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
Ian H. Kratter, MD, PhD

Clinical Assistant Professor, Psychiatry and Behavioral Sciences

Nolan Williams
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