resistant Bipolar Depression
Not Recruiting
Trial ID: NCT03953417
Purpose
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant bipolar depression. In this open-label study, all participants will receive accelerated theta-burst stimulation.
Official Title
Pilot Accelerated Theta Burst Stimulation in Treatment-Resistant Bipolar Depression
Stanford Investigator(s)
Nolan Williams
Associate Professor of Psychiatry and Behavioral Sciences (Major Laboratories & Clinical Translational Neurosciences Incubator) and, by courtesy, of Radiology (Neuroimaging and Neurointervention)
Ian H. Kratter, MD, PhD
Clinical Assistant Professor, Psychiatry and Behavioral Sciences
Eligibility
Inclusion Criteria:
* Male or female, 18 to 80 years of age.
* Able to provide informed consent.
* Diagnosed with Bipolar Disorder and currently experiencing a Major Depressive Episode (MDE).
* Meet the threshold on the total MADRS score of \>/=20 at baseline.
* In good general health, as ascertained by medical history.
* If female, a status of non-childbearing potential or use of an acceptable form of birth control.
* History of rTMS failure with FDA approved rTMS parameters is permitted.
Exclusion Criteria:
* Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
* Female that is pregnant or breastfeeding.
* Female with a positive pregnancy test at participation.
* Total MADRS score of \< 20 at study entry.
* Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence.
* Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, or Specific Phobia (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more).
* History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
* Any Axis I or Axis II Disorder, which at screening is clinically predominant to their bipolar depression or has been predominant to their bipolar depression at any time within six months prior to screening.
* Considered at significant risk for suicide during the course of the study.
* Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
* Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
* Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
* History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
* Current (or chronic) use of opiates.
* History of epilepsy.
* History of shrapnel or metal in the head or skull.
* History of cardiovascular disease or cardiac event.
* History of OCD.
* History of autism spectrum disorder.
* Current psychosis
* Any change in medication of which the study PI is not aware of.
Intervention(s):
device: Accelerated intermittent theta-burst treatment
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nolan Williams, MD