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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)
Ian H. Kratter, MD, PhD
Clinical Assistant Professor, Psychiatry and Behavioral Sciences
Nolan Williams
Associate Professor of Psychiatry and Behavioral Sciences (Major Laboratories & Clinical Translational Neurosciences Incubator) and, by courtesy, of Radiology (Neuroimaging and Neurointervention)
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